NCT Number: NCT07428317
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.
Interested in participating?
Request Info18 year–49 year
Female
Interventional
Not applicable
Tegucigalpa, Francisco Morazán Department, 11101, Honduras
Location status: Recruiting
Elena A Castellanos Rivera, MD, MSc.
SUB_INVESTIGATOR
Gisselle A Fiallos Sierra, MD
PRINCIPAL_INVESTIGATOR
María A Delattibodier Perdomo, MD
PRINCIPAL_INVESTIGATOR
Ricardo A Gutierrez-Ramirez, MD, MSc.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Universidad Nacional Autonoma de Honduras
Other
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial
Acronym: OBY-GEL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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