Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6

Study Overview
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Brief Summary
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Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth. A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health. Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown. The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.

Official Title
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Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 : a Randomized Trial

Conditions
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Labor, Induced, Amniotomy

Intervention / Treatment
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* Procedure: Amniotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Full term (36 weeks and 3 days of gestation reached) Singletion gestation in cephalic presentation Bishop score of ≥ 6 Exclusion Criteria: Prior uterine surgery, previous cesarean section Ruptured membranes Spontaneous labor Multifetal pregnancy Dystocic presentation Fetal head not fixed at pelvic brim Macrosomia Hydramnios Severe fetal growth restriction Major fetal anomaly Women with HIV, hepatitis C, hepatitis B Women with medical conditions contraindication to a vaginal delivery Women with COVID-19 infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Late Amniotomy<br>Initiating induction of labor with oxytocin infusion followed by amniotomy 4-6 hours later | |
| Active Comparator: Early Amniotomy<br>Early amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later | Procedure: Amniotomy<br>* artificial rupture of the amniotic sac<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to active phase of labor | Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery rate | Rate of cesarean section | At delivery | 
| Time to vaginal delivery | Total time from initiation of labor induction to vaginal delivery | At delivery | 
| Maternal outcomes | Intrapartum and postpartum fever, postpartum haemorrhage, chorioamnionitis, endometritis | From inclusion to discharge, up to 2 weeks | 
| Fetal and neonatal outcome | Fetal distress, birth asphyxia, acidosis, sepsis | From inclusion to discharge, up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor, Amniotomy, induction