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The Effect of Chocolate Consumption During Labor on Second Stage Duration

H

Hillel Yaffe Medical Center

Status

Not yet enrolling

Conditions

Labor
Second Stage of Labor
Pregnancy

Treatments

Other: 50 g of milk chocolate cocoa content 25-30%

Study type

Interventional

Funder types

Other

Identifiers

NCT07375836
0200-25-HYMC

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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 -

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

50 g of milk chocolate cocoa content 25-30%
Experimental group
Description:
. 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.
Treatment:
Other: 50 g of milk chocolate cocoa content 25-30%
control group - no intervention
No Intervention group
Description:
Participants in the control group will receive routine care as is customary in the delivery room, without any proactive nutritional supplementation.

Trial contacts and locations

0

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Central trial contact

Rinat Gabbay-Benziv, M.D; Libby O Madar, M.D

Data sourced from clinicaltrials.gov

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