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OpenTrials
Completed

NCT Number: NCT04731896

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

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.

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Key information

Conditions

Labor, Induced Amniotomy

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Mongi Slim la Marsa

Tunis, La Marsa, 2046, Tunisia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotomy

Procedure

artificial rupture of the amniotic sac

Primary outcomes

  1. Time to active phase of labor

    Time frame: At delivery

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

Secondary outcomes

  1. Cesarean delivery rate

    Time frame: At delivery

    Rate of cesarean section

  2. Time to vaginal delivery

    Time frame: At delivery

    Total time from initiation of labor induction to vaginal delivery

  3. Maternal outcomes

    Time frame: From inclusion to discharge, up to 2 weeks

    Intrapartum and postpartum fever, postpartum haemorrhage, chorioamnionitis, endometritis

  4. Fetal and neonatal outcome

    Time frame: From inclusion to discharge, up to 2 weeks

    Fetal distress, birth asphyxia, acidosis, sepsis

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2021
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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