Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Obstetric Lubricant Gel, Standard Active Management of Second Stage.
- Who it may be relevant to
- Registry conditions: Prolonged Second Stage of Labor. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Honduras
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial
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.
Detailed 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.
Interventions
- Other Obstetric Lubricant Gel
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), - Other Standard Active Management of Second Stage
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
Primary outcome measures
- Duration of the Second Stage of Labor [Time frame: During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)]
Secondary outcome measures (4)
- Perineal Integrity [Time frame: Immediately after delivery]
- Maternal Complications [Time frame: From intervention until 7 days postpartum]
- Neonatal Apgar Score [Time frame: 1 minute and 5 minutes after birth]
- Need for Instrumental Delivery [Time frame: 30 minutes from intervention During delivery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Honduras · 1 center
- Hospital Escuela — Tegucigalpa
Publications
- De Ferrari L, Chiappori A, Bagnasco D, Riccio AM, Passalacqua G, Canonica GW. Molecular phenotyping and biomarker development: are we on our way towards targeted therapy for severe asthma? Expert Rev Respir Med. 2016;10(1):29-38. doi: 10.1586/17476348.2016.1111763. Epub 2015 Nov 13. PMID 26566089
Identifiers
NCT: NCT07428317 · PGO-UNAH-49-2-2026