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

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.

Study Overview

• Status: Completed
• Conditions: Labor Stage, Second
• Intervention / Treatment: Drug: Natalis

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Amercian University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age between 18 and 40 years
• Intended vaginal delivery
• Singleton baby in vertex presentation
• Low risk pregnancy at term (37-42 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…)
• Advanced cervical dilation (≥ 5 cm)
• Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
• 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1; Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel
Experimental: Group 2; Group 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous [never delivered beyond 20 weeks of gestation in a previous pregnancy] or primiparous or more)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the length of the second stage of labor	40% reduction in the duration of the second stage of labor with a calculated average duration of 66.5 min. Thus a reduction to 39.9 minutes for every patient recruited	Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OGY.EH.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes