Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Va… (NCT05080309) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
France600 participantsStarted 2022-02-11
Plain-language summary
Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.
In a previous study we reported a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake during labour. However due to some limitations no clear conclusion could be drawn.
The present study is designed to examine the relationship between a high calory oral intake (\>44 kCal/hour during labour) and the rate of instrumental delivery.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* nulliparous women
* singleton pregnancy
* social insurance
* uncomplicated pregnancy
* no contraindication to vaginal delivery
Exclusion Criteria:
* scheduled caesarean section
* labor \< 37 weeks of gestational age
* cervical dilation \> 8cm at inclusion
* scheduled induced delivery
* contraindication to pushing effort during labor and delivery
* BMI \> 40 kg/m2
* medical history of diabetes mellitus, hypertension, heart disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves eating carbohydrates during labor — is that something that would be safe for me given my specific pregnancy history and any risks I might have, like needing an emergency C-section?
2The trial is measuring whether eating more than 44 calories per hour of carbohydrates during labor reduces the need for assisted vaginal delivery using instruments like forceps or a vacuum — what does my doctor think is currently driving my risk for that kind of delivery?
3Since this trial doesn't have a specific phase listed and seems to be testing a dietary approach rather than a drug, what does my doctor know about the current evidence on eating during labor, and how does this study add to that?
4If I were to take part, would I have any control over what I eat, or would the amount and type of carbohydrates be strictly assigned to me, and how might that interact with conditions like gestational diabetes?
5Are there standard care options already available — like labor support strategies or positioning — that my doctor would recommend I consider before deciding whether joining a study like this makes sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.