Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)

NCT03751553 | Completed Phase 4

• 1 other identifier: obstetrical gel
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract in women undergoing a Vaginal Birth After Cesarean (VBAC).

Conditions

Duration of Labor

Outcome Measures

Primary Outcomes (1)

• length of the second stage of labor

  the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.

  1 hour

Study Arms (2)

obstetric gel group

EXPERIMENTAL

they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.

Drug: obsteric gel(k-Y jelly)

no intervention group

NO INTERVENTION

they will receive the standard care during labor and delivery without the use of the obstetrical gel

Interventions

obsteric gel(k-Y jelly) DRUG

A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson\& Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that have purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child manually or using the sterile obstetric gel applicator without any manipulation or massage.

obstetric gel group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40 years
• Women who have had only one prior cesarean birth with no previous vaginal delivery, are eligible for VBAC and plan to attempt a VBAC after counseling.
• Singleton baby in vertex presentation
• Low-risk pregnancy at term (37-41 weeks of gestation)
• Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
• Signed written informed consent

You may not qualify if:

• Contraindications for vaginal delivery (placenta previa, active herpes infection, etc…)
• Suspected amniotic infection (fever, foul-smelling discharge, fetal tachycardia, abdominal pain)
• A non-reassuring fetal heart tracing
• Prolonged rupture of the membranes (24 hours)
• Suspected major fetal malformations
• Suspected cephalopelvic disproportion

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Ashour

Giza, 12944, Egypt

Location

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: December 30, 2018
• Primary Completion: September 15, 2021
• Study Completion: October 15, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

EG (1)