MedTrace Logo

Modifying Nutrition to Modify Delivery in Nulliparous Women

NCT06419192 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-05-17

No results posted yet for this study

Summary

In France, around 20% of women exceed the term of 41 weeks' amenorrhoea (SA). Maternal and foetal morbidity and mortality are increased when the term is exceeded, which justifies inducing labour. However, induction also increases maternal and foetal morbidity.

According to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth.

Single-centre, randomised, open-label, 3-arm study :

Experimental group n°1: 'dietary advice + food provided'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The quantity of dates required will be provided to the women.

Experimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided.

Control group: no specific dietary advice. Routine care group.

Conditions

  • Pregnant Woman

Interventions

OTHER

dietary advice

Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.

OTHER

dietary advice alone

Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.

OTHER

food supplied

Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Adeline DE WITT, MD · University Hospital, Orléans

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-07-31
Completion
2025-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419192 on ClinicalTrials.gov