| Registry | NCT07375836 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 180 (Estimated) |
| Sponsor | Hillel Yaffe Medical Center (Other gov) |
| Conditions | Labor, Second Stage of Labor, Pregnancy |
| Interventions | 50 g of milk chocolate cocoa content 25-30% (Other) |
| Dates | start 2026-02-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-01-29, last updated 2026-02-04 |
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All trials for Labor All trials for Second Stage of Labor All trials of 50 g of milk chocolate cocoa content 25-30%
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 50 g of milk chocolate cocoa content 25-30% | Experimental | Other: 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. |
| control group - no intervention | No intervention | Participants in the control group will receive routine care as is customary in the delivery room, without any proactive nutritional supplementation. |
Sex: Female, ages: 18 Years to 50 Years
Inclusion Criteria: 1. Gestational age ≥37 weeks 2. Single fetus in cephalic presentation 3. Spontaneous or induced labor in the active phase (dilation ≥ 5 cm). 4. Normal assessment of the mother and fetus upon admission to the delivery room (normal indices, normal monitoring and biophysical profile) 5. BMI 18-35 - Exclusion Criteria: 1. Multiple pregnancies 2. Gestational age <37 weeks 3. Gestational or pre-gestational diabetes 4. Significant underlying diseases 5. Previous cesarean section/myomectomy 6. Known significant fetal malformation 7. Sensitivity to chocolate ingredients 8. Lack of documentation of necessary information -