Modifying Nutrition to Modify Delivery in Nulliparous Women (MAMAN)

May 16, 2024 updated by: University Hospital, Tours

Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Tours, France, 37044
        • Gynaecology-obstetrics, University Hospital, Tours
        • Contact:
        • Principal Investigator:
          • Caroline DIGUISTO, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women
  • Age ≥ 18 years
  • Nulliparous
  • Single pregnancy with fetus in cephalic presentation
  • Pregnancy with physiological course
  • Gestational age ≥ 34 and ⩽ 37 SA
  • Membership of a social security scheme (CMU accepted)
  • Signed informed consent

Exclusion Criteria:

  • Any contraindication to vaginal delivery
  • Presence of a foetal malformation
  • Diabetes of any type (1, 2 or gestational)
  • Food allergy contraindicating participation in the study
  • Illiterate or non-French-speaking women
  • Women under guardianship or trusteeship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dietary advice + food supplied
Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need.
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: food supplied
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
Experimental: dietary advice alone
Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided.
Other: dietary advice alone
Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.
No Intervention: usual care
No specific dietary advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.
Time Frame: From 37 weeks'amenorrhoea to delivery (up to 41 weeks)
From 37 weeks'amenorrhoea to delivery (up to 41 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of women's experience of the intervention using a post-partum questionnaire
Time Frame: Following childbirth, during the stay in the maternity ward ; assessed up to 5 days
Following childbirth, during the stay in the maternity ward ; assessed up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Adeline DE WITT, MD, University Hospital, Orléans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DR230083

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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