The Effect of Chocolate Consumption During Labor on Second Stage Duration

Обзор

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.

Вмешательства

• Другое 50 g of milk chocolate cocoa content 25-30%
  Milk chocolate was chosen as it is better tolerated compared to dark chocolate, has a milder profile of active ingredients (which can increase nausea and heartburn) and provides a source of available carbohydrates. A dose of 50 grams was chosen that provides 25-30 grams of simple carbohydrates - sufficient for a significant increase in blood glucose but low enough to prevent a sudden sugar load or nausea. The intervention will be given at 6-9 cm dilation, towards the transition to the second p

Первичные конечные точки

• Duration of second stage of labor [Срок оценки: From full cervical dilation to delivery]

Вторичные конечные точки (6)

• Mode of delivery [Срок оценки: At delivery]
• Maternal nausea or vomiting during labor [Срок оценки: From intervention administration untill discharge from labor room]
• Neonatal Apgar score at 1 and 5 minutes [Срок оценки: 1 and 5 minutes after delivery]
• Umbilical cord blood glucose level [Срок оценки: at delivery]
• Maternal heart rate [Срок оценки: During the second stage of labor]
• Umbelical cord blood PH [Срок оценки: At delivery]

Критерии участия

Критерии включения

• 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 -

Критерии исключения

• 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 -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07375836 · 0200-25-HYMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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