Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation

NCT06480916 | Recruiting

• 1 other identifier: 2024-04Obs-CHRMT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

It is an observational, descriptive, prospective, multicenter study of 8 maternity units in Lorraine and Champagne-Ardenne, aimed at comparing the percentage of "avoidable" maternal-fetal transfers (MFTs), defined as transfers in which the delivery finally meets the acceptance criteria of the sending maternity unit, according to the obstetrical indications for these MFTs.

Conditions

Maternal-Fetal Relations

Keywords

maternal-fetal transfer; care organization; patient pathway; maternity hospital

Outcome Measures

Primary Outcomes (1)

• The percentage of "avoidable" maternal-foetal transfer (MFT)

  The main evaluation criterion is "avoidable" maternal-foetal transfer (MFT), i.e. resulting in a delivery that met the acceptance criteria of the original maternity hospital

  after delivery, up to 6 weeks after the maternal-foetal transfer

Secondary Outcomes (2)

• Obstetrical indication for maternal-foetal transfer (MFT)

  Up to 48 hours after the maternal-foetal transfer

• Organizational arrangements for maternal-foetal transfer

  Up to 6 months after inclusion of a maternity unit in the study

Interventions

Maternal-fetal transfers PROCEDURE

Prospective and consecutive inclusion of all maternal-fetal transfers during the study period. The teams at the sending and receiving maternity units will complete study-related questionnaires to describe the conditions of the transfer and the outcome of the pregnancy. The study in no way alters the way parturients are cared for.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Maternal-fetal transfers (MFTs) for threatened premature delivery

You may qualify if:

• Pregnant woman cared for in a participating maternity unit
• Over 18 years of age
• Requested for maternal-fetal transfer (finally performed, or not)

You may not qualify if:

• missing data on transfer outcome

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (8)

Hopital Maillot

Briey, France

RECRUITING

Maternité CH Léon Bourgeois

Châlons-en-Champagne, France

RECRUITING

CHR Metz Thionville Hopital Femme Mère Enfant

Metz, 57085, France

RECRUITING

Maternité - Hôpital Maurice Camuset

Romilly-sur-Seine, France

RECRUITING

Clinique Saint Nabor

Saint-Avold, France

RECRUITING

Matérnité Saint Dizier

Saint-Dizier, France

RECRUITING

CHR Metz-Thionville Hopital Bel Air

Thionville, France

RECRUITING

Hopital Saint Nicolas

Verdun, France

RECRUITING

Study Officials

• Laetitia HONORE-ROUGE, MD

  CHR Metz Thionville Hopital Femme Mère Enfant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 28, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)