NCT07375836

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 21, 2026

Last Update Submit

February 1, 2026

Conditions

Keywords

Second stage of laborOral carbohydrate intakeNon-pharmacologic interventionMaternal exhaustionPregnancyLaborRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Duration of second stage of labor

    The duration of the second stage of labor, defined as the time in minutes from full cervical dulation (10cm) to delivery of the neonate.

    From full cervical dilation to delivery

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

50 g of milk chocolate cocoa content 25-30%

EXPERIMENTAL

. 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.

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

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.

Interventions

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 phase - to allow the absorption of glucose and neurochemicals to be deafened at a time when the body needs increased energy and alertness. Giving it earlier may result in the effect of the chocolate wearing off before the second phase, and later - there will be no time for effective absorption.

50 g of milk chocolate cocoa content 25-30%

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt is limited due to the ability to give birth
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Libby O Madar, M.D

CONTACT

Rinat Gabbay-Benziv, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized, parallel-group interventional study. Eligible participants will be randomized in a 1:1 ratio to receive either oral carbohydrate supplementation (chocolate) prior to second stage of labor, or standard intrapartum care. Outcomes will be compared between groups. The primary outcome is the duration of second stage of labor, with secondary maternal and neonatal outcomes assessed.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share