The Effect of Chocolate Consumption During Labor on Second Stage Duration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Duration of second stage of labor
研究概览
简要总结
Childbirth is an energy-intensive physiological process, requiring sustained effort comparable in intensity to moderate physical activity. Studies suggest that providing an available energy source during labor, such as dextrose infusion or natural carbohydrate-rich foods such as dates, may shorten the duration of labor and improve cervical dilation without adversely affecting obstetric outcomes. The primary objective of the study is to examine whether giving chocolate during labor affects the duration of the second stage of labor, compared to a control group that will not receive a nutritional intervention. The study is a prospective, randomized, controlled trial that will be conducted in the delivery room of Hillel Yaffe Medical Center. Healthy pregnant women with a singleton pregnancy at ≥37 weeks gestational age, in spontaneous or induced labor, without diabetes (pre/gestational), will be recruited to participate. Participants in the intervention group will receive one serving of 50 grams of milk chocolate (cocoa content 25-30%, without filling or additives) at a cervical dilation of 6 cm or more (and not yet fully dilated). The mother will be asked to consume the serving gradually over 30 minutes. Milk chocolate was chosen because it is better tolerated compared to dark chocolate, has a more gentle profile of active ingredients (which can increase nausea and heartburn) and provides a source of available carbohydrates. The study will be conducted in accordance with the guidelines of the Ministry of Health's procedure for medical experiments on humans, and will be conducted after approval by the Institutional Helsinki Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. Masking is not feasible due to the nature of the intervention. However, the primary outcome is an objective measure, minimizing the risk of assessment bias.
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥37 weeks
- •Single fetus in cephalic presentation
- •Spontaneous or induced labor in the active phase (dilation ≥ 5 cm).
- •Normal assessment of the mother and fetus upon admission to the delivery room (normal indices, normal monitoring and biophysical profile)
- •BMI 18-35 -
排除标准
- •Multiple pregnancies
- •Gestational age <37 weeks
- •Gestational or pre-gestational diabetes
- •Significant underlying diseases
- •Previous cesarean section/myomectomy
- •Known significant fetal malformation
- •Sensitivity to chocolate ingredients
- •Lack of documentation of necessary information -
研究组 & 干预措施
50 g of milk chocolate cocoa content 25-30%
. Participants in the intervention group will receive one serving of 50 grams of milk chocolate (cocoa content 25-30%, without filling or additives) at a cervical dilation of 6 cm or more. The mother will be asked to consume the serving gradually over 30 minutes.
干预措施: 50 g of milk chocolate cocoa content 25-30% (Other)
control group - no intervention
Participants in the control group will receive routine care as is customary in the delivery room, without any proactive nutritional supplementation.
结局指标
主要结局
Duration of second stage of labor
时间窗: From full cervical dilation to delivery
The duration of the second stage of labor, defined as the time in minutes from full cervical dulation (10cm) to delivery of the neonate.
次要结局
- Mode of delivery(At delivery)
- Maternal nausea or vomiting during labor(From intervention administration untill discharge from labor room)
- Neonatal Apgar score at 1 and 5 minutes(1 and 5 minutes after delivery)
- Umbilical cord blood glucose level(at delivery)
- Maternal heart rate(During the second stage of labor)
- Umbelical cord blood PH(At delivery)
