Oral carbohydrates (>44 kcal/hour) during labor to lower instrumental vaginal delivery in first-time mothers
Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
This project will test whether eating more than 44 kcal per hour during labor lowers the chance that first-time mothers need an instrumental vaginal delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT05080309 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares high-calorie oral carbohydrate intake (>44 kcal/hour) during labor with a control of free water only in nulliparous women with uncomplicated, term singleton pregnancies. Participants are enrolled at Caen University Hospital and receive either carbohydrate drinks during labor or only free water, with labor outcomes recorded. The main outcome is the rate of instrumental vaginal delivery (forceps or vacuum); common exclusions include scheduled cesarean or induction, diabetes, BMI >40, and cervical dilation >8 cm at enrollment. Previous small studies suggested a trend toward fewer instrumental deliveries with increased carbohydrate intake, but this trial aims to provide clearer evidence.
Who should consider this trial
Good fit: Ideal candidates are first-time (nulliparous) women at or beyond 37 weeks with a singleton, uncomplicated pregnancy who plan a vaginal birth and have no medical contraindications to oral intake.
Not a fit: Women with scheduled cesarean or induction, preterm labor, BMI over 40, diabetes, heart disease, hypertension, or contraindications to pushing or oral intake are unlikely to be eligible or receive benefit.
Why it matters
Potential benefit: If successful, this could reduce the need for forceps or vacuum deliveries and lower associated maternal and newborn complications.
How similar studies have performed: Small prior studies, including one by the same group, showed a non-significant trend toward fewer instrumental deliveries with higher carbohydrate intake, so the approach is plausible but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caen
- Caen University Hospital — Caen, France (Recruiting)
Study contacts
- Study coordinator: jean-luc hanouz
- Email: hanouz-jl@chu-caen.fr
- Phone: 33 2 31 06 47 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.