Observatory of Unintentional Births Hospital Extras (AIEH34)

Observatory of Unintentional Births Hospital Extras in Hérault

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.

Study Overview

• Status: Unknown
• Conditions: Unexpected Delivery Outside Maternity

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 Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Christelle GRAF, wise woman; Phone Number: 33 0677696194; Email: c-graf@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Christelle GRAF, wise woman; Phone Number: 33 0677696194; Email: c-graf@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Unexpected delivery outside maternity in the Hérault department

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of medicalization

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of unexpected hospital deliveries (AIE)	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	DAY 0 TO DAY 7 TO DELIVRERY

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: SDIS34 - MONTPELLIER; SAMU CHU Montpellier
• Investigators: Principal Investigator: Christelle GRAF, wise woman, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: obstetrics; pre-hospital emergencies unannounced delivery outside maternity,; mortality-morbidity; reinforcement midwife in pre-hospital
• Other Study ID Numbers: RECHMPL18_0442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No