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Hyoscine Butylbromide for Cervical Rigidity In logy & Ob o st ec e tr n i y c s G Tarrats et al., Gynecol Obstet (Sunnyvale) 2019, 9:3 Gynecology & Obstetrics DOI: 10.4172/2161-0932.1000500 ISSN: 2161-0932 Research Article Open Access Hyoscine Butylbromide for Cervical Rigidity in the First Stage of Labor: Randomized Clinical Trial Laura Tarrats1*, Isabel Navarri1, Isabel Paez1 and Sandra Cabrera2,3 1Obstetrics and Gynecology Service, University Hospital Germans Trias i Pujol, Badalona, Canyet Road 08916 Badalona, Barcelona, Spain 2Nursing Research, Institut Català d´Oncologia Badalona, Canyet Road 08916 Badalona, Barcelona, Spain 3Department of Fundamental, Medical and Surgical Nursing Science, University of Barcelona, Barcelona, Spain *Corresponding author: Laura Tarrats Velasco, Delivery Ward Midwife, Obstetrics and Gynecology Service, University Hospital Germans Trias I Pujol, Badalona, Canyet Road 08916 Badalona, PhD student, Autonomous University of Barcelona, Spain, Tel: 0034650721780; E-mail: [email protected] Received date: March 12, 2019; Accepted date: March 15, 2019; Published date: March 21, 2019 Copyright: © 2019 Tarrats L, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Background: Midwives and obstetricians may encounter dilations complicated by cervical rigidity, diagnosed during the periodic vaginal examinations performed during labor. Objective: To assess the effects of hyoscine butylbromide for cervical rigidity in the first stage of labor Study design: randomized, placebo-controlled, double-blind, parallel, pre-post clinical trial. Pregnant women delivering at University Hospital Germans Trias i Pujol in Badalona, Barcelona between January 2013 and January 2018 were eligible for inclusion. Our calculated sample size target was 70 participants 35 in each group with a 95% confidence level, an alfa and beta level of 5% and 80% power. The intervention group received 40 mg of hyoscine butylbromide intravenously, while controls received a placebo drip. Primary outcomes were: duration (minutes) of the first stage of labor, duration (minutes) from intervention to complete dilation and changes in cervical rigidity. We also collected data on maternal and neonatal variables. Results: Seventy-one women were included: 47 (66.2%) were nulliparous, and 35 (49.3%) had a spontaneous onset of labor. Fifty-seven (80.3%) women had vaginal deliveries: 37 (52.1%) were eutocic, 7 (9.8%) were assisted by obstetric vacuum, and 13 (18.3%) with forceps/spatulas; 14 (19.7%) were cesarean deliveries following complete dilation. Mean duration of the first stage of labor was 48.3 minutes shorter in the experimental group compared to the control (p=0.287), and mean time from intervention to complete dilation was 63.3 minutes shorter in the experimental group than control group (p=0.084). Conclusion: dilation time and duration of delivery were lower in women with cervical rigidity who receive hyoscine butylbromide, but differences were not statistically significant. Keywords: Cervix rigidity; First stage of labour; Hioscine butyl Epidural anesthesia is one of the main factors that can produce bromide; Midwives changes in the tissue characteristics of the cervix at the moment of administration [9,10]. Antispasmodic agents are sometimes used for Introduction prevention of delay in labor, despite the fact that the most recent guidelines on intrapartum care advise against these interventions [11]. In daily practice, midwives and obstetricians may encounter dilations complicated by cervical rigidity, diagnosed during the The cervix is made up of two parts, endocervix and exocervix, periodic vaginal examinations performed during labor. which have morphological and functional differences at the mucosal level, but similar stroma [12]. The decision to administer Hyoscine In a previous study of our research group at the University Hospital Butylbromide (HBB) during dilation is based on its relaxing action on Germans Trias i Pujol (HUGTiP), we observed a prevalence of cervical the smooth genital musculature. The present study aims to analyze the rigidity (defined as a non-elastic, constricted cervical ring detected effects of HBB in the presence of cervical rigidity that may slow the during active labor) in 19.2% of all observed dilations and a positive correct development of the first stage of labor (dilation) and is not due association between induced labour and cervix rigidity [1,2]. Current to previous surgery [13]. induction rates stand at approximately 20% of all labors [3,4], with an upward trend due to clinical guidelines recommending that pregnancy Materials and Methods not exceed 41 weeks of gestation [5-7]. Likewise, the appropriate identification