A Dissertation on COMPARISON OF MIFEPRISTONE WITH FOLEY'S CATHETER FOR INDUCTION OF LABOUR IN POST DATED PREGNANCY
Dissertation submitted to THE TAMILNADU DR.M.G.R.MEDICAL UNIVERSITY CHENNAI-600032 With partial fulfillment of the requirements for the award of M.S.DEGREE IN OBSTETRICS AND GYNAECOLOGY (BRANCH VI) Reg No:221716303
COIMBATORE MEDICAL COLLEGE, COIMBATORE MAY 2020
DECLARATION
I Dr. DHIVYA.M. solemnly declare that the dissertation
entitled “ COMPARISON OF MIFEPRISTONE WITH
FOLEY'S CATHETER FOR INDUCTION OF LABOUR IN
POST DATED PREGNANCY” is a bonafide work done by me
at Coimbatore Medical College Hospital during the year Jan 2018
to Dec 2018 under the supervision of Dr.RMANONMANI,
M.D,D.G.O, Professor& Head of Department, Department of
Obstetrics and Gynaecology, Coimbatore Medical College &
Hospital. The dissertation is submitted to Dr.MGR Medical
University towards partial fulfillment of requirement for the award
of MS degree Obstetrics and Gynaecology.
PLACE: Dr. DHIVYA.M
DATE:
CERTIFICATE
This is to certify that the dissertation entitled “COMPARISON OF MIFEPRISTONE WITH FOLEY'S CATHETER FOR INDUCTION OF LABOUR IN POST DATED PREGNANCY”is a bonafide original work done by Dr.DHIVYA.M.Post graduate student in the Department of OBSTETRICS AND GYNAECOLOGY , Coimbatore Medical College Hospital, Coimbatore under the guidance of Dr.R.MANONMANI (M.D,D.G.O), Professor and HOD of Department, Department of OBSTETRICS AND GYNAECOLOGY, Coimbatore Medical College Hospital, Coimbatore in partial fulfillment of the regulations for the Tamilnadu DR.M.G.R Medical University, Chennai towards the award of M.S., degree (Branch VI) in Obstetrics and Gynaecology.
Date : GUIDE Dr.N.GEETHA, M.D.OG, Professor, Department of Obstetrics and Gynaecology, Coimbatore Medical College & Hospital.
Date : Dr.R.MANONMANI, M.D,D.G.O, Professor & HOD, Department of Obsterics and Gynaecology, Coimbatore Medical College & Hospital.
Date : Dr.B.ASOKAN, M.S., Mch., Dean, Coimbatore Medical College & Hospital, Coimbatore.
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Declaration by the Candidate
I hereby declare that The Tamilnadu DR.M.G.R Medical University,
Chennai shall have the rights to preserve, use and disseminate this dissertation/thesis in print or electronic format for academic/research purpose.
PLACE: COIMBATORE Dr. DHIVYA.M DATE:
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MIFEPRISTONE WITH FOLEY’S CATHETER FOR INDUCTION OF
LABOUR IN POST DATED PREGNANCY" of the candidate
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Signature of the Guide
ACKNOWLEDGEMENT
I solicit my humble thanks to the Dean Dr.B.Asokan, M.S.,
Mch.,Coimbatore Medical College Hospital, for allowing me to conduct the study in this hospital.
I would like to express my gratitude and indebtness to our Prof and HOD,
Dr.R.MANONMANI,M.D,D.G.O, Department of Obstertrics and Gynaecology for her motivation and support.
I am also immensely thankful to my guide Prof.
Dr.N.GEETHA,M.D,OG. Professor, Department of Obstetrics and
Gynaecology for her invaluable guidance, motivation and help throughout the study.
I express my earnest gratitude to all Professors, Department of Obstetrics and Gynaecology Dr. K.Murugalakshmi, M.D,D.G.O, Dr.Mohanasundari
M.D,OG,Dr.P.Thilagavathy M.D,OG, without their help and guidance this work would not have been possible.
I thank all my Assistant professors who helped me to accomplish my study.
I owe a lot to my parents, my spouse Dr. D.Senthil kumar and other family members who have always been my pillar of support in all stages of my life.
I thank my seniors and my fellow post graduate colleagues who have been of immense help throughout the study period.
I am very grateful to all patients for their co-operation and participation in the study.
CONTENTS
SL.NO TITLES PAGE NO
1 INTRODUCTION 1
2 AIMS AND OBJECTIVES 3
3 4 REVIEW OF LITERATURE 4 THEORETICAL BACKGROUND 8
5 MATERIALS AND METHODS 63
6 OBSERVATION AND RESULTS 66
7 DISCUSSION 79
8 SUMMARY 81
9 CONCLUSION 83
10 BIBLIOGRAPHY 84
ANNEXURES 11 98
LIST OF TABLES
SL.NO TABLES PAGE NO
1 Modified Bishop’s score 33
2 Distribution of Study Participants 66
3 Mean Age of the study group 68
4 Association of Parity with type of induction 69
Association between mode of delivery and 5 71 type of induction
Association between induction –delivery 6 73 interval and type of induction
Association between the neonatal outcome and 7 75 type of income
Association between induction type and 8 77 incidence of PPH
LIST OF CHARTS
SL.No CHARTS PAGE No
1 Flow chart for management of post dated pregnancy 31
2 Distribution of study participants 67
3 Distribution of mean age of the study group 68
4 Association between parity and type of induction 70
Association between mode of delivery and type of 5 72 induction
Association between duration of delivery and 6 74 induction type
Association between neonatal outcome and induction 7 76 type
Association between induction type and incidence of 8 78 PPH
LIST OF FIGURES
SL.NO FIGURE PAGE NO Formation Of Physiological And Pathological 1 12 Retraction Ring
2 Image showing Mechanism of Labour 14
3 FRIEDMAN’S curve for labour monitoring 16
4 Image showing Bag of membranes formation 17
5 Bearing down efforts and fetal expulsion 20
6 Placental seperation 22
7 Sweeping of membranes 35
8 Amniotomy 37
9 Synthesis of Prostaglandins 41
10 Mechanism of action of PGE2 43
11 Intracervical application of PGE2 44
12 Chemical structure of Mifepristone 46
13 Three dimensional image of Mifepristone 47
Mechanism of action of Mifepristone 48 14 15 Image of Foley’s catheter 52
Image showing cervical dilatation and 16 55 effacement
17 Image of a double balloon catheter 57
18 Insertion of double balloon catheter 58
19 Picture of Laminaria tent 59
20 Insertion of Laminaria tent 61
LIST OF ABBREVIATIONS
ACOG American College of Obstetrics and Gynaecology
ANC Antenatal clinic
ARM Artificial rupture of membranes
BMI Body Mass Index
C/S Caeserean section
CPD Cephalo-pelvic disproportion
FIGO International Federation of Obstetrics and Gynaecology
PGs Prostaglandins
PGE1 Misoprostol
PGE2 Dinoprostone
RU 486 Mifepristone
RCOG Royal College of Obstetricians and Gynaecologists
WHO World Health Organization
MLCK Myosin Light Chain Kinase
LIST OF NOMENCLATURE
Expected date of delivery(EDD)- 280 days or 40 completed weeks from the last menstrual period.
