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.
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
Multiple pregnancy
Previous cesarean section
High-risk pregnancy (preeclampsia, uncontrolled gestational diabetes, etc.)
Presence of fever or active infection
Parallel
Obstetric Lubricant Gel
Other interventionA 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.
Standard Active Management of Second Stage
Other interventionStandard, 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.
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.
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.
Maternal Complications
Occurrence of adverse events including local irritation, allergic reactions, postpartum hemorrhage, puerperal infection, or any other complication potentially associated with the intervention.
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.
Need for Instrumental Delivery
Requirement for operative vaginal delivery (forceps, vacuum) or emergency cesarean section during the second stage of labor.
Maternal Satisfaction with Birth Experience
Participant-reported satisfaction with the birth experience, assessed using a Likert-scale questionnaire administered postpartum.
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