An interventional study of Obstetric Lubricant Gel and Standard Active Management of Second Stage in Prolonged Second Stage of Labor, sponsored by Universidad Nacional Autonoma de Honduras. Recruiting at 1 site in Honduras. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Universidad Nacional Autonoma de Honduras · Not applicable, Interventional, and Treatment
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.
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.
Universidad Nacional Autonoma de Honduras is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 minutes from intervention During delivery
Maternal Satisfaction with Birth Experience
Participant-reported satisfaction with the birth experience, assessed using a Likert-scale questionnaire administered postpartum.
Time frame: Within 24-48 hours postpartum, prior to hospital discharge
Plan to share: Undecided — 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.
Started Feb 2026 (actual). Primary completion is estimated for Aug 2026, 6 months after the start.
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Universidad Nacional Autonoma de Honduras