Post-maturity: Post-maturity or Post-maturity Syndrome (PMS) can only be diagnosed after delivery and is defined as a post-dated pregnancy accompanied with any combination of the following newborn assessments a. No Lanugo ( fine body hair ) b. Long Nails c. Abundant Hair On Head d. Calcified Fetal Skull e. Hanging Or Wrinkled Skin, With The Appearance Of Weight Loss f. Dehydrated g. Alert Face h. Peeling Skin i. Little or No Vernix j. Oligohydramnios k. Meconium or bile staining of skin and long, thin growth retarded body
with long thin limbs. Induction of labor: Artificial initiation of contractions in a pregnant woman who is not in labor to help her achieve a vaginal birth within 24 to 48 hours.
Successful induction: A vaginal delivery within 24 to 48 hours of induction of labor.
Elective induction: Induction of labor in the absence of acceptable fetal or maternal indications.
Cervical ripening: Use of pharmacological or other methods to soften, efface, or dilate the cervix to increase the likelihood of a vaginal delivery.
Tachysystole: More than 5 uterine contractions in 10 minute period averaged over 30 minutes. This is further subdivided into two categories, one with and one without fetal heart rate changes.
Hypertonus: Excessive uterine contractions lasting more than 120 seconds without fetal heart rate changes.
Hyperstimulation: Excessive uterine contractions (tachysystole or hypertonus) as a result of induction of labor with nonreassuring fetal heart rate changes
Amniotomy: Artificial rupture of the membranes to initiate or speed up labor.
Failed induction: Failure to achieve regular uterine contractions (every 3 minutes) after one cycle of completion of cervical ripening consisting of a) Insertion of three intracervical PGE2 gel (3gm) at 6-hourly intervals, and 12-24 hours of oxytocin administration after rupture of membranes, if feasible, or
b) One PGE2 pessary (10 mg) within 24 hours.
ABSTRACT TITLE:
COMPARISON OF MIFEPRISTONE WITH FOLEY’S
CATHETER FOR INDUCTION OF LABOR IN POST DATED
PREGNANCY.
BACKGROUND AND OBJECTIVES:
Induction of labor is artificial initiation of uterine contractions before spontaneous onset of labor or after the period of viability of the fetus. Induction of labour is indicated when complications of pregnancy may have a negative impact on the health of the mother, fetus, or both. Induction of labour is therapeutic option when the benefits of the delivery outweigh the risks of continuing the pregnancy. Routine antenatal ultrasound for confirmation of EDD has been shown to reduce induction rates for post dated pregnancies after correction of dates. Prolonged pregnancy is known to be associated with significantly increased risks of perinatal and maternal complications. . Induction of labour is planned for many indications.In this study induction of labour done for post dated pregnancies was taken into account.The purpose of this study is to compare the efficacy of mifepristone with foley’s catheter for induction of labour in post dated pregnancies.The drug have been chosen for the above study based on cost factor,safety profile and the results shown by previous studies.This will be of very use in future management of post dated pregnant woman planned for induction of labor.
METHODOLOGY:
This is a randomized comparative study conducted from Jan 2018 to Dec
2018 in Department of Obstetrics and Gynaecology,Coimbatore Medical
College Hospital.Two hundred post dated pregnant mothers were enrolled in the study based on inclusion and exclusion criteria.
All patients were explained about the study and informed written consent was obtained from them in the language of their convenience.A thorough history regarding the regularity of menstrual cycle,LMP,dating scan,risk factors of post dated pregnancy,past obstetric history were obtained and recorded.Complete systemic and obstetric examination were done in all patients.Complete blood count,blood sugar, renal function test, ultrasound obstetrics were done in all patients.
Per vaginal examination done to assess adequacy of pelvis,the bishop’s score of the patients included in the study.The results obtained by considering the following parameters,
Changes in the bishop’s score,
Induction delivery interval,
Mode of delivery,
Neonatal outcome,
Incidence of PPH. Patients were randomised into two groups. One group were treated with Tab.
Mifepristone and another group were treated with Foley’s catheter. After 24 hours, the treatment results were noted by change in the Bishop's score, need for further induction with prostaglandins or augmentation with ARM or oxytocin, fetal heart rate monitoring to rule out fetal distress, mode of delivery, induction delivery interval, incidence of PPH.
Thus the efficacy of Mifepristone with Foley’s catheter for induction of labor in post dated pregnancies were studied and compared.
RESULTS:
Our study included 200 patients out of which 100 were treated with
Mifepristone,100 were treated with Foley’s catheter. Among the study group,
135 women are Primigravida and 65 women are multigravida.
The mean age for the women in the study group were in between 24 -25 yrs.The mode of delivery in the women who were enrolled in the study was found to be significant as 84% of patient in mifepristone group delivered vaginally compared to 64% in foley’s induction group.16% patients were undergone caesarean section in mifepristone group as compared to 33% in the foley’s induction group.The mean duration of induction –delivery interval was found to be 26 hours in mifepristone group compared to 36 hours in foley’s group.The incidence of respiratory distress in mifepristone group was found to be 3% compared to 12% in foley’s group.The incidence of PPH observed in the study was found to be insignificant. CONCLUSION:
Thus, based on the results observed in our study, Tab.Mifepristone can be considered as effective in induction of labour in post dated pregnancy.
Keywords : Induction of labor,Postdated, pregnancy,Mifepristone,Foley's catheter,induction-delivery interval,neonatal outcome. INTRODUCTION
Induction of labour is defined as the stimulation of uterine contractions to bring about the delivery before the onset of spontaneous labour or after the period of viability.
Induction of labour is indicated when complications of pregnancy may have a negative impact on the health of the mother, fetus, or both. Induction of labour is therapeutic option when the benefits of the delivery outweigh the risks of continuing the pregnancy.
There are many methods for induction of labour. In this study one group was induced with Tab.Mifepristone another group was induced with foley’s catheter.
Induction of labour is planned for many indications.In this study induction of labour done for post dated pregnancies was taken into account.
Routine antenatal ultrasound for confirmation of EDD has been shown to reduce induction rates for post dated pregnancies after correction of dates[1,2]
1
This study is done in a developing country like India at
Coimbatore medical college hospital to find the efficacy of mifepristone and foley’s catheter for induction of labour in post dated pregnancy as a part of routine elective induction in inpatients admitted for safe confinement.
