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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-07-15

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Parturition Obstetric; Injury Pelvic Floor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Study Groups

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Study group

obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients.

Group Type ACTIVE_COMPARATOR

Natalis Obstetric Lubrican Gel

Intervention Type COMBINATION_PRODUCT

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.

Control group

obstetric lubricant gel was not applied to patients in the control groups, which had 55 nulliparous and 43 primiparous patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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