Overview
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.
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.
Eligibility
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