2
AIMS AND OBJECTIVES
To compare the safety and efficacy of mifepristone and foley’s catheter for induction of labour in post dated pregnancies
3
REVIEW OF LITERATURE
Lata G et al study showed in term pregnancy and in patients with unripe cervix mifepristone was effective in cervical ripening and inducing labour. In this study 80% of patients in study group showed improvement in cervical ripening compared to 50% patients in control group. 70% patients in study group delivered within 48 hours as compared to 38% patients in control group[3]
In a study conducted by RUTUJA ATHAWALE, the inducing agent Mifepristone acts by increasing uterine contractility and uterine sensitivity to the actions of prostaglandin. In this study, the women showed drastic improvement in cervical score within 24-48 hours after induced with oral mifepristone and the cesarean rate was decreased and amount of dose requirement for augmentation of labour with
Misoprostol or Oxytocin, lesser NICU admission and maternal complication in the study group as compared to placebo group.[4]
Kanan yelikar studied the efficacy of mifepristone in cervical ripening and induction of labour in prolonged pregnancy .In this study there was 100 subjects, out of which 50 received mifepristone and 50 received placebo. Mean induction to delivery interval ,mean Bishop score was analysed after 24 hours. 16 % women in Study Group and 4 % women in Control Group delivered vaginally within 24 h without any
4 need of augmentation. There was 12 % caesareans and 4 % instrumental deliveries in Study Group as compared to 16 % and 10 % respectively in the Control Group. In both groups no statistically significant difference in perinatal outcomes. Mifepristone has modest effect on cervical ripening and reduces need for misoprostol compared with placebo.[5]
In a study Byrne demonstrated that after exposure to mifepristone venous blood samples were taken to measure serum cortisol, CRH,
ACTH at 0,3,6 hours then every 6 hours till delivery.in study group there was no significant elevation in ACTH and CRH levels rather than there is significant elevation in cortisol levels was observed within 18 h of exposure to mifepristone as a matter of response to stress(progress of labour).[6]
In a study conducted by Wing DA, among 180 subjects 97 were given mifepristone and 83 were given placebo. Out of which 87.5% in mifepristone group delivered vaginally after 48 hrs of treatment compared to 46% in placebo groups. variations in fetal heart rate pattern and changes in uterine contractilities were noted in mifepristone groups.
The neonatal outcome was found to be same in both groups.[7]
Hapangama et al compared the usage of mifepristone in third trimester cervical ripening and labour induction with placebo. The results are mifepristone treated groups entered into labour and bishop score
5 improvement within 48 hours and this effect persisted for 96 hours. There is insufficient information regarding uterine rupture and dehiscence in cases of previous caesarean deliveries[8].
Atawale et al.[9] and Fathima et al. [10] also noted the significant change in Bishop score with the use of oral mifepristone after 24 hours of administration.
In a study conducted by Dr gautham aher the effect of mifepristone on cervical score by comparing the pre and post induction bishop’s score. There was a significant improvement in bishop’s score noted in mifepristone group than placebo group.[11]
Dharani H reported that mifepristone-treated women were less likely to undergo C/S due to failure of induction and the need of augmentation with oxytocin is reduced when compared to placebo.[12]
In a study conducted by Baburam dixit two groups are there one is induced with foley’s catheter another is induced with misoprostol, the results are in foley’s induction group,80 went into normal labour,16 had caesarean deliveries,1 had vaccum delivery,9 patients delivered with meconium stained liquor,1 still birth,no hyper stimulation was noted.[13]
W Chen studied the effects of foley’s catheter, oral misoprostol and dinoprostone for cervical ripening in induction of labour. The results
6 showed that vaginal misoprostol was most effective in achieving vaginal delivery within 24 hours with high incidence of uterine hyperstimulation. lower incidence of hyperstimulation was noted with foley’s catheter.C/S rates were lower with oral misoprostol.[14]
In a study done by Mieke L and tenEikelder foley’s catheter showed better safety profile in women with unripe cervix at term as compared to misoprostol.in this study there was lesser incidence of hyperstimulation, fewer instrumental deliveries, lesser caesarean deliveries than misoprostol[15]
7
THEORETICAL BACKGROUND
Labor is a process by which the fetus after the period of viability, is expelled from the genital tract.
According to WHO Normal labor is defined as
Onset is spontaneous
Term gestation {37-42 weeks}
Vertex presentation
Uncomplicated
Natural expulsive forces
Vaginal delivery
Preterm labor is onset of labor before 37 weeks of geststion.
PHYSIOLOGY OF ONSET OF LABOR
The basis of uterine contractility is the interaction between actin and myosin in myometrial smooth muscle cells. This is brought by calcium through Ca2+–calmodulin‐dependent myosin light chain kinase
(MLCK) activity. The calcium sensitisation in smooth muscle occurs through activation of Rho kinase, a calcium‐independent pathway that promotes contractility by inhibiting myosin phosphatase and probably by
8 phosphorylating myosin on the same site as MLCK. Uterine activity can be modulated by many G‐protein coupled receptors (GPCRs )
1.Receptors coupled to Gαq (oxytocin‐, prostanoid FP and TP, endothelin‐receptors) stimulate contractility by activating the phospholipase C/Ca2+ pathway
2.Receptors coupled to Gαs (β2‐adrenoceptors, prostanoid EP2 and
IP, some 5‐hydroxytryptamine receptors e.g. 5‐HT7) relax the uterus by increasing myometrial cyclic AMP levels
3.Receptors coupled to Gαi (α2‐adrenoceptors, muscarinic,
5‐HT1) potentiate contractility, probably by inhibiting cAMP production.
Recent evidence showed that fetal adrenal cortisol induces prostaglandin synthase type 2 in placental trophoblast and that the resulting increase in prostaglandin E2 participates in the activation of the
P450 cascade The endocrine imbalance promotes increased intrauterine production of prostaglandins, cervical softening and the onset of myometrial contractions [17]
The progress of normal labor depends upon interaction between the 3 P’s
9
Passage
Passenger
Power
PASSAGE
The passage consists of both bony pelvis and soft tissues. Shapes and diameters of the true pelvis assessed by clinical pelvimetry.
The soft tissues (cervix and pelvic muscles) undergo some changes during labor that favors descent of the fetus through the pelvis.
PASSENGER
Fetal factors leading to successful vaginal delivery are
Vertex presentation
Longitudinal lie
Average weight
Well flexed attitude
Left occipito anterior position.
10
Factors leading to poor prognosis to successful vaginal delivery
Fetal weight >4 kg
Deflexed head
Occipito posterior position
Malpresentations such as breech ,brow and face.
POWER
Uterine contractions play a major role in the process of labor.as the labor goes on ,interval between the contractions gradually decreases and it’s intensity increases.5 contractions in ten minutes is considered normal.
Intra amniotic pressure as measured by intrauterine pressure catheter is measured 20-40 mmHg. The strength of the contractions is expressed in Montevideo units.
As the uterus contracts there is formation of upper and lower uterine segment, physiologic retraction ring formation, increase in hydrostatic pressure dilates the cervical canal hence bag of membranes is formed.
11
IMAGE 1
FORMATION OF PHYSIOLOGICAL AND PATHOLOGICAL
RETRACTION RING
12
MECHANISM OF NORMAL LABOUR
It is defined as the process by which the fetus adjust it’s position throughout the labor so as to accommodate the pelvic canal and favors the delivery of the fetus.
To understand the mechanism and management of labour we should first know the
Physiological mechanisms of labour[16,17]
The cardinal movements of labor are,
1. Engagement
2.Descent
3.Flexion
4.Internal rotation
5.Extension
6.Restitution
7.External rotation
8.Expulsion.
13
The most important movements among these is internal rotation which occurs at the level of ischial spines bringing the occiput anterior thereby extension occurs and delivery of the fetus.
IMAGE 2
MECHANISM OF LABOUR
A-engagement& descent, B-flexion, C-internal rotation, D-extension,
E-restitution, F-external rotation.
14
Labor is a continuous process. It is divided into three stages.
1.First stage : Stage of dilatation
2.Second stage : Stage of expulsion of fetus
3.Third stage : Placental expulsion
PRELABOUR OR PREPARATORY STAGE OF LABOR
The preparatory changes like cervical changes, engagement of the fetal head, takes place few weeks prior to onset of labor.
