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

Not Applicable

Completed

• Conditions: Amniotomy; Labor, Induced
• Interventions: Procedure: Amniotomy

• Registration Number: NCT04731896
• Lead Sponsor: University Tunis El Manar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Study Start: 2021-02-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Amniotomy	Amniotomy	Early amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later

Primary Outcome Measures

Name	Time	Method
Time to active phase of labor	At delivery	Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University hospital Mongi Slim la Marsa; 🇹🇳 Tunis, La Marsa, Tunisia