Obstetrical Outcomes for Planned Deliveries in a French Birth Center

Delivery Complication Clinical Trial

— NidaModa  

Official title:

Obstetrical Outcomes for Planned Deliveries in a French Birth Center

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05845879
• Other study ID #: 2022PI173
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to participate in the study.

Related Conditions & MeSH terms

• Delivery Complication

Intervention

Other:
• delivery
delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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).	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
Secondary	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