- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375836
The Effect of Chocolate Consumption During Labor on Second Stage Duration
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Libby O Madar, M.D
- Phone Number: +972-4-7744602
- Email: NoaAl@hymc.gov.il
Study Contact Backup
- Name: Rinat Gabbay-Benziv, M.D
- Phone Number: +972-4-7744514
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 -
Exclusion Criteria:
- 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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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. |
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of second stage of labor
Time Frame: 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.
|
From full cervical dilation to delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mode of delivery
Time Frame: At delivery
|
Mode of delivery categorized as spontanous vaginal delivery, operative vaginal delivery (vacuum), or cesarean delivery
|
At delivery
|
|
Maternal nausea or vomiting during labor
Time Frame: From intervention administration untill discharge from labor room
|
The occurrence of maternal nausea or vomiting during labor following the assigned intervention, as documented in the medical record
|
From intervention administration untill discharge from labor room
|
|
Umbilical cord blood glucose level
Time Frame: at delivery
|
Umbilical cord blood glucose concentration measured from umbelical blood collected immediately after delivery (when a cord blood sample is obtained per routine practice
|
at delivery
|
|
Maternal heart rate
Time Frame: During the second stage of labor
|
Maternal heart rate measured in beats per minute as recorded by continous intrapartum maternal monitorind
|
During the second stage of labor
|
|
Umbelical cord blood PH
Time Frame: At delivery
|
Umbelical cord blood PH measures immediatley after delivery
|
At delivery
|
|
Neonatal Apgar score at 1 and 5 minutes
Time Frame: 1 and 5 minutes after delivery
|
The Apgar score is assessed at 1 and 5 minutes after delivery.
The total score ranges from 0 to 10, with higher scores indicating better neonatal condition.
|
1 and 5 minutes after delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0200-25-HYMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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