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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518684
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Elie Hobeika, American University of Beirut Medical Center

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

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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

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





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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518684


Locations
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Lebanon
Amercian University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
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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    Key Record Dates
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)

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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