NCT03364517

Extra Hospital Delivery Outside Medical Presence.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,208 (actual)
• Sponsor: Hôpital NOVO · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-03-14
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2017-12-06
• Last updated: 2024-09-19

Locations

19 sites across 1 country: France