Extra Hospital Delivery Outside Medical Presence. (REGUL-AIpM)

Hôpital NOVO

Status: Completed

Conditions: Delivery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03364517

CHRD1616

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8,208 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8,208 participants in 2 patient groups

Experimental group SPIA

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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