Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study

Phase 4

Completed

• Conditions: Parturition; Obstetric; Injury Pelvic Floor
• Interventions: Combination Product: Natalis Obstetric Lubrican Gel

• Registration Number: NCT06069596
• Lead Sponsor: Ankara University

Brief Summary

The investigators hypothesized that the application of lubricant gels at the beginning of the active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim of this study is to investigate and confirm this hypothesis through a randomised controlled trial.

All participants in the study received standard routine antepartum care in the delivery room. Obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups.

Detailed Description

The participants were divided into two groups based on their parity: nulliparous and primiparous. Initially, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups using a computer-generated random number table. In this randomized controlled trial, participant allocation was carried out using a computer program to ensure a randomized and unbiased selection process. The randomization procedure was conducted in a double-blind manner, with the study investigators remaining unaware of the allocation until the conclusion of the study. All participants in the study received standard routine antepartum care in the delivery room. Among all patients, 25 participants were lost to follow-up during the study. Consequently, obstetric lubricant gel was applied to patients in the study groups, which included 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-04-30
• Study Completion: 2018-07-15
• Study First Submitted: 2023-09-28
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-06
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• Nulliparous and primiparous singleton pregnancies between 37 and 41 weeks + six days of gestation and vertex presentation of fetus with an estimated birth weight of 2000 - 4500g were included in the study

Exclusion Criteria

• Multiparous pregnancies and women who had ceserean section before and/or contraindication for vaginal delivery were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Natalis Obstetric Lubrican Gel	obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients.

Primary Outcome Measures

Name	Time	Method
The duration of the second stage of labor was compared between the study and control groups	0 to 240 minutes	The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn.
The duration of the active phase of the first stage of labor was compared between the study and control groups	0 to 600 minutes	The active phase of labor begins when the cervical dilation is between 4-6 cm and refers to the time elapsed until full cervical dilation.

Secondary Outcome Measures

Name	Time	Method
Episiotomy rates	Episiotomy is a technique performed during the second stage of labor.	differences between study and control groups