NCT03518684

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Labor Stage, Second

Interventions

Type	Name	Description
DRUG	Natalis	A specially-designed sterile obstetric gel (Natalis) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that has a purely physical activity. It contains propylene glycol, glycerol, sodium chloride, xanthan gum, hydroxyethylcellulose and water. 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 using the sterile obstetric gel applicator without any manipulation or massaging. Additional obstetric gel will be added 15-30 minutes after rupture of the membranesOnce the head of the child is visible, the mouth and nose region will be wiped clean. A dry towel will be used to liberate the child in order to prevent the child from slipping

Timeline

• Start date: 2018-04-03
• Primary completion: 2019-06-28
• Completion: 2019-06-30
• First posted: 2018-05-08
• Last updated: 2020-09-03

Locations

1 site across 1 country: Lebanon

Regulatory

• FDA-regulated drug study