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

Phase 4

Completed

• Conditions: Duration of Labor
• Interventions: Drug: obsteric gel(k-Y jelly)

• Registration Number: NCT03751553
• Lead Sponsor: Cairo University

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).

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 Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2018-12-30
• Primary Completion: 2021-09-15
• Study Completion: 2021-10-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
obstetric gel group	obsteric gel(k-Y jelly)	they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.

Primary Outcome Measures

Name	Time	Method
length of the second stage of labor	1 hour	the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.

Trial Locations

Locations (1)

Ahmed Ashour; 🇪🇬 Giza, Egypt