Left Lateral Position Versus Supine Position in Reducing the Duration of the Active Phase of Labor: A Randomized, Single-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Duration of the active phase of labor.
研究概览
简要总结
This randomized clinical trial aims to compare the effect of the left lateral decubitus position versus the supine position on the duration of the active phase of labor in nulliparous women. A total of 188 participants will be randomly assigned to one of two groups. The intervention group will be placed in the left lateral decubitus position, while the control group will remain in the supine position. Both positions will be maintained for 30-minute intervals with 5-minute rest periods, continuing until delivery. The primary outcome is the duration of the active phase of labor. Secondary outcomes include rates of cesarean section, use of oxytocin and analgesics, and maternal and neonatal complications.
详细描述
Globally, maternal positioning during labor is a key component of humanized childbirth. While the World Health Organization recommends allowing women to adopt comfortable positions, the supine position remains prevalent in many clinical settings for practitioner convenience. This study in Honduras seeks to generate local evidence on the impact of maternal position on labor progression. Nulliparous women at term (≥37 weeks) with a singleton pregnancy in cephalic presentation and in the active phase of labor (≥6 cm dilation) will be recruited from the labor and delivery unit of the Hospital Materno Infantil. After providing informed consent, participants will be randomized. The primary efficacy endpoint is the time from the onset of the active phase (or intervention start, if later) until delivery. The study hypothesizes that the left lateral position will significantly reduce active labor duration compared to the supine position, potentially reducing unnecessary surgical interventions and improving the childbirth experience.
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
The groups will be labeled "AGroup" and "B Group" during data collection and tabulation. The statistician performing the analysis will be blinded to which group corresponds to which intervention until the analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent form.
- •Nulliparous woman.
- •Singleton pregnancy at ≥37 weeks of gestation.
- •Intact amniotic membranes.
- •Cephalic presentation.
- •In the active phase of labor (cervical dilation ≥6 cm).
- •Age ≥18 years.
- •No contraindication for vaginal delivery.
- •Possession of a mobile phone (for potential follow-up contact).
排除标准
- •Previous uterine surgery.
- •Maternal condition preventing vaginal delivery.
- •Fetal anomaly.
- •Premature rupture of membranes.
- •Multiple pregnancy.
- •Fetal demise.
- •Uterine myomas.
- •Maternal comorbidities (e.g., chronic hypertension, diabetes mellitus type -1/2/gestational, hypothyroidism).
- •Age <18 years.
- •Preterm gestation (<37 weeks).
研究组 & 干预措施
Left Lateral Decubitus Position
Participants will be placed in the left lateral decubitus position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.
干预措施: Left Lateral Decubitus Group (Other)
Supine Position Group
Participants will remain in the supine position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.
干预措施: Supine Position Group (Other)
结局指标
主要结局
Duration of the active phase of labor.
时间窗: Time (in minutes) from the diagnosis of the active phase of labor (cervical dilation ≥6 cm) to delivery of the newborn. Within the first 24 hours after diagnosis of active phase.
The primary objective is to measure and compare the time taken to progress from the active phase to delivery between the two positioning groups.
次要结局
- Incidence of Cesarean Delivery(From randomization until delivery (anticipated within 48 hours per participant).)
- Use of Oxytocin for labor augmentation/conduction.(From randomization until delivery.)
- Incidence of maternal complications (e.g., perineal tears, hemorrhage, hypotension).(From randomization until hospital discharge (approximately 24-48 hours postpartum).)
- Neonatal status as measured by Apgar score.(At 1 minute and 5 minutes after birth.)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Research Coordinator
Universidad Nacional Autonoma de Honduras