NidaModa: Obstetrical Outcomes for Planned Deliveries in a French Birth Center

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05845879
Collaborator
(none)
200
12

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: delivery

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Obstetrical Outcomes for Planned Deliveries in a French Birth Center
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Women who planned to deliver at the brith center "un nid pour naître"

Women who planned to deliver at the brith center "un nid pour naître"

Other: delivery
delivery

Outcome Measures

Primary Outcome Measures

  1. 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). [4 years]

    rate of cesarean section

  2. 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). [4 years]

    rate of instrumental birth (vacuum or forceps delivery)

  3. 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). [4 years]

    rate of post-partum haemorrhage define by blood loss >= 500 cc

Secondary Outcome Measures

  1. 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). [4 years]

  2. 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). [4 years]

  3. 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). [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. 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). [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • women who want to deliver at the birth center "Un nid pour naître"
Exclusion Criteria:
  • Refusal to participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthieu DAP, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05845879
Other Study ID Numbers:
  • 2022PI173
First Posted:
May 6, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 10, 2023