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

University Tunis El Manar

Status: Completed

Conditions: Labor, Induced; Amniotomy

Treatments: Procedure: Amniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04731896

UTuniselmanar2

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Late Amniotomy

No Intervention group

Description:

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

Early Amniotomy

Active Comparator group

Description:

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

Treatment:

Procedure: Amniotomy