Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol

Labour Induction Clinical Trial

— RCT  

Official title:

Early Versus Late Amniotomy on Labour Induction in Nulliparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514770
• Other study ID #: 11/2019 OBSGN 27
• Status: Completed
• Phase: N/A
• Start date: May 3, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: August 2020
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.

Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable

Description:

study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 20, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Pregnant women at 36 weeks gestation or more

2. Nullipara

3. singleton fetus

4. cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.

Exclusion Criteria:

1. Macrocosmic babies with estimated fetal weight of more than 4000 gram

2. Previous uterine scars

3. Pre labor premature rupture of fetal membranes

4. Polyhydramnios.

Related Conditions & MeSH terms

• Labour Induction

Intervention

Drug:
• Misoprostol
rupture of membrane early and late

Locations

Country	Name	City	State
Egypt	Menoufia University hospital	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful induction	definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction	immediately after intervention
Primary	induction-delivery interval	duration of labor and amniotomy delivery interval	immediately after intervention
Secondary	misoprostol doses administered	number of misoprostol doses administered	during the intervention
Secondary	the need for augmentation of labor	the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor	during the intervention
Secondary	intrapartum meconium	intrapartum meconium passage	during the intervention
Secondary	Apgar score	Apgar score less than 7 at 1 and 5 minutes	during the intervention
Secondary	newborn admission in the neonatal intensive care unit	newborn admission in the neonatal intensive care unit (NICU).	immediately after intervention