Observatory of Unintentional Births Hospital Extras

• Conditions: Unexpected Delivery Outside Maternity

• Registration Number: NCT03820505
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.

For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.

Detailed Description

As a result, the investigators also found a very high variability in the number of deliveries per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per month (May 2014 example).

Formalized expert recommendations were published in 2010 by SFAR, which then led to the establishment of a national observatory for IEA at the end of 2011, in which the investigators have been participating for 4 years.

Currently the national database lists 2000 unannounced deliveries including 230 in the Hérault.

This observational study allows us to evaluate the management of these patients and newborns, the risks and needs of pre-hospital teams, including the need for reinforcement and expertise of midwives.

The investigators can also assess mortality and morbidity, as well as the extension of hospital stays beyond J7

Study Timeline

• Study Start: 2019-01-23
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Unexpected delivery outside maternity, presence of a medical team during the care

Exclusion Criteria

• Absence of medicalization

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of unexpected hospital deliveries (AIE)	DAY 0 TO DAY 7 TO DELIVRERY	Estimate the impact of non-maternal AIE by the SMUR and the SSM in the department of Héraul, and compare it to the national overall activity

Secondary Outcome Measures

Name	Time	Method
Risks during an unexpected delivery outside maternity	DAY 0 TO DAY 7 POST DELIVRERY	Identify the risks during an unexpected delivery outside maternity
Possible immediate complications during an unexpected delivery outside maternity	DAY 0 TO DAY 7 POST DELIVRERY	Identify the possible immediate complications during an unexpected delivery outside maternity
Method of taking care of unannounced extra hospital deliveries	DAY 0 TO DAY 7 POST DELIVRERY	Method of taking care of unannounced extra hospital deliveries
Difficulties during an unexpected delivery outside maternity	DAY 0 TO DAY 7 POST DELIVRERY	Identify the difficulties during an unexpected delivery outside maternity

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France