Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery (OBY-GEL)

Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Prolonged Second Stage of Labor
• Intervention / Treatment: Other: Obstetric Lubricant Gel; Other: Standard Active Management of Second Stage

Detailed Description

This is a single-blind, randomized, parallel-group, controlled clinical trial comparing obstetric lubricant gel application versus standard care during the second stage of labor. The intervention consists of a single 50 mL application of water-based, sterile lubricant gel (e.g., Gynotal®, Dianatal®, or equivalent) into the vaginal canal (anterior and posterior walls) at the onset of the second stage of labor (complete cervical dilation with confirmed cephalic presentation). The control group receives standard obstetric care without lubrication. The primary outcome is duration of the second stage of labor in minutes. Secondary outcomes include perineal integrity (tears, episiotomy), maternal complications (infections, adverse reactions), neonatal Apgar scores at 1 and 5 minutes, and need for instrumental delivery. The study will be conducted at Hospital Materno Infantil, Tegucigalpa, Honduras, with a target enrollment of 160 participants (80 per group). Randomization will be performed using simple block allocation. Statistical analysis will include ANCOVA for the primary outcome, logistic regression for binary secondary outcomes, and appropriate non-parametric tests if assumptions are violated. A Data Safety Monitoring Board (DSMB) will oversee safety every 6 months or after every 20 inclusions.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo A Gutierrez-Ramirez, MD, MSc; Phone Number: +50497546940; Email: ricardo.gutierrez@unah.edu.hn

Study Locations

• Honduras
  • Francisco Morazán Department
    • Tegucigalpa, Francisco Morazán Department, Honduras, 11101
      • Recruiting
      • Hospital Escuela
      • Contact: Ricardo A Gutierrez-Ramirez, MD, MSc.; Phone Number: 97546940; Email: ricardo.gutierrez@unah.edu.hn
      • Principal Investigator: María A Delattibodier Perdomo, MD
      • Principal Investigator: Gisselle A Fiallos Sierra, MD
      • Sub-Investigator: Elena A Castellanos Rivera, MD, MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obstetric Lubricant Gel; 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; 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.
Sham Comparator: Standard Active Management of Second Stage; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineal Integrity	Incidence and severity of perineal tears (classified by degree: 1st, 2nd, 3rd, 4th degree) and performance of episiotomy. Assessed by attending obstetrician immediately after delivery.	Immediately after delivery
Maternal Complications	Occurrence of adverse events including local irritation, allergic reactions, postpartum hemorrhage, puerperal infection, or any other complication potentially associated with the intervention.	From intervention until 7 days postpartum
Neonatal Apgar Score	Apgar score assessed at 1 minute and 5 minutes after birth. Score ranges from 0-10, with higher scores indicating better neonatal condition.	1 minute and 5 minutes after birth
Need for Instrumental Delivery	Requirement for operative vaginal delivery (forceps, vacuum) or emergency cesarean section during the second stage of labor.	30 minutes from intervention During delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Satisfaction with Birth Experience	Participant-reported satisfaction with the birth experience, assessed using a Likert-scale questionnaire administered postpartum.	Within 24-48 hours postpartum, prior to hospital discharge

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Honduras

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Episiotomy; Vaginal Delivery; Second Stage of Labor; Perineal Integrity; Labor Duration; Lubricant Gel; Obstetric Gel; Birth Canal Lubrication
• Other Study ID Numbers: PGO-UNAH-49-2-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (anonymized) will be shared for scientific purposes related to maternal-perinatal health. The final dataset will be deposited in the Central American Clinical Data Repository (RCDC) under CC-BY-NC 4.0 license. Only de-identified datasets will be shared, with prior ethics committee approval. Participants may opt in/out during informed consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No