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

February 16, 2026 updated by: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Honduras
    • Francisco Morazán Department
      • Tegucigalpa, Francisco Morazán Department, Honduras, 11101
        • Recruiting
        • Hospital Escuela
        • Contact:
        • Principal Investigator:
          • María A Delattibodier Perdomo, MD
        • Principal Investigator:
          • Gisselle A Fiallos Sierra, MD
        • Sub-Investigator:
          • Elena A Castellanos Rivera, MD, MSc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of the Second Stage of Labor
Time Frame: During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perineal Integrity
Time Frame: Immediately after delivery
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
Time Frame: From intervention until 7 days postpartum
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
Time Frame: 1 minute and 5 minutes after birth
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
Time Frame: 30 minutes from intervention During 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Satisfaction with Birth Experience
Time Frame: Within 24-48 hours postpartum, prior to hospital discharge
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Nacional Autonoma de Honduras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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