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

Early Versus Late Amniotomy on Labour Induction in Nulliparous Women

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

Study Overview

• Status: Completed
• Conditions: Labour Induction
• Intervention / Treatment: Drug: Misoprostol

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 11111
      • Menoufia university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: early amniotomy; Group A: Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached.; Early amniotomy was performed for the participant of the first group at 3 cementer cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix.	Drug: Misoprostol; rupture of membrane early and late; Other Names: Amniotomy
Active Comparator: Late amniotomy; Group B: Pregnant women had taken misoprostol (vagiprost vaginal tablet; Adwia Pharmaceutical Company) vaginally as 25 micro gram of misoprostol. It was repeated every 6 hours until three or more uterine contractions of 40 second duration occur over 10 minutes, or when reaching four doses maximum (i.e. 100 micro gram) is reached.; late amniotomy was performed for the participant of the second group at 7 cementer cervical dilatation.	Drug: Misoprostol; rupture of membrane early and late; Other Names: Amniotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful induction	definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction	immediately after intervention
induction-delivery interval	duration of labor and amniotomy delivery interval	immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
misoprostol doses administered	number of misoprostol doses administered	during the intervention
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
intrapartum meconium	intrapartum meconium passage	during the intervention
Apgar score	Apgar score less than 7 at 1 and 5 minutes	during the intervention
newborn admission in the neonatal intensive care unit	newborn admission in the neonatal intensive care unit (NICU).	immediately after intervention

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 11/2019 OBSGN 27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No