NCT05845879

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

April 9, 2023

Last Update Submit

May 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

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

    4 years

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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

Interventions

delivery

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

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Parturition

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2023

First Posted

May 6, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

May 1, 2024

Last Updated

May 23, 2023

Record last verified: 2023-05