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

June 25, 2024 updated by: Centre Hospitalier Régional Metz-Thionville
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Over the past year, an audit carried out on the Mercy maternity unit, covering 130 transfers to the Nancy regional maternity hospital, showed that patients transferred for threat of premature delivery (MAP) with a cervix > 15 mm do not give birth at the receiving maternity unit, but return home after 48 hours' hospitalization.

When maternal-fetal transfer (MFT) is requested, numerous calls are made to private ambulance services, and in the end, many emergency rapid response units (SMUR) are called out, requiring a major human, logistical and time investment for a questionable benefit to the patient. Tensions in terms of logistics (lack of ambulance, SMUR) and human resources (lack of personnel) can, conversely, compromise good care of the parturient.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Briey, France
        • Recruiting
        • Hopital Maillot
        • Contact:
          • Arpiné EL NAR
        • Principal Investigator:
          • Hayat AALALOU
      • Châlons-en-Champagne, France
        • Recruiting
        • Maternité CH Léon Bourgeois
        • Contact:
          • Arpiné EL NAR
        • Principal Investigator:
          • Aurore Pechereau
      • Metz, France, 57085
      • Romilly-sur-Seine, France
        • Recruiting
        • Maternité - Hôpital Maurice Camuset
        • Contact:
          • Arpiné EL NAR
        • Principal Investigator:
          • Fares GHRAIRI
      • Saint-Avold, France
        • Recruiting
        • Clinique Saint Nabor
        • Contact:
          • Arpiné EL NAR
        • Principal Investigator:
          • Hélène MINEBOIS
      • Saint-Dizier, France
        • Recruiting
        • Matérnité Saint Dizier
        • Contact:
          • Arpiné EL NAR
        • Principal Investigator:
          • Hazem ALGUMAA
      • Thionville, France
      • Verdun, France
        • Recruiting
        • Hopital Saint Nicolas
        • Contact:
          • Arpiné EL NAR
        • Principal Investigator:
          • Fabienne GALLEY-RAULIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Maternal-fetal transfers (MFTs) for threatened premature delivery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • missing data on transfer outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of "avoidable" maternal-foetal transfer (MFT)
Time Frame: after delivery, up to 6 weeks after the maternal-foetal transfer
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstetrical indication for maternal-foetal transfer (MFT)
Time Frame: Up to 48 hours after the maternal-foetal transfer
as documented in the patient file
Up to 48 hours after the maternal-foetal transfer
Organizational arrangements for maternal-foetal transfer
Time Frame: Up to 6 months after inclusion of a maternity unit in the study
Organizational arrangements for maternal-foetal transfer in the various centers, assessed by a specific questionnaire sent to maternity units.
Up to 6 months after inclusion of a maternity unit in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Laetitia HONORE-ROUGE, MD, CHR Metz Thionville Hopital Femme Mère Enfant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-04Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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