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

NCT04731896 | Completed

• 1 other identifier: UTuniselmanar2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, Induced; Amniotomy

Keywords

labor; Amniotomy; induction

Outcome Measures

Primary Outcomes (1)

• Time to active phase of labor

  Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation

  At delivery

Secondary Outcomes (4)

• Cesarean delivery rate

  At delivery

• Time to vaginal delivery

  At delivery

• Maternal outcomes

  From inclusion to discharge, up to 2 weeks

• Fetal and neonatal outcome

  From inclusion to discharge, up to 2 weeks

Study Arms (2)

Late Amniotomy

NO INTERVENTION

Initiating induction of labor with oxytocin infusion followed by amniotomy 4-6 hours later

Early Amniotomy

ACTIVE COMPARATOR

Early amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later

Procedure: Amniotomy

Interventions

Amniotomy PROCEDURE

artificial rupture of the amniotic sac

Early Amniotomy

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years old
• Full term (36 weeks and 3 days of gestation reached)
• Singletion gestation in cephalic presentation
• Bishop score of ≥ 6

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

University hospital Mongi Slim la Marsa

Tunis, La Marsa, 2046, Tunisia

Location

MeSH Terms

Interventions

Amniotomy

Intervention Hierarchy (Ancestors)

Labor, Induced; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: February 8, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years from 01/01/2022

Locations

TU (1)