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

• ClinicalTrials.gov Identifier: NCT03518684
• Recruitment Status: Completed
• First Posted: May 8, 2018
• Last Update Posted: September 3, 2020
• Sponsor: American University of Beirut Medical Center
• Information provided by (Responsible Party): Elie Hobeika, American University of Beirut Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Labor Stage, Second	Drug: Natalis	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial
• Actual Study Start Date: April 3, 2018
• Actual Primary Completion Date: June 28, 2019
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Reduction in the length of the second stage of labor [ Time Frame: Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Lebanon

Amercian University of Beirut Medical Center

Beirut, Lebanon

Sponsors and Collaborators

American University of Beirut Medical Center

More Information

• Responsible Party: Elie Hobeika, Assistant Professor of Clinical Obstetrics and Gynecology, American University of Beirut Medical Center
• ClinicalTrials.gov Identifier: NCT03518684
• Other Study ID Numbers: OGY.EH.03
• First Posted: May 8, 2018
• Last Update Posted: September 3, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

• 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