of the beginning of the dilation stage (centered, effaced cervix, dilated at least 3 cm; regular uterine contractions, fetal head Aims engaged in the pelvis) is also related to the evolution of labor [8]. To assess the effects of Hyoscine Butylbromide (HBB) for cervical rigidity in the dilation stage of labor. Gynecol Obstet (Sunnyvale), an open access journal Volume 9 • Issue 3 • 1000500 ISSN:2161-0932 Citation: Tarrats L, Navarri I, Paez I , Cabrera S (2019) Hyoscine Butylbromide for Cervical Rigidity in the First Stage of Labor: Randomized Clinical Trial. Gynecol Obstet (Sunnyvale) 9: 500. doi:10.4172/2161-0932.1000500 Page 2 of 6 Methodology the time to dilation by at least 60 min compared to controls, and that these differences would be statistically significant. We used a double-blinded, parallel group, pre-post, randomized placebo-controlled clinical trial design. The intervention group of pregnant women received 40 mg HBB intravenously (i.v.). The study Rigour took place in the delivery ward of HUGTiP, part of the Catalan Health Participants were selected through non-probabilistic accidental Institute in Badalona (Catalonia, Spain) in 2013-2018. sampling following diagnosis of cervical rigidity during labor. Allocation to the parallel study arms was determined using sealed, Sample opaque, numbered envelopes, which each contained a color-coded card indicating group assignment. Sequence allocation employed a Inclusion, exclusion, and withdrawal criteria are summarized in computer-generated (Epidat) random number table. Table 1. A midwife not involved in following participants during dilation Inclusion Exclusion Withdrawal criteria was responsible for preparing the intervention and placebo fluid bags, which were identical in appearance, and assigning a study code to Term Detection of cervical rigidity Fetal distress during labor gestation during active labor each. Singleton Confirmed by pH testing of fetal The birth attendant was blinded to the contents of the fluid bag, as head was the participant herself. This double-blinding ensured the impartiality of the assessments. Low-medium Hypersensitivity to any C-section before complete risk component of the study drug dilation The independent variable was the administration or not of 40 mg pregnancies HBB i.v. during the dilation stage. Cephalic Fetal distress during labor The epidural catheter and/or Participants received a single dose of the drug or placebo following presentation confirmed by pH testing of fetal analgesia Up to 30 min before head or after HBB administration diagnosis of cervical rigidity. Also, the following dependent variables were defined: total duration of dilation (min), time from intervention Age 18-40 Untreated narrow-angle to complete dilation (min), and the characteristics of the cervix years old glaucoma following the intervention (elasticity/rigidity). Other variables are Detection of Tachycardia Missing data in the clinical summarized in (Tables 1 and 2). cervical record rigidity Intervention characteristics Myasthenia gravis Participants required other during active medication than oxytocic labor Upon admittance to the delivery room, the midwives responsible agents, epidural analgesia, prophylactic antibiotics for attending the women during labor gave them written and oral information about the study and invited them to participate if cervical Written Paralytic ileus rigidity were detected during the dilation stage. informed consent Mechanical bowel obstruction When cervical rigidity was detected, the diagnosis was confirmed by double examination, and the inclusion/exclusion criteria of the study Megacolon were assessed. Treatment with tricyclic Our team informed the women of the cervical rigidity and antidepressants, antihistamines, quinidine, requested their signature on the informed consent form which had amantadine, disopyramide, been distributed previously. Once we confirmed that they had not dopamine antagonists, β- received epidural anesthesia in the previous 30 min, we proceeded to adrenergic, drugs that could administer the intervention: interact with HBB 1. The experimental group received 40 mg HBB i.v, diluted in 100 Prior to cervical surgery mL of saline, over 10 min The epidural catheter and/or 2. The control group received a placebo drip (100 mL of saline) analgesia up to 30 min before or after HBB administration Both groups underwent the same procedures for diagnosis of cervical rigidity: the attending midwife detected the characteristics of Table 1: Inclusion, exclusion and withdrawal criteria. cervical rigidity and consulted another midwife or obstetrician for a second opinion. If both birth attendants concurred in assessing the
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