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Completed

NCT Number: NCT03751553

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

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).

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Ashour

Giza, 12944, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. length of the second stage of labor

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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