Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Duration of the Second Stage of Labor
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In this single-blind trial, the outcomes assessor is masked to group allocation. The outcomes assessor (the individual responsible for measuring and recording the primary and secondary outcomes, including duration of the second stage of labor, perineal integrity assessment, and Apgar scores) will not have access to the randomization list and will be unaware of whether the participant received the lubricant gel or standard care. This masking is maintained to minimize measurement and ascertainment bias in evaluating study endpoints. The statistician performing the final data analysis will also be blinded to group allocation. Participants and clinical care providers are not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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), application will be discontinued and appropriate clinical management provided.
干预措施: Obstetric Lubricant Gel (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 compared.
干预措施: Standard Active Management of Second Stage (Other)
结局指标
主要结局
Duration of the Second Stage of Labor
时间窗: 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.
次要结局
- Perineal Integrity(Immediately after delivery)
- Maternal Complications(From intervention until 7 days postpartum)
- Neonatal Apgar Score(1 minute and 5 minutes after birth)
- Need for Instrumental Delivery(30 minutes from intervention During delivery)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Research Coordinator
Universidad Nacional Autonoma de Honduras