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

NCT ID: NCT04731896

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Late Amniotomy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Early Amniotomy

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

Group Type: ACTIVE_COMPARATOR

Amniotomy

Intervention Type: PROCEDURE

artificial rupture of the amniotic sac

Interventions

Amniotomy

artificial rupture of the amniotic sac

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Halouani

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University hospital Mongi Slim la Marsa

Tunis, La Marsa, Tunisia

Countries

Tunisia

Other Identifiers

UTuniselmanar2

Identifier Type: -

Identifier Source: org_study_id