Evaluation of a Standardized Medical Regulation Strategy on the Reduction of Deliveries Outside Medical Presence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,208
- 试验地点
- 38
- 主要终点
- Number of deliveries without the presence of a doctor or midwife and absence of the SMUR sent in first intention.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Opposition of the patient after sending the information note.
结局指标
主要结局
Number of deliveries without the presence of a doctor or midwife and absence of the SMUR sent in first intention.
时间窗: Through study completion, an average of eighteen months.
It will be the number of unexpected deliveries out of medical presence.
次要结局
- Regulatory investigator satisfaction by a standardized questionnaire.(Through study completion, an average of six months.)
- Duration of the call collected on the regulation.(At the moment of inclusion of the patient, an average one day.)
- Number of hypothermia, hypoglycemia, respiratory and circulatory distress, hospitalizations in intensive care-neonatology, among newborns.(An average of one month after delivery.)
- Number of deliveries outside maternity.(Through study completion, an average of eighteen months.)
- Number of adapted responses.(Through study completion, an average of eighteen months.)
- Vital status of mother and newborn (at 3 days).(Three days after delivery.)
- APGAR scores of newborn at birth and 10 minutes of delivery.(At one minute then at ten minutes.)