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

• Sponsor: Ankara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06069596
• Collaborator: (none)
• Enrollment: 220
• Arms: 2
• Actual Duration (Months): 18.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parturition; Obstetric; Injury Pelvic Floor	Combination Product: Natalis Obstetric Lubrican Gel	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The participants were divided into two groups based on their parity; nulliparous and primiparous. At the outset, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups by using a computer generating random number table. Obstetric lubricant gel was applied to patients in the study groups. Perinatal outcomes and durations of the labor were compared between study and control groups.The participants were divided into two groups based on their parity; nulliparous and primiparous. At the outset, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups by using a computer generating random number table. Obstetric lubricant gel was applied to patients in the study groups. Perinatal outcomes and durations of the labor were compared between study and control groups.
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Randomization was performed using a computer program. Accordingly, the study group patients were administered Obstetric gel. The researcher administering Obstetric gel ensured the blinding of healthcare providers and other researchers.
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Apr 30, 2017
• Actual Study Completion Date: Jul 15, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. Episiotomy rates [Episiotomy is a technique performed during the second stage of labor.]

   differences between study and control groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ankara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: kaan baydemir, Investigator, Ankara University
• ClinicalTrials.gov Identifier: NCT06069596
• Other Study ID Numbers: 290819912
• First Posted: Oct 6, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by kaan baydemir, Investigator, Ankara University: birth; parturition; obstetric lubricant gel; duration of second stage of labor; labor

Study Results

No Results Posted as of Oct 12, 2023