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

Parturition Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06069596
Study type Interventional
Source Ankara University
Contact
Status Completed
Phase Phase 4
Start date January 1, 2017
Completion date July 15, 2018
View Details
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