Extra Hospital Delivery Outside Medical Presence.

Delivery Clinical Trial

— REGUL-AIpM  

Official title:

Evaluation of a Standardized Medical Regulation Strategy on the Reduction of Deliveries Outside Medical Presence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364517
• Other study ID #: CHRD1616
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: December 14, 2021

Study information

• Verified date: August 2022
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8208
• Est. completion date: December 14, 2021
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delivery

Intervention

Other:
• 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).

Locations

Country	Name	City	State
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 René-DUBOS	Cergy-pontoise
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of deliveries outside maternity.	This is the number of deliveries that took place outside the maternity ward. For the included participants, the investigators divide the number of deliveries that took place outside the maternity ward by the number of births that took place in the maternity ward. It is then sufficient to multiply the result by one hundred to obtain the percentage that the investigators wish to measure.	Through study completion, an average of eighteen months.
Secondary	Number of adapted responses.	It is the number of patients who have obtained a response adapted to their condition, that is to say the provision of resources corresponding to the recommendations in relation to the expected delay until delivery.	Through study completion, an average of eighteen months.
Secondary	Duration of the call collected on the regulation.	The investigators measure the duration in minutes of the call collected on the regulation file before sending the appropriate means to the state of the participant. This is the time in minutes between the time the investigator takes the call and the time the decision is made.	At the moment of inclusion of the patient, an average one day.
Secondary	Regulatory investigator satisfaction by a standardized questionnaire.	This consists of measuring the satisfaction of the investigator by a standardized questionnaire for the study. This questionnaire contains only one question: what is the difficulty you had in making the regulatory decision? Then just check the corresponding box. These boxes are ten in number. The zero box corresponds to no difficulty in making the decision and box 10 corresponds to the maximum difficulty in making the decision.	Through study completion, an average of six months.
Secondary	APGAR scores of newborn at birth and 10 minutes of delivery.	The APGAR score is used to assess the condition of a newborn. It is measured once at birth and a second time ten minutes after delivery. The optimal state of the baby gives a score equal to ten. The apparent state of death is zero side. It allows investigators to determine the course of action and the surveillance elements of each newborn. A score between seven and ten consists of a conduct of the investigators that will be mild and will consist of a simple unclogging of the airways and an optional oxygen supply. A score between four and seven will consist of serious care that is needed and in the absence of rapid improvement the child will be unblocked, receive oxygen in the mask and be infused. Finally, a score lower than four will lead to intensive resuscitation maneuvers that will be undertaken and in the absence of dramatic improvement the child will be transferred to a resuscitation unit.	At one minute then at ten minutes.
Secondary	Vital status of mother and newborn (at 3 days).	This is to collect the vital status of the mother and newborn three days after delivery.	Three days after delivery.
Secondary	Number of hypothermia, hypoglycemia, respiratory and circulatory distress, hospitalizations in intensive care-neonatology, among newborns.	The investigators collect the number of newborns who have experienced episodes of hypothermia, hypoglycemia, respiratory and circulatory distress and hospitalizations in intensive care-neonatology.	An average of one month after delivery.