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

Labor, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731896
• Other study ID #: UTuniselmanar2
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Amniotomy
• Labor, Induced

Intervention

Procedure:
• Amniotomy
artificial rupture of the amniotic sac

Locations

Country	Name	City	State
Tunisia	University hospital Mongi Slim la Marsa	Tunis	La Marsa

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to active phase of labor	Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation	At delivery
Secondary	Cesarean delivery rate	Rate of cesarean section	At delivery
Secondary	Time to vaginal delivery	Total time from initiation of labor induction to vaginal delivery	At delivery
Secondary	Maternal outcomes	Intrapartum and postpartum fever, postpartum haemorrhage, chorioamnionitis, endometritis	From inclusion to discharge, up to 2 weeks
Secondary	Fetal and neonatal outcome	Fetal distress, birth asphyxia, acidosis, sepsis	From inclusion to discharge, up to 2 weeks