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

NCT06069596 | Completed Phase 4 DMC

• 1 other identifier: 290819912
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parturition; Obstetric; Injury Pelvic Floor

Keywords

birth; parturition; obstetric lubricant gel; duration of second stage of labor; labor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Episiotomy rates

  Episiotomy is a technique performed during the second stage of labor.

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Natalis Obstetric Lubrican Gel 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.

Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Multiparous pregnancies and women who had ceserean section before and/or contraindication for vaginal delivery were excluded from the study.

Sponsors & Collaborators

• Ankara University: lead

Related Publications (2)

• 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.

  PMID: 28325124 BACKGROUND

• 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.

  PMID: 34569413 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 6, 2023
• Study Start: January 1, 2017
• Primary Completion: April 30, 2017
• Study Completion: July 15, 2018
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share