FOURTH STAGE OF LABOR
In this stage contraction and retraction of the uterus and arrest of bleeding occurs. The duration is 1-2 hours after delivery. PPH due to atony can occur close monitoring is needed.
FIRST STAGE
Starts from onset of true labor pains to full dilatation of cervix
Events :
1 . Regular and painful uterine contractions which progressively
increases in intensity ,duration ,frequency.
2 . Show
15
3 . Effacement and dilatation of cervix. Cervical dilatation is divided
into two phases,
a) latent phase
b) active phase- acceleration phase,
phase of maximum slope,
deceleration phase,
IMAGE 3
FRIEDMAN’S CURVE FOR LABOUR MONITORING
4 .Lower uterine segment formation
5 .Descent of presenting part
6 .Bag of membranes formation.
16
Duration of first stage of labor
Nullipara-6-8 hours
Multipara-4-6 hours
Rate of cervical dilatation
Nullipara-1.2 cm/hr
Multipara-1.5cm/hr
Minimum-1 cm/hr
17
IMAGE 4
BAG OF MEMBRANES FORMATION
18
SECOND STAGE
Starts from full dilatation of cervix to delivery of fetus.
1. It consists of two phases,
a. Pelvic phase or phase of descent-full dilatation to the time when head reaches the pelvic floor which is identified by the bearing down efforts.
b. Perineal phase or phase of expulsion-starting of bearing down efforts to delivery of fetus.
2. Uterine contractions increase in frequency and duration.
3. Bearing down efforts
4. Crowning
5. Expulsion of fetus.
19
IMAGE 5
BEARING DOWN EFFORTS AND EXPULSION OF FETUS
THIRD STAGE
Stage of placental expulsion
Placental separation consists of 4 phases
1. Latent phase-placenta free wall of the uterus contracts
2. Contraction phase-uterine wall at the placental site contracts
3. Detachment phase- placenta seperates from the uterine wall
4. Expulsion phase-placenta expelled from the uterine cavity
20
SIGNS OF PLACENTAL SEPERATION
Well contracted uterus
Gush of blood coming from vagina indicating complete or partial separation
Lengthening of the cord
Placenta descends
Uterus becomes hard, round and mobile.
PLACENTAL SEPERATION METHODS
There are two methods,
1. Schultze-centre of the placenta seperates first and comes out as an
inverted umbrella.
2. Duncan method-margins of the placenta seperates first followed by
the central part.
21
IMAGE 6
METHOD OF PLACENTAL SEPARATION
A-Schultze method
B-Duncan method
After confirming the placental separation by per vaginal examination, placenta was delivered by controlled cord traction method.(Brandt
Andrew method)[18]
22
Induction of labour is the iatrogenic stimulation of uterine contractions before the onset of spontaneous labour, to accomplish vaginal delivery. It is performed when the benefits of expeditious delivery to either mother or fetus outweigh the risk of continuing the pregnancy.
Labour may be induced because of maternal or fetal indications
MATERNAL INDICATIONS
Post dated or post term pregnancy
Preterm, prelabour rupture of membranes(PPROM)
Prelabour rupture of membranes(PROM)
Placental abruption
Hypertensive disorders
Gestational hypertension
Pre eclampsia
Eclampsia
Chronic hypertension
Diabetes mellitus(GDM)
23
Anti phospholipid antibody syndrome(APLA)
Intrauterine fetal demise(IUFD)
FETAL INDICATIONS
Fetal growth restriction(FGR)
Oligohydramnios
Rh alloimmunisation
Non reassuring fetal heart rate pattern
Induction of labour is a relatively common procedure. The rate of induction of labour may differ depending on the availability of resources and population. Worldwide, the prevalence of labour induction varies greatly between countries and even between different regions of the same country. In general, however, it is higher in developed countries (at around 20%) than in developing countries [19].
In the Western world, frequency of labour induction has been increasing, with reasons including the availability of better cervical ripening agents, patient and clinicians desire to arrange a convenient time of delivery, and more relaxed attitudes toward marginal indications for induction [19]. Patient or provider concerns about the risk of fetal demise with expectant management of post-term pregnancies have also
24 contributed to the increased rate of induction[19,20]]. In the United
Kingdom according to the National Health Survey (NHS), one in every five live births is induced half of which are due to post-term pregnancies
[21,22].In another study in Sweden, the rate of induction in nulliparous women was as high as 40% with post-dates being the major indication.
[23]
From observational studies it has been found that nulliparous women have a higher failure rate than multiparas and also induction has been known to fail when the bishop score is five or less.[24]. However no such study has been carried out specifically for post-term pregnancies and the rate of successful induction of prolonged pregnancies with such factors world-wide is not known.
Prerequisites for induction of labour
1.Indication for induction of labour.
2.Cervix must be assessed for Bishop’s score
3.pelvis to be assessed for CPD/FPD
4.Estimated weight of the baby
5.Fetal presentation
6.Fetal well being
25
Predictors of successful induction
1.Gestational age
2.Pelvic configuration
3.Multiparity
4.EFW<3.5 kg
5.Normal BMI
6.Favourable Bishop’s score
7.Tall stature
The etiology of post term gestation is not clearly understood.
Some of the risk factors for post term pregnancy are
1. Previous post term pregnancy,
2. Nulliparity,
3. Maternal age > 30 years,
4. Obesity[25,26]
In certain rare conditions genetic predisposition to postterm pregnancy
has been reported[27,28,29] .In 49% woman who was born postterm has
26 increased risk of giving birth to a child beyond 42 weeks' gestation; the risk is 23% if the father of the child was born postterm[28].Some of the rare causes are Fetal anencephaly and placental surfactant deficiency[30].
Sometimes inappropriate clinical dating may lead to the misdiagnosis of late-term or postterm pregnancy.[30,31] EDD calculation using the last menstrual period, which assumes accurate recall and ovulation at day 14, can overestimate gestational age.[32] Early USG can reduce this miscalculation and thereby decreasing inductions for miscalculated late-term and postterm pregnancies.
Although first-trimester measurement of crown-rump length is the most accurate dating method and is often performed[30]
The American College of Obstetricians and Gynecologists states that the estimated date of delivery can be calculated from the last menstrual period if the patient has regular, normal menstrual cycles and has not taken oral contraceptives in the three months before the last menstrual period[30] However, first-trimester ultrasonography is recommended for accurate dating based on the last LMP. A post-term or prolonged pregnancy according to World Health Organization (WHO) is one that has exceeded 294 days from the last normal menstrual period.
A prolonged pregnancy can lead to post-maturity of the fetus posing a great threat to its further survival in-utero and multiple complications
27 including neonatal mortality post delivery. World-wide 5-10% of all pregnancies are prolonged with 20% of post-term fetuses having dysmaturity syndrome. The incidence of induction is on the rise, half of which are due to post-dates. At Kenyatta National Hospital the rate of induction of labour due to prolonged pregnancies stands at 50 % of all inductions. The failure of induction world-wide has been increasing and it is therefore important to determine some of the predictors of successful induction. Several studies have been done world-wide to predict factors influencing failed induction but there has been none specifically for predictors of successful induction in post-dates.
