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

NCT03518684 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: OGY.EH.03
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

NO INTERVENTION

Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel

Group 2

EXPERIMENTAL

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

Interventions

Natalis DRUG

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

Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

Amercian University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Obstetrics and Gynecology

Model Details: In this randomized controlled study, the patients will be randomly assigned to either Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel or 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). Based on our departmental statistics, \~90% of laboring patients receive epidural. Hence receiving an epidural will not have a major impact on the duration of the second stage of labor; yet, whether the patient received epidural or not will be adjusted for.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 8, 2018
• Study Start: April 3, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 30, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

LE (1)