Extra Hospital Delivery Outside Medical Presence.

NCT03364517 | Completed

• 1 other identifier: CHRD1616
• Study Type: interventional
• Target: 8,208
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of this study is to prospectively evaluate a standardized procedure of medical regulation based on a validated predictive score of eminent delivery (SPIA) in comparison with usual inhomogeneous practices. This standardized procedure impacting the process of care production (when receiving the call for regulation for unannounced delivery) would improve the quality of care of parturients while rationalizing the use of medical teams in the field.

Conditions

Delivery

Keywords

Medical regulation; SPIA; Imminent delivery

Outcome Measures

Primary Outcomes (1)

• Number of deliveries without the presence of a doctor or midwife and absence of the SMUR sent in first intention.

  It will be the number of unexpected deliveries out of medical presence.

  Through study completion, an average of eighteen months.

Secondary Outcomes (7)

• Number of deliveries outside maternity.

  Through study completion, an average of eighteen months.

• Number of adapted responses.

  Through study completion, an average of eighteen months.

• Duration of the call collected on the regulation.

  At the moment of inclusion of the patient, an average one day.

• Regulatory investigator satisfaction by a standardized questionnaire.

  Through study completion, an average of six months.

• APGAR scores of newborn at birth and 10 minutes of delivery.

  At one minute then at ten minutes.

Study Arms (2)

Experimental group SPIA

EXPERIMENTAL

The regulator will be asked to systematically use the tool Predictor score of the imminence of a childbirth (SPIA). This tool is used to evaluate the means to be sent following a call for imminent delivery outside the hospital.

Other: Predictor score of the imminence of a childbirth (SPIA)

Control group

NO INTERVENTION

The classic care will be made according to the usual practices of the doctor and the center.

Interventions

Predictor score of the imminence of a childbirth (SPIA) OTHER

The SPIA score is based on the analysis of 6 types of criteria: panic during the call, the possibility of having a telephone contact with the parturient, the urge to push and if so for how long, the rhythm of the CU, some aggravating factors (history of fast delivery or at home, maternal age between 26 and 35 years, lack of follow-up of pregnancy) and 2 minor factors (nulliparity and the taking of a tocolytic treatment). Each criteria is between 0 to 8, except for the 2 minor criteria for which 7 and 3 points are removed if they are present. This gives a score between -10 and +33, which is weighted according to the admission time estimated at the hospital (30 minutes, 1h and 2h).

Experimental group SPIA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman over 33 WA
• Age ≥ 18 years
• Calling the regulation of SAMU-Center 15 for start of work
• Patient not planning to give birth at home
• Delivery not having started at the time of the first call (hair, head, buttocks or feet not visible)
• Absence of a doctor, obstetrician or midwife on the spot during the call
• French language included (Patient and / or Near)

You may not qualify if:

• Opposition of the patient after sending the information note.

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (19)

Centre Hospitalier René-DUBOS

Cergy-Pontoise, Cergy-pontoise, 95303, France

Location

Centre Hospitalier Universitaire d'Amiens

Amiens, 80080, France

Location

Centre Hospitalier Régional Universitaire de Besançon

Besançon, 25000, France

Location

Centre Hospitalier Universitaire Avicenne

Bobigny, 93000, France

Location

Hôpital Pellegrin

Bordeau, 33000, France

Location

Centre Hospitalier Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21000, France

Location

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38700, France

Location

Hôpital André Mignot

Le Chesnay, 78150, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59000, France

Location

Groupement Hospitalier Edouard Herriot

Lyon, 69003, France

Location

Centre Hospitalier Marc Jacquet

Melun, 77011, France

Location

Centre Hospitalier Régional Mets-Thionville

Metz, 57000, France

Location

Centre Hospitalier Annecy-Genevois

Metz-Tessy, 74370, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, 54000, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Centre Hospitalier Universitaire de la Réunion

Saint-Denis, 97400, France

Location

Centre Hospitalier de Toulon

Toulon, 83056, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

Study Officials

• Agnès RICARD-HIBON

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled cluster study.

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 6, 2017
• Study Start: March 14, 2018
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: September 19, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)