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

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

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.

Study Overview

• Status: Completed
• Conditions: Labor, Induced; Amniotomy
• Intervention / Treatment: Procedure: Amniotomy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • La Marsa
    • Tunis, La Marsa, Tunisia, 2046
      • University hospital Mongi Slim la Marsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Late Amniotomy; Initiating induction of labor with oxytocin infusion followed by amniotomy 4-6 hours later
ACTIVE_COMPARATOR: Early Amniotomy; Early amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later	Procedure: Amniotomy; artificial rupture of the amniotic sac

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (ACTUAL): February 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: labor; induction; Amniotomy
• Other Study ID Numbers: UTuniselmanar2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 5 years from 01/01/2022
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No