Obstetrical Outcomes for Planned Deliveries in a French Birth Center (NidaModa)

May 20, 2023 updated by: Matthieu DAP, Central Hospital, Nancy, France

The main objective of this work is to study the obstetrical and neonatal outcomes of women who planned to deliver in the birth centre of Nancy.

The birth centre of Nancy is one of the nine french birth centres opened since 2015 on an experimental basis.

The women who plan to deliver at the birth centre must meet several conditions according to their medical history, pregnancy follow-up, and delivery progress.

The women can be transferred before, during or after (pre-, per- or post-) delivery to the hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

Yes

Sampling Method

Non-Probability Sample

Study Population

All women who want to deliver at the birth center "Un nid pour naître" since 01/01/2020 to 31/12/2022

Description

Inclusion Criteria:

  • women who want to deliver at the birth center "Un nid pour naître"

Exclusion Criteria:

  • Refusal to participate in the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women who planned to deliver at the brith center "un nid pour naître"
Other: delivery
delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the cesarean birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
rate of cesarean section
4 years
Comparison of the instrumental birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
rate of instrumental birth (vacuum or forceps delivery)
4 years
Comparison of the post-partum haemorrhage rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
rate of post-partum haemorrhage define by blood loss >= 500 cc
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the antepartum or peripartum stillbirth rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
4 years
Comparison of the hypoxemic encephalopathy rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
4 years
Comparison of the umbilical artery blood pH score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
4 years
Comparison of the five-minute Apgar score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time Frame: 4 years
Apgar score is a score that records the physical condition of a baby just after it is born, with ten points being the highest possible score and zero point the lowest.
4 years

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 9, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022PI173

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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