Post-term or prolonged pregnancy is when the pregnancy has exceeded the expected date of delivery by 2 weeks or more [33]. World- wide about 5-10% of pregnancies are prolonged [34]. Such pregnancies are at an increased risk of utero-placental insufficiency and macrosomia of the fetus which may lead to other fetal and maternal complications [35] and thus the need to deliver them.
In this study induction of post-dated pregnancies is done at 41 weeks as per the national guidelines, the WHO, American College of
Obstetrics and Gynaecology (ACOG) and the Royal College of
Obstetricians and Gynaecologists(RCOG) guidelines [33, 36,37,38]. The policy of inducing labour at 41 weeks (288 days of gestation) in
28 uncomplicated pregnancies is justified because when the gestational age is more than 41 weeks, the incidence of meconium staining of amniotic fluid and evidence of utero-placental insufficiency increases significantly
[39,40]. In addition, labour induction at 41 weeks’ gestation for otherwise uncomplicated singleton pregnancies reduces caesarean delivery rates without compromising perinatal outcomes [39,41] A number of key morbidities are greater in infants born to pregnancies that progress to and beyond 41 weeks gestation including meconium aspiration, neonatal academia, low Apgar scores, macrosomia, and, in turn, birth injury[42,43]. Such complications associated with fetal macrosomia include prolonged labor, cephalo-pelvic disproportion, and shoulder dystocia with resultant risks of orthopaedic or neurologic injury [42].
Approximately 20% of post-term fetuses have fetal dysmaturity
(post-maturity) syndrome, which describes infants with characteristics of chronic intrauterine growth restriction from utero-placental insufficiency
[44,45]. These pregnancies are at increased risk of umbilical cord compression from oligohydramnios, non-reassuring fetal status
(antepartum or intrapartum), intrauterine passage of meconium, and short-term neonatal complications such as hypoglycaemia, seizures, and respiratory insufficiency.[44,45]
29
Post-term pregnancy is also an independent risk factor for neonatal encephalopathy and for death in the first year of life [46]. Perinatal mortality (defined as stillbirths plus early neonatal deaths) at 42 weeks of gestation is twice that at 40 weeks (4-7 vs. 2-3 per 1,000 deliveries, respectively) and increases 4-fold at 43 weeks and 5- to 7-fold at 44 weeks [46,47]
Prolonged pregnancy is known to be associated with significantly increased risks of perinatal and maternal complications [48]
30
CHART 1 - FLOW CHART FOR MANAGEMENT OF POST
DATED PREGNANCY
31
The pre-induction cervical status is known to be the most effective of all parameters in accounting for successful induction [49,50]. Bishop established the relationship between cervical ripeness and entering spontaneous labour about fifty years ago [50].
The modified Bishop score is now being used to assess the cervix.
This system tabulates a score based upon the station of the presenting part and four characteristics of the cervix: dilatation, cervical length (instead of effacement in the original scoring system by Bishop), consistency, and position. A score that exceeds 8 describes the patient most likely to achieve a successful vaginal birth without cervical ripening [51]. Bishop scores of less than 6 usually require that a cervical ripening method be used before other methods [51]
32
TABLE 1 - MODIFIED BISHOP’S SCORE
Score <6 –unfavourable, Score >6 - favourable
The relationship between a low Bishop score and failed induction, prolonged labour, and a high caesarean birth rate was first described prior to widespread use of cervical ripening agents [52].
If the cervix is unfavourable cervical ripening should be done for successful induction
Cervical ripening is a complex process that results in physical softening and distensibility of the cervix, leading to cervical effacement and dilatation. Remodelling of the cervix involves enzymatic dissolution.
33
METHODS USED FOR CERVICAL RIPENING
There are 3 methods used for pre induction cervical ripening
They are
1. Surgical methods
-sweeping/stripping of membranes
-amniotomy or artificial rupture of membranes(ARM)
2. Pharmacological methods
3. Mechanical methods
SWEEPING OF THE MEMBRANES
It can be done as an outpatient procedure
Procedure -finger is inserted in between the membrane and cervix, then fingers swept in 360 degree causes release of prostaglandins(PGF2 alpha) which causes cervix to dilate most effective in multigravida
34
IMAGE :7 – SWEEPING OF MEMBRANE
The main aim is to initiate labour and improve the favourability of cervix by increasing the local production of prostaglandins.[53]
It is an effective mean of induction in uncomplicated term pregnancy, but less efficient than other methods such as the use of oxytocin, prostaglandins and amniotomy [54,55]. This procedure is a conservative and a non invasive approach, which could be performed in the situations where the indication to induce labor is not immediate or urgent for intervention. Therefore, membrane sweeping may hasten the
35 onset of labor and reduces the number of pregnant women continuing beyond 41 weeks and the need for formal labor induction.
Contraindications:
They are 1.Multiple gestation,
2. Placenta previa,
3. Placental abruption,
4. History of preterm delivery,
5. Vasa previa,
6. Active cervical infection,
7. Mullerian anomalies,
8.severe fetal anomalies and active herpes infection.
A recent Cochrane review showed that routine use of membrane sweeping from 38 weeks onwards does not found to have clinically important benefits [56]. The efficacy of membrane sweeping is found to be low at an earlier gestational age, and the major concern are pregnancies that extending beyond 41 weeks of gestation with unfavorable cervix [56,58]; de Miranda et al [57] noted that the Cochrane
36 review included studies with relatively small sizes, and heterogeneity between the trial results outcome.
AMNIOTOMY
It is a procedure done to release fluid from the amniotic sac to induce labor during childbirth. It is usually performed in a labor or delivery room wherein the obstetrician punctures the amniotic membrane using special instrument.
IMAGE :8 - AMNIOTOMY
37
INDICATIONS
Induction of labour
For monitoring the health status of fetus(fetal distress) during labour /childbirth
Augmentation of labour
CONTRAINDICATIONS
Placenta praevia[59]
Cephalopelvic disproportion
Abnormal position of the fetus
Active genital herpes infection
Previous classical caesarean section
PROCEDURE
1. First to determine the position and presentation of the fetus
2. Patient should be put on electronic fetal monitoring
3. For this procedure to be effective fetal head should apply sufficient pressure on the cervix.
38
4. Ask the patient to lie down in dorsal position in labour room, insert a vaginal speculum, amniotomy was done by using amniotomy hook or amni hook in between the uterine contractions
5. After the rupture one hand is placed in the vagina to let the fluid come out in a controlled manner thereby preventing cord prolapse.
Colour and consistency of the liquor was noted.
6. Check the fetal heart rate for one full minute before and after procedure to rule out any fetal distress.
COMPLICATIONS
Cord prolapse
Ruptured vasa praevia
Cord compression
Fetal scalp injury with blood loss
Infection
Chorioamnionitis
After the procedure got over labour can be augmented with oxytocin depends upon the progress of labour.[59,60]
39
PHARMACOLOGIGAL METHODS
The drugs used for cervical ripening and induction are
1. Prostaglandins – most commonly used
2. Mifepristone- now under many trials
3. Oxytocin –was used for ripening of cervix in the past, nowadays its usage for augmentation is increased rather than ripening.
4. Relaxin
5. Hyaluronidase
6. Nitric oxide donors
- Glyceryl trinitrite
- Isosorbide mononitrate
PROSTAGLANDINS
Prostaglandins are most commonly used for cervical ripening in an unscarred uterus. Prostaglandins not only improve the cervical score but also cause ripening and initiate labour. Thus the need for oxytocin to induce or augment labor is reduced.
40
The commonly used prostaglandins are
1.PROSTAGLANDIN E1(MISOPROSTOL)
SYNTHESIS OF PROSTAGLANDINS:
They are mainly synthesized from phospholipids by the enzyme phospholipase A2.The flow chart was shown below
IMAGE 9
SYNTHESIS OF PROSTAGLANDINS
41
It was first discovered by SEARL in 1973 for treating peptic ulcer patients and its effect on pregnant uterus was a major side effect. As time goes on it’s effect on termination of pregnancy and induction of labour has overcome it’s therapeutic value.
DOSAGE:
Vaginal route: 25 microgram of misoprostol in the posterior fornix-repeated every 3-6 hours until adequate uterine contractions
[61,62]
Oral route: 50 microgram once in every 3-6 hours Interval of about
4 hours should be there after the last dose before oxytocin is started.
The side effects are
Nausea
Vomitting
Diarrhoea
Tachysystole
Hyperstimulation.
42
2.PROSTAGLANDIN E2 (DINOPROSTONE)
It induces cervical ripening.
Reduces failed induction rate and the need for oxytocin.
Shortens the induction –delivery interval.
IMAGE 10
MECHANISM OF ACTION OF PG E2
43
ROUTE OF ADMINISTRATION
Intracervical –is in the form of preloaded syringe(2.5 ml) with plastic insertor which contains 0.5 mg of PG E2-cervical insertion every 6 hrs maximum of 3 doses in 24 hours interval.[63]
Intravaginal- is in the form of vaginal insert contains 10 mg of
PGE2-easily removed in cases of tachysystole/hyperstimulation.
IMAGE 11
INTRACERVICAL APPLICATION OF PG E2 GEL
44
In a study comparing group A having prostaglandin E1 with group B having prostaglandin E2 with oxytocin showed the mean induction delivery interval was reduced in group A than group B. A group showed higher number of successful vaginal deliveries(82%) than
B(77%).Tachysystole was more common in A group (20%) than
B(5%)[64].
MIFEPRISTONE{RU 486}
The use of Mifepristone provides an interesting new alternative to classic uterotonic agents for induction of labour. The potential advantages of Mifepristone over prostaglandins or oxytocin requires further evaluation.
Mifepristone is classified as an anti progestin and binds to the progestin receptor without activating it.[65].It is structurally similar to norethindrone(progestin),it binds to the progesterone receptor with affinity equal to or greater than progesterone[66].
Synonym: RU-486; RU-38486; ZK-98296
45
IMAGE 12
STRUCTURAL FORMULA OF MIFEPRISTONE
11β-[p-(Dimethyla; mino)phenyl]-17α-(1-propynyl)estra-4,9- dien-
17β-ol-3-one dien-17β-ol-3-one
46
IMAGE 13
THREE DIMENSIONAL STRUCTURE OF MIFEPRISTONE
Pregnancy category: X
Route of administration: oral
Drug class: anti progestogen,anti-glucocorticoid.
PHARMACOKINETICS
Bio availability:69%
Protein binding:98%
Metabolism:Liver catalysed by CYP3A4 enzyme
Excretion:feces and urine
47
IMAGE 14
MECHANISM OF ACTION OF MIFEPRISTONE
48
INDICATIONS
1. First and second trimester abortion
2. For emergency contraception at low doses
3. Fibroid uterus-in relief from bleeding and improving quality
of life.
4. Cervical ripening and induction of labour-many trials
supporting the evidence for its use.
5. For treating hyperglycemia secondary to cushing’s
syndrome.
DRUG INTERACTIONS:
Enzyme inhibitors:increases the drug level
Itraconazole/ketoconazole
Erythromycin macrolide
Grapefruit juice
Enzyme inducers:decreases drug level
Carbamazepine/phenytoin/phenobarbitone
Rifampin
49
Dexamethasone
Aspirin-increases risk of bleeding.
Mifepristone may inhibits the liver enzymes thereby enhancing the drugs which are going to be excreted through liver.
SIDE EFFECTS
Nausea
Vomiting
Diarrhea
Dizziness
Headache
Arthralgia
Back pain
Hypokalemia
Thyroid profile abnormality
Endometrial hypertrophy
Hypoglycemia
50
Insomnia
Chest pain
Vaginal bleeding or spotting
Fever,chills,weakness
Allergic reactions: hives, dyspnoea, swelling of face, lips,tongue,throat.
Adrenal insufficiency (4%)
MECHANICAL METHOD
They are used for cervical ripening in cases with unfavourable cervix.
1. Transcervial foley’s catheter/double balloon catheter
2. Extra amniotic saline infusion..[EASI]
3. Laminaria tents..
A Foley bulb induction is a method for inducing labor. It involves inserting a Foley catheter into the cervix to help it dilate so that the baby can pass through the birth canal.
51
A Foley catheter is a long, rubber tube with an inflatable balloon
on one end that a doctor can fill with air or sterile water.
When the balloon inflates inside the cervix, it puts pressure on the cervical cells, helping it dilate and increasing the tissue's response to oxytocin and prostaglandins. Oxytocin and prostaglandins are hormones that help to promote labor.
IMAGE 15
FOLEY’S CATHETER
A Foley bulb induction is a safe procedure. There is no evidence of increased risks for infection. Serious complications for the woman and baby are also rare.
52
There are advantages and disadvantages to this approach, so people should thoroughly discuss the decision to have a Foley bulb induction with their doctor.
The benefits of using a Foley bulb induction include that it is: low-cost low-risk in most people simple to use
widely available
Side effects:
Pain
Discomfort
Prelabour of membranes
Vaginal bleeding
Infection rarely.
Procedure
The typical Foley bulb induction procedure includes the following steps:
A doctor will monitor the baby's heart rate for at least 20 minutes.
They will confirm that the baby is in a head-down (vertex) position.
The medical team will help the woman move into the lithotomy position,
53 which involves her lying on her back with her legs in special stirrups.
The doctor will clean the perineal area using a medical solution.
Using forceps, they will move the tip of the Foley catheter through the opening in the cervix. The balloon will be just beyond the cervix, but outside the amniotic sac.
They will fill the Foley balloon with about 30 milliliters of sterile water.Doctors may tape the Foley catheter to the woman's thigh to create dragging tension.
The doctor may put more sterile water into the Foley balloon to help the cervix dilate further as time goes on.The Foley balloon will usually fall out when the cervix has dilated 3 centimeters
54
IMAGE 16
CERVICAL EFFACEMENT AND DILATATION
Nasreen nor et al compared the foley’s catheter with misoprostol for labour induction .the induction to delivery interval was shortened in misoprostol induction group when compared to foley’s group and also
55 increased vaginal delivery in unripe cervix at term. With foley’s catheter incidence of uterine hyperstimulation during labour was decreased.
COOK’S DOUBLE BALLOON TRANSCERVICAL CATHETER
The Cook Cervical Ripening Balloon catheter is comprised of two silicone balloons and uniquely engineered to allow the cervix to naturally and gradually dilate prior to the induction of labor. The first of two balloons is inflated on the uterine side of the cervix; the second is then inflated in the vaginal side of the cervix.
The two balloons adapt to the contour of the cervical canal minimizing discomfort for the patient. When the catheter is removed, cervical conditions should have improved to a favorable state to allow for induction of labor and active labor management.
56
IMAGE 17
DOUBLE BALLOON CERVICAL CATHETER
57
IMAGE 18
INSERTION OF DOUBLE BALLOON CATHETER
58
3.LAMINARIA TENTS
It is a type of osmotic dilator used to dilate the cervix by swelling as they absorbs fluid from the surrounding tissue.[67].A laminaria tent or stick is a thin rod made of the stems of dried laminaria plant[68]
IMAGE 19
IMAGE OF A LAMINARIA TENTS
59
PROCEDURE
A speculum is placed in the vagina to allow visualization uterine cervix. Anterior lip of the cervix is grasped by a vulsellum to straighten the cervical canal and steady the cervix. It is performed by giving paracervical block. The dilator is then grasped with a ring forceps and is placed into the cervix spanning both the internal and external cervical os.
After sometime, the dilator absorbs fluid and swells 3 to 4 times the initial diameter.[69] this increase in size occurs within 6 hours after the dilator are placed in the cervix, then expansion will continue over 12–24 hours.[70] Depends upon the degree of cervical dilation more than one dilator can be inserted . This may be affected by the gestational age of the pregnancy and history of prior vaginal deliveries. The number of dilators increases with advancing gestational age. Laminaria tents are usually left in place overnight.[71][72]
60
IMAGE 20
INSERTION OF LAMINARIA TENT
MECHANISM OF ACTION
It acts by absorbing fluid from the surrounding tissue and expanding. Thus exerts radial pressure on the cervix. They also cause the release of prostaglandins.[73]
REMOVAL
After they have started the process of dilating the cervix it was removed prior to initiating the D&E by grasping the strings of the dilator and applying gentle traction. The cervix may be dilated further using rigid cervical dilators [74]
INDICATION
1.surgical abortion prior to D&E
61
2.cervical ripening in late pregnancy
3.gynecological procedures like hysteroscopy in non pregnant uterus
COMPLICATIONS
1. Pain during insertion
2. Rupture of membranes
3. Cervical /uterine perforation, infection due to its retention
62
MATERIALS AND METHODS
Study design - Randomised control study
Study place - Department of obstetrics and gynaecology,
Coimbatore medical college hospital
Study duration - Jan 2018 to Dec 2018
Inclusion criteria
• Post dated pregnant women
• Singleton pregnancy
• Cephalic presentation
Exclusion criteria
• Hypertension
• Diabetes mellitus
• Multiple pregnancy
• Renal disease
• Heart disease complicating pregnancy
63
• Oligohydramnios
• FGR
• Big baby
• Contracted pelvis
Sample size
200
Study design
During the period from Jan 2018 to Dec 2018,patients coming to
Obstetrics and Gynaecology department in Coimbatore medical college hospital based on the inclusion and exclusion criteria were enrolled in the study.
All patients were explained about the study and informed written consent was obtained from them in the language of convenience.
A detailed history including patient’s age, parity, socioeconomic status, menstrual, medical history, obstetric history, past history noted.
General examination, systemic and obstetric examination done.
Routine investigations like complete blood count, urine routine, blood grouping,,HIV, HbsAg, VDRL, Blood sugar and Ultrasound was done.
64
Study population were randomized into two groups. One group of patients were treated with Tab. Mifepristone 200 mg orally. Another group treated with foley’s catheter for induction of labor.
The following results were observed after 24 hours
1.change in the bishop’s score
2.mode of delivery
3.induction delivery interval
4.neonatal outcome
5.incidence of PPH
Based upon the results, need for further augmentation by either prostaglandin gel induction or amniotomy or oxytocin acceleration was taken into consideration for safe delivery.
65
OBSERVATION AND RESULTS
The following pages are the tables and graphs which gives us the descriptive analysis of 200 patients in the study according to the distribution, age, parity, mode of delivery, induction -delivery interval, neonatal outcome, amount of blood loss.
TABLE 2
DISTRIBUTION OF STUDY PARTICIPANTS
Induction types Frequency Percentage (%)
MIFEPRISTONE 100 50.0
FOLEY 100 50.0
Total 200 100.0
In this study,100 patients were induced with mifepristone, another
100 patients were induced with foley’s catheter
66
CHART 2
DISTRIBUTION OF STUDY PARTICIPANTS
Distribution of study participants
MIFEPRISTONE 50% 50% FOLEY
67
TABLE 3
MEAN AGE OF THE STUDY GROUP
Induction types N Mean SD P value
MIFEPRISTONE 100 24.54 3.940 AGE .356
FOLEY 100 25.01 3.211
A total of 200 patients were included in the study.The mean age of the patients taking part in this study was around 24-25 years.
CHART 3
MEAN AGE OF THE STUDY GROUP
Mean age
25.01 25.1
25
24.9
24.8
24.7 24.54
24.6
24.5
24.4
24.3 MIFEPRISTONE FOLEY
68
TABLE 4
ASSOCIATION OF PARITY WITH TYPE OF INDUCTION
PARITY INDUCTION
P value MIFEPRISTONE FOLEY
Primi gravida 63(46.7%) 72(53.3%) .174 Multi gravida 37(56.9%) 28(43.1%)
In this study out of 200 patients,100 patients were induced with
tab.mifepristone and 100 patients were induced wth foley’s catheter.
In mifepristone group out of 100, 46.7% was primigravida and
56.9% was multigravida.
In foley’s catheter group,out of 100,53.3% was primigravida and
43.1% was multigravida
69
CHART 4
ASSOCIATION OF PARITY WITH TYPE OF INDUCTION
Association of Parity with type of Induction
80 72 70 63 60 50 37 MIFEPRISTONE 40 28 FOLEY 30 20 10 0 Primi gravida Multi gravida
70
TABLE 5
ASSOCIATION OF MODE OF DELIVERY WITH TYPE OF INDUCTION
TYPE OF MODE OF DELIVERY
INDUCTION P value LABOUR LSCS NATURAL
MIFEPRISTONE 84(84.0%) 16(16.0%) .005* FOLEY 67(67.0%) 33(33.0%)
*-P is <0.05 and found to be Statistically Significant
In this study ,association of mode of delivery with the type of induction was studied.In mifepristone group,84 % of patients deliver by labour natural compared to 67% in foley catheter group. The rate of caesarean section rate was only 16% in mifepristone group than compared to foley group which was 33%.This reduction in the rate of caesarean section among the two groups were found to be significant(p value<0.05).
