Clinical trial NCT03364517: Extra Hospital Delivery Outside Medical Presence.
Official title: Evaluation of a Standardized Medical Regulation Strategy on the Reduction of Deliveries Outside Medical Presence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery
Keywords: Medical regulation
SPIA
Imminent delivery
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 8208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled cluster study.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Number of deliveries without the presence of a doctor or midwife and absence of the SMUR sent in first intention.
timeFrame: Through study completion, an average of eighteen months.
Secondary outcomes:
measure: Number of deliveries outside maternity.
timeFrame: Through study completion, an average of eighteen months.
measure: Number of adapted responses.
timeFrame: Through study completion, an average of eighteen months.
measure: Duration of the call collected on the regulation.
timeFrame: At the moment of inclusion of the patient, an average one day.
measure: Regulatory investigator satisfaction by a standardized questionnaire.
timeFrame: Through study completion, an average of six months.
measure: APGAR scores of newborn at birth and 10 minutes of delivery.
timeFrame: At one minute then at ten minutes.
measure: Vital status of mother and newborn (at 3 days).
timeFrame: Three days after delivery.
measure: Number of hypothermia, hypoglycemia, respiratory and circulatory distress, hospitalizations in intensive care-neonatology, among newborns.
timeFrame: An average of one month after delivery.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Bobigny
country: France
facility: Centre Hospitalier Universitaire Avicenne
city: Bordeau
country: France
facility: Hôpital Pellegrin
city: Cergy-pontoise
country: France
facility: Centre Hospitalier René-DUBOS
city: Créteil
country: France
facility: Centre Hospitalier Henri Mondor
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Le Chesnay
country: France
facility: Hôpital André Mignot
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Lyon
country: France
facility: Groupement Hospitalier Edouard Herriot
city: Melun
country: France
facility: Centre Hospitalier Marc Jacquet
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy-Genevois
city: Metz
country: France
facility: Centre Hospitalier Régional Mets-Thionville
city: Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire de la Réunion
city: Toulon
country: France
facility: Centre Hospitalier de Toulon
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
affiliation: Hôpital NOVO
name: Agnès RICARD-HIBON
role: PRINCIPAL_INVESTIGATOR
References: