Lubricant gel to shorten the pushing phase of vaginal birth
Official title: Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial
Run by Universidad Nacional Autonoma de Honduras · NCT07428317 · Data updated 2026-11-12
This trial will try a single application of water-based obstetric lubricant during the second stage of labor to see if it shortens the pushing phase for term pregnant people planning a vaginal delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 49 Years |
| Sex | Women only |
| Enrollment | 160 (estimated) |
| Sponsor | Universidad Nacional Autonoma de Honduras Academic / other |
| Locations | 1 site (Tegucigalpa, Francisco Morazán Department) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | August 31, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT07428317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–40 with term (37–41.6 weeks) singleton pregnancies in spontaneous labor with cephalic presentation who plan a vaginal delivery and provide informed consent.
✕Probably not a fit
People with multiple pregnancy, prior cesarean, high-risk obstetric conditions, active infection, prolonged rupture of membranes, or known allergy to lubricant components are excluded and unlikely to receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-blind, randomized, parallel-group trial will compare one 50 mL application of sterile water-based lubricant into the vaginal canal at the onset of the second stage of labor versus standard care without lubrication. A total of 160 participants at Hospital Escuela in Tegucigalpa will be randomized 1:1 and followed from admission through immediate postpartum discharge. The primary outcome is duration of the second stage of labor in minutes; secondary outcomes include perineal tears, episiotomy rates, need for instrumental delivery, maternal infections, and neonatal Apgar scores. Safety will be overseen by a DSMB and statistical analyses will use ANCOVA for the primary outcome with logistic regression or nonparametric tests for secondary outcomes as appropriate.
Why it matters
Potential benefit: If effective, using lubricant during the second stage could shorten the pushing phase and reduce rates of perineal tears, episiotomy, or instrumental delivery.
How similar studies have gone: Routine clinical use and small prior trials have suggested lubrication may ease fetal passage, but high-quality randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Escuela
Tegucigalpa, Francisco Morazán Department, Honduras Recruiting
Study contacts
- Study coordinator: Ricardo A Gutierrez-Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: +50497546940
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.