71
CHART 5
ASSOCIATION OF MODE OF DELIVERY WITH TYPE OF INDUCTION
Association of Mode of delivery with Type of Induction
84 90 80 67 70 60 Labour natural 50 LSCS 40 33 30 16 20 10 0 MIFEPRISTONE FOLEY
72
TABLE 6
ASSOCIATION OF DURATION OF DELIVERY WITH TYPE OF INDUCTION
INDUCTION N MEAN SD TYPES P value
100 26.85 8.169 INDUCTION MIFEPRISTONE .000* -DELIVERY INTERVAL IN HRS 100 36.01 6.118 FOLEY
*-P is <0.05 and found to be Statistically Significant
This study showed that there was a significant reduction in induction – delivery interval in mifepristone group compared to foley’s catheter group.The mean induction to delivery interval was 26 hours as compared to 36 hours in foley’s induction group. This decrease in interval between the two groups was found to be significant(p value :
<0.05)
73
CHART 6
ASSOCIATION OF DURATION OF DELIVERY WITH TYPE OF INDUCTION
Association of duration of delivery with Type of Induction
36.01 40 35 26.85 30 25 20 15 10 5 0 MIFEPRISTONE FOLEY
74
TABLE 7 ASSOCIATION OF NEONATAL OUTCOME WITH TYPE OF INDUCTION
NEONATAL OUTCOME
INDUCTION TYPES WELL MSAF/VIGOROUS RDS BABY P value
MIFEPRISTONE 9(9.0%) 3(16.0%) 88(88.0%) .028* FOLEY 13(13.0%) 12(12.0%) 75(75.0%)
*-P is <0.05 and found to be Statistically Significant
This study compared the incidence of meconium stained liquor and respiratory distress in newborn born in the study group.
The incidence of meconium stained liquor was 9% in mifepristone group when compared to 13% in the foley’s group. All the babies born with meconium stained liquor are vigorous only.
This decline in the incidence of respiratory distress in newborn was found to be statistically significant (p value: < 0.05%)
75
CHART 7
ASSOCIATION OF NEONATAL OUTCOME WITH TYPE OF INDUCTION
Association of Neonatal outcome with type of Induction
88 90 75 80
70
60
50 MIFEPRISTONE
40 FOLEY
30
20 13 12 9 10 3
0 MSAF/VIGOROUS RDS WELL BABY
76
TABLE 8
ASSOCIATION OF BLOOD LOSS WITH TYPE OF INDUCTION
INDUCTION MODE OF DELIVERY TYPES P value Nil Yes
MIFEPRISTONE 0(0.0%) 100(100.0%) .316 FOLEY 1(1.0%) 99(99.0%)
In this study the incidence of PPH was compared between the two groups which was found to be insignificant as the P value >0.05.
77
CHART 8
ASSOCIATION OF BLOOD LOSS WITH TYPE OF INDUCTION
Association of Blood loss with type of Induction
100 99 100
90
80
70
60 Yes 50 No
40
30
20
10 0 1 0 MIFEPRISTONE FOLEY
78
DISCUSSION
This observational randomized study was conducted in the
Coimbatore medical college hospital among 200 post dated pregnant mothers planning for induction of labour. There are various methods used for induction of labor. In this study we compare the efficacy of
Tab,Mifepristone with Foley’s catheter for induction of labor. Response to the induction were observed by using various parameters.
Among the 200 patients in the study,100 women were induced with Tab. Mifepristone and another 100 women were treated with Foley’s catheter. In the study group, 135 women are Primigravida and 65 women are multigravida.
The mean age for the women in the study group were in between
24 -25 yrs. There was significant improvement in bishop’s score in the study groups which showed similarities with the studies conducted by
Atawale et al, Fathima et al and Dr.Gautam Aher
The mode of delivery in the women who were enrolled in the study was found to be significant as 84% of patient in mifepristone group delivered vaginally compared to 64% in foley’s induction group.16% patients were undergone caesarean section in mifepristone group as compared to 33% in the foley’s induction group. Similar results were
79 observed in studies conducted by Lata G et al, Rutuja at hawale, Wing
DA.
The mean duration of induction –delivery interval was found to be
26 hours in mifepristone group compared to 36 hours in foley’s group.This was in accordance with study conducted by Kannan Yelikar.
The incidence of respiratory distress in mifepristone group was found to be 3% compared to 12% in foley’s group. There was no significant changes in perinatal outcome as observed in studies conducted by Hapangama and Byrne et al. The incidence of PPH observed in the study was found to be insignificant.
The use of Mifepristone in induction of labor in post dated pregnancy have shown significant reduction in caesarean section rates, shortens the induction –delivery interval, reduction in the incidence of respiratory distress.
80
SUMMARY
A comparative study to assess the efficacy of Mifepristone with
Foley’s catheter for induction of labor in post dated pregnancies was done in patients admitted in Department of Obstetrics and Gynaecology of a tertiary care centre from Jan 2018 to Dec 2019.A thorough history,LMP, systemic and obstetric examination and basic blood investigations and ultrasound was done. Patients were randomly allocated into two groups.
One treated with Oral Mifepristone 200 mg and another group with
Foley’s catheter. Various parameters were observed after 24 hours of induction.
Our study included 200 patients out of which 100 were given
mifepristone and another 100 were given foley’s catheter.
135 women are primigravida and 65 women were multigravida.
The mean group of the patients in this study were in the range of
24-25 years.
84% of patient in mifepristone group delivered vaginally
compared to 64% in foley’s induction group.16% patients were
undergone caesarean section in mifepristone group as compared to
33% in the foley’s induction group.
81
The mean induction –delivery interval was found to be 26 hours
in mifepristone group compared to 36 hours in foley’s group.
The incidence of respiratory distress in mifepristone group was
found to be 3% compared to 12% in foley’s group. Majority of
studies showed that there was no significant perinatal morbidity
and mortality in using this drug.
82
CONCLUSION
Based on the observations made in our study we recommend the following:
• Mifepristone can be used as an inducing agent in post dated
pregnancy due to it’s effect on induction –delivery interval,
mode of delivery, neonatal outcome.
• No significant results were observed in incidence of PPH in
both groups.
• The incidence of meconium stained liquor with fetal distress
needs further follow up with the study.
• Further trials for the use of Mifepristone in inducing labor in
post dated pregnancy and it’s effect in causing tachysystole
and hyperstimulation during induction.
Limitations of the study:
1. The study period and sample size was limited and thus the
results obtained may lack precision.
2. No control group were included in the study.
83
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PROFORMA
Name : Age : Address :
Occupation :
Booked and immunized:
LMP: EDD:
Chief Complaints:
● H/O amenorrhoea ● Able to perceive fetal movements ● Any H/o bleeding /draining PV ● Any signs and symptoms of PIH,fever,urinary tract infection ● Menstrual H/O:
Marital H/O :
Past H/O :
Personal H/O :
Family H/O :
General Physical Examinaton:
Built and Nourishment
Anemia / Cyanosis / clubbing / Icterus / Pedal edema / generalised lymphadenopathy
Breast ,Thyroid ,Spine examination
Height: Weight: BMI:
Vitals
● BP : ● PR :
98
● RR :
Systemic Examination:
● CVS : ● RS : ● CNS : ● Abdomen examination Inspection Palpation Auscultation Per vaginal examination INVESTIGATION
Complete Hemogram :
● Blood Sugar :
● RFT :
● LFT :
● Urine routine :
● USG Obstetrics :
99
CONSENT FORM
I Mrs______hereby volunteer to participate in the study ”A RANDOMIZED COMPARATIVE STUDY OF
MIFEPRISTONE WITH FOLEY’S CATHETER FOR
INDUCTION OF LABOUR IN POST DATED PREGNANCY”. I was fully explained about the nature of the study by the doctor, knowing which I fully give my consent to participate in this study
Date:
Place:
Signature of the patient / guardian
100
ஒ த ப வ
ெபய :
வய :
பா ன :