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

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

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).

Study Overview

• Status: Completed
• Conditions: Duration of Labor
• Intervention / Treatment: Drug: obsteric gel(k-Y jelly)

Detailed Description

Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12944
    • Ahmed Ashour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• • 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: obstetric gel group; they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.	Drug: obsteric gel(k-Y jelly); 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.
No Intervention: no intervention group; they will receive the standard care during labor and delivery without the use of the obstetrical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2018
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: obstetrical gel

Drug and device information, study documents

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