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

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.

Study Overview

• Status: Completed
• Conditions: Parturition; Obstetric; Injury Pelvic Floor
• Intervention / Treatment: Combination product: Natalis Obstetric Lubrican Gel

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group; obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients.	Combination product: Natalis Obstetric Lubrican Gel; The obstetric lubricant gel was applied to the vaginal canal with a special applicator at the beginning of the active phase of the labor. The gel used in the study was highly viscose and isotonic with a slight acid pH of 6.0 - 6.7 and contained hydroxyethylcellulose, propylene glycol, glycerin. The gel box contained a sterile syringe (15 ml) and a flexible applicator.
No Intervention: Control group; obstetric lubricant gel was not applied to patients in the control groups, which had 55 nulliparous and 43 primiparous patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of the active phase of the first stage of labor was compared between the study and control groups	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.	0 to 600 minutes
The duration of the second stage of labor was compared between the study and control groups	The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn.	0 to 240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episiotomy rates	differences between study and control groups	Episiotomy is a technique performed during the second stage of labor.

Collaborators and Investigators

• Sponsor: Ankara University

Publications and helpful links

General Publications

• Seval MM, Yuce T, Yakistiran B, Sukur YE, Ozmen B, Atabekoglu C, Koc A, Soylemez F. Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial. J Obstet Gynaecol. 2017 Aug;37(6):714-718. doi: 10.1080/01443615.2017.1288711. Epub 2017 Mar 21.
• Azarkish F, Janghorban R, Bozorgzadeh S, Merbalouchzai F, Razavi M, Badiee M. Effect of lubricant gel on the length of the first stage of labour and perineal trauma in primiparous women. J Obstet Gynaecol. 2022 Jul;42(5):867-871. doi: 10.1080/01443615.2021.1946021. Epub 2021 Sep 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): July 15, 2018

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: birth; labor; parturition; obstetric lubricant gel; duration of second stage of labor
• Other Study ID Numbers: 290819912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No