Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery

NCT07428317 | Recruiting DMC

• 1 other identifier: PGO-UNAH-49-2-2026
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental study aims to evaluate whether the application of obstetric lubricant gel during vaginal delivery can significantly reduce the duration of the second stage of labor, preserve perineal integrity, and decrease the need for episiotomies. The study hypothesis is that lubricant gel facilitates fetal passage through the birth canal by reducing friction, shortening the expulsion phase and reducing maternal-neonatal complications. Two groups will be included: with and without gel application. Follow-up will span from admission of the pregnant woman until immediate postpartum discharge.

Conditions

Prolonged Second Stage of Labor

Keywords

Lubricant Gel; Second Stage of Labor; Perineal Integrity; Episiotomy; Vaginal Delivery; Obstetric Gel; Labor Duration; Birth Canal Lubrication

Outcome Measures

Primary Outcomes (1)

• Duration of the Second Stage of Labor

  Time in minutes from complete cervical dilation (10 cm) to expulsion of the fetus. Measured and recorded by attending obstetric staff using a standardized timer or clock.

  During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)

Secondary Outcomes (4)

• Perineal Integrity

  Immediately after delivery

• Maternal Complications

  From intervention until 7 days postpartum

• Neonatal Apgar Score

  1 minute and 5 minutes after birth

• Need for Instrumental Delivery

  30 minutes from intervention During delivery

Other Outcomes (1)

• Maternal Satisfaction with Birth Experience

  Within 24-48 hours postpartum, prior to hospital discharge

Study Arms (2)

Obstetric Lubricant Gel

EXPERIMENTAL

A single 50 mL dose of sterile, water-soluble, biocompatible lubricant gel applied intravaginally at the onset of the second stage of labor. The gel is applied to the anterior and posterior vaginal walls using sterile technique to reduce friction during fetal descent and expulsion. The product is used according to its approved indications; no modification has been made for this study. Application is performed by trained medical personnel. In case of local adverse reaction (burning, irritation), application will be discontinued and appropriate clinical management provided.

Other: Obstetric Lubricant Gel

Standard Active Management of Second Stage

SHAM COMPARATOR

Standard, evidence-based active management of the second stage of labor according to institutional protocol, without the addition of lubricant gel. This includes continuous maternal-fetal monitoring, supportive care, encouragement of spontaneous pushing, and delivery assistance as per routine practice. All aspects of care are identical to the intervention group except for the application of lubricant gel. This represents the current standard of care against which the experimental intervention is compared.

Other: Standard Active Management of Second Stage

Interventions

Standard Active Management of Second Stage OTHER

Standard, evidence-based active management of the second stage of labor according to institutional protocol, without the addition of lubricant gel. This includes continuous maternal-fetal monitoring, supportive care, encouragement of spontaneous pushing, and delivery assistance as per routine practice. All aspects of care are identical to the intervention group except for the application of lubricant gel. This represents the current standard of care against which the experimental intervention is compared.

Standard Active Management of Second Stage

Obstetric Lubricant Gel OTHER

A single 50 mL dose of sterile, water-soluble, biocompatible lubricant gel applied intravaginally at the onset of the second stage of labor. The gel is applied to the anterior and posterior vaginal walls using sterile technique to reduce friction during fetal descent and expulsion. The product is used according to its approved indications; no modification has been made for this study. Application is performed by trained medical personnel. In case of local adverse reaction (burning, irritation), application will be discontinued and appropriate clinical management provided.

Obstetric Lubricant Gel

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form
• Willingness to comply with study procedures
• Age between 18 and 40 years
• Term pregnancy (37-41.6 weeks) with active labor
• Diagnosis of spontaneous labor and planned vaginal delivery
• Fetus in cephalic presentation
• Agreement to comply with lifestyle restrictions during the study

You may not qualify if:

• Multiple pregnancy
• Previous cesarean section
• High-risk pregnancy (preeclampsia, uncontrolled gestational diabetes, etc.)
• Presence of fever or active infection
• Contraindication for vaginal delivery
• Refusal to sign informed consent
• Premature rupture of membranes \>18 hours without labor
• Known allergy to lubricant gel components
• Participation in another clinical trial in the last 3 months

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Related Publications (1)

• De Ferrari L, Chiappori A, Bagnasco D, Riccio AM, Passalacqua G, Canonica GW. Molecular phenotyping and biomarker development: are we on our way towards targeted therapy for severe asthma? Expert Rev Respir Med. 2016;10(1):29-38. doi: 10.1586/17476348.2016.1111763. Epub 2015 Nov 13.

  PMID: 26566089 BACKGROUND

Central Study Contacts

Ricardo A Gutierrez-Ramirez, MD, MSc

CONTACT

+50497546940; ricardo.gutierrez@unah.edu.hn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this single-blind trial, the outcomes assessor is masked to group allocation. The outcomes assessor (the individual responsible for measuring and recording the primary and secondary outcomes, including duration of the second stage of labor, perineal integrity assessment, and Apgar scores) will not have access to the randomization list and will be unaware of whether the participant received the lubricant gel or standard care. This masking is maintained to minimize measurement and ascertainment bias in evaluating study endpoints. The statistician performing the final data analysis will also be blinded to group allocation. Participants and clinical care providers are not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

HO (1)