Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma

Labor Stage, Second Clinical Trial

Official title: Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial

Status Completed

Clinical Trial Summary

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.

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. Neonatal and maternal morbidities will be also assessed.

The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either:

• Group 1 who will receive the standard care during labor and delivery

• Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel The goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Labor Stage, Second

• NCT number: NCT03518684
• Study type: Interventional
• Source: American University of Beirut Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2018
• Completion date: June 30, 2019