NCT05080309 Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
| NCT ID | NCT05080309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Delivery Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-02-11 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2022-02-11 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
jean-luc hanouz, M.D., Ph.D.
STUDY CHAIR
University Hospital of Caen
Frequently Asked Questions
Who can join the NCT05080309 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Delivery Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05080309 currently recruiting?
Yes, NCT05080309 is actively recruiting participants. Contact the research team at hanouz-jl@chu-caen.fr for enrollment information.
Where is the NCT05080309 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05080309 clinical trial?
NCT05080309 is sponsored by University Hospital, Caen. The principal investigator is jean-luc hanouz, M.D., Ph.D. at University Hospital of Caen. The trial plans to enroll 600 participants.