Clinical trial NCT06069596: Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
Official title: Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parturition
Obstetric; Injury Pelvic Floor
Keywords: birth
parturition
obstetric lubricant gel
duration of second stage of labor
labor
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: The duration of the active phase of the first stage of labor was compared between the study and control groups
timeFrame: 0 to 600 minutes
measure: The duration of the second stage of labor was compared between the study and control groups
timeFrame: 0 to 240 minutes
Secondary outcomes:
measure: Episiotomy rates
timeFrame: Episiotomy is a technique performed during the second stage of labor.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.