Patient Group Direction

PGD for the administration of: PGD Ref: PGD101 Dinoprostone (Propess ®) pessary Effective from: December 2020 by Registered Midwives in Maternity. Expiry: December 2022

Originator: Christine Harding, Consultant Midwife Signed: Professional Qualification: RM 87J1882E Date:

Place of Work: Maternity This Patient Group Direction has been approved by:

Name: Signature: Date: Senior Doctor participating in the PGD development

Name: S Stirling Signature: Date: Lead Pharmacist for Maternity

Name: N/A Signature: Date: Microbiologist (required for PGD’s written for antimicrobials)

Name: Signature: Date: On behalf of the Medicines Management Committee

PGD: Dinoprostone (Propess ®) pessary, December 2020 1 of 7 Patient Group Direction PGD Ref: PGD101

Direction for the administration of: Dinoprostone 10mg (Propess®) pessary

Purpose of the treatment: To induce labour

Indication for use, if medicine is ‘black triangle’ or used outside N/A of its licensed use (see development guidelines) Listed in ‘Medicines for N/A Children’ Ward or Department to which the Maternity PGD applies:

Clinical condition

Clinical condition / situation: Induction of labour (IOL) in term pregnancies in the IOL suite

Pregnancy equal to or greater than 38 weeks’ gestation Indications for IOL where a midwife can administer Propess include:  Post-dates pregnancies**  Immediate induction for term pre-labour rupture of membranes**  Reduced fetal movements  Gestational diabetes/diabetes  Pregnancy Induced Hypertension and/or PET  Reduced liquor volume  Obstetric Cholestasis Inclusion Criteria: In the presence of the following clinical findings:  Normal maternal observations  Engaged, Cephalic presentation.  Normal CTG prior to administration.  Unfavourable cervix with a Bishop’s score <6 and intact membranes (except PROM indication).  Not in labour. **decision for induction for these indications can be made by a midwife. Decision for IOL for all other indications has to be made by an Obstetrician. IOL for any other indication not listed above, Propess has to be prescribed by an Obstetrician  Placenta praevia or unexplained vaginal bleeding  Fetal malpresentation and/or distress Exclusion Criteria:  Previous Caesarean Section  Woman declines treatment

PGD: Dinoprostone (Propess®) pessary PGD101 2 of 7 Patient Group Direction PGD Ref: PGD101

 Spontaneous onset of labour  Preterm pregnancy  Unengaged cephalic presentation  Current pelvic inflammatory disease  Hypersensitivity

Action if patient excluded: Refer for obstetric opinion

Action if patient declines Refer to Obstetrician treatment

Staff criteria

Professional qualifications Registered Midwife required: Specialist/additional Midwives must be able to administer Propess qualifications, experience or

training required: All midwives undertaking induction of labour will undergo training with a representative from the Pharmaceutical company or Requirements for continuing midwife already competent in Propess administration. The training and education: training will include discussion on technique and having your first attempt witnessed by the training midwife.

Treatment

Name: Dinoprostone Name, strength and Form: Vaginal pessary formulation of medicine: Strength: N/A Dose/dose 10mg range Route: Vaginal

Legal status of medicine: POM

The Propess pessary should be inserted high into the posterior fornix of the cervix and rotated into a transverse position. The fingers should be removed carefully so that the tape unravels towards the vulva. Most of the tape should be placed in the lower part of the vagina to prevent the Details of woman accidentally pulling the Propess out, particularly when using the administration/special lavatory, or showering. The withdrawal tape may be cut with scissors as instructions: long as there is sufficient tape outside the vagina to allow removal. Not attempt should be made to tuck the end of the tape inside the vagina. The woman should remain lying down for 30 minutes following administration.

PGD: Dinoprostone (Propess®) pessary PGD101 3 of 7 Patient Group Direction PGD Ref: PGD101

Minimum and maximum total doses: 10mg

Once only on first administration or in the event the pessary falls out Frequency of within 24 hours of administration of first dose – reinsert the same pessary administration : or use a new one if appropriate. Remove Propess when in established labour i.e. regular contractions and cervix is dilated >3cm. Maximum and minimum If labour does not commence within 24 hours, remove Propess and offer treatment periods: woman a repeat vaginal examination for suitability for artificial rupture of membranes. Refer for obstetric review if ARM not possible. Follow up actions After administration monitor maternal and fetal wellbeing as outlined in required: Induction of Labour guideline Written and verbal advice given to patients Written and verbal information prior and post administration of Propess. Pre or post treatment: Contra-indications:  Active cardiac or pulmonary disease  Placenta praevia or unexplained vaginal bleeding  Ruptured membranes  Major cephalopelvic disproportion or fetal malpresentation  Untreated pelvic infection  Fetal distress  Grand multiparas and multiple pregnancy  History of caesarean section  History of difficult or traumatic delivery Relevant warnings,  Avoid extra-amniotic route in cervicitis or vaginitis including potential adverse Cautions: reactions/contra-  History of severe asthma indications:  Glaucoma and raised intra-ocular pressure Identification and  Hypertension management of adverse  History of epilepsy reactions:  Uterine scaring or rupture  Risk factors for intravascular coagulation  Effect of oxytocin enhanced  Multiple pregnancy  Three or more full term deliveries previously  Women > 35 years  Women with pregnancy complications  Women at >40 weeks’ gestation

Side effects:  Nausea and vomiting

PGD: Dinoprostone (Propess®) pessary PGD101 4 of 7 Patient Group Direction PGD Ref: PGD101

 Abdominal Pain  Headache  Diarrhoea  Uterine hyper tonus  Severe uterine contractions  Pulmonary or amniotic fluid embolism  Meconium in amniotic fluid  Abruption placenta  Fetal distress  Neonatal hypotension  Neonatal hyper bilirubinaemia  Pruritis  Genital oedema  Rapid cervical dilation  Fever  Uterine hyper contractility with or without fetal bradycardia  Low Apgar scores  Neonatal respiratory distress  Uterine rupture  Vaginal symptoms (warmth, irritation, pain)  Disseminated Intravascular Coagulation  Still birth or neonatal death  Postpartum haemorrhage  Abnormal labour Increased contractions may or may not cause fetal distress - Commence CTG at onset of regular contractions. Anaphylactic reaction is estimated in 1:10,000 women, this includes difficult breathing, rapid or weak pulse, dizziness, skin redness. If anaphylaxis is suspected: remove Propess, seek urgent obstetric/anaesthetic help and follow anaphylaxis algorithm. Circumstances in which Fetal distress further advice should be Hyperstimulation of the uterus sought from a Doctor and arrangements for referral: Second dose of Propess required

Reporting procedure of Online reporting system adverse reactions / Maternal records incidents:

*Key POM Prescription only P Pharmacy only GSL General Sales List L Licensed OL Used outside of licence BT Black Triangle

PGD: Dinoprostone (Propess®) pessary PGD101 5 of 7

Patient Group Direction PGD Ref: PGD101

Patient Group Direction for the administration of: Dinoprostone (Propess®) pessary Ref No: PGD101 Expiry Date: December 2022 Department: Maternity

The following Staff members are authorised to administer medication under this Patient Group Direction having been assessed as competent to do so. Professional Name Date Signature Managers Signature Status

PGD: Dinoprostone (Propess®) pessary PGD101, December 2020 6 of 7

Patient Group Direction PGD Ref: PGD101 Patient Group Direction for the administration of: Prostin® E2 vaginal gel Ref No: PGD100 Expiry Date: December 2022 Department: Maternity

Record of Administration

Patient Details Medication Details Date Time Signature Name, Address, DOB, Hospital No. Name, Dose, Route, Batch, Expiry Date of person supplying and administering

PGD: Dinoprostone (Propess®) pessary PGD101, December 2020 7 of 7