Extra Hospital Delivery Outside Medical Presence.

NCT ID: NCT03364517

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2021-12-14

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.

Detailed Description

This study aims to evaluate a standardized procedure of medical regulation based on a validated predictive score of eminent delivery (SPIA) in comparison with usual inhomogeneous practices. It will therefore focus on the issues of medical regulation at SAMU - Center 15. The goal of the regulator is to provide the right care in situations of constrained medical resources, that is to say the need to bring the right answer in the most appropriate time and to direct the parturient in the structure which is the most adapted. Currently, very few studies are conducted in this area. However, maternal and fetal morbidity out off medical presence exists and deserves special attention. Unexpected childbirth outside a maternity ward is an emergency for the mother and the child, with maternal-fetal excess mortality 2 to 3 times higher. In this area, the modalities of response to the call - after assessment by the regulator of the foreseeable delay of delivery - are very unequal in France. The hypothesis of this study is that a decision-making aid using score SPIA will provide better management by reducing the risk of delivery without the presence of a doctor or midwife.

The expected benefits for the patients are a decrease in the maternal-fetal morbidity and mortality, an adapted orientation of the patient according to the foreseeable delay before delivery. This is to avoid the patient's referral to a maternity ward that is not her own when it is not necessary - that is, an orientation in a maternity ward that is inappropriate for her condition and / or with a risk of delivery outside maternity. Finally, another expected benefit is the patient delivery in the presence of a doctor and / or midwife.

The expected benefits for public health are an adapted sending of means, principle of the "just care" and the good use of the medical resources, to avoid the situations of deficiency of SMUR following an inappropriate sending (accessibility of the offer of care) and improved practices, without additional cost to public health (improve the efficiency of the UAS regulation - Center 15).

Conditions

Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group SPIA

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.

Group Type: EXPERIMENTAL

Predictor score of the imminence of a childbirth (SPIA)

Intervention Type: 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).

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Predictor score of the imminence of a childbirth (SPIA)

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Opposition of the patient after sending the information note.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnès RICARD-HIBON

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

Centre Hospitalier René-DUBOS

Cergy-Pontoise, Cergy-pontoise, France

Centre Hospitalier Universitaire d'Amiens

Amiens, , France

Centre Hospitalier Régional Universitaire de Besançon

Besançon, , France

Centre Hospitalier Universitaire Avicenne

Bobigny, , France

Hôpital Pellegrin

Bordeau, , France

Centre Hospitalier Henri Mondor

Créteil, , France

Centre Hospitalier Universitaire de Dijon

Dijon, , France

Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Hôpital André Mignot

Le Chesnay, , France

Centre Hospitalier Régional Universitaire de Lille

Lille, , France

Groupement Hospitalier Edouard Herriot

Lyon, , France

Centre Hospitalier Marc Jacquet

Melun, , France

Centre Hospitalier Régional Mets-Thionville

Metz, , France

Centre Hospitalier Annecy-Genevois

Metz-Tessy, , France

Centre Hospitalier Universitaire de Nancy

Nancy, , France

Centre Hospitalier Universitaire de Rennes

Rennes, , France

Centre Hospitalier Universitaire de la Réunion

Saint-Denis, , France

Centre Hospitalier de Toulon

Toulon, , France

Hôpital Purpan

Toulouse, , France

Countries

France

Other Identifiers

CHRD1616

Identifier Type: -

Identifier Source: org_study_id