Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- The presence of more than 2 criteria of a composite perinatal morbidity score.
研究概览
简要总结
Prospective mono-centric randomized open-label study (randomization 1: 1, 2 groups) comparing a group of patients who received conventional information to a group of patients who had been sensitized to a fetal active movement count technique.
The study will take place at the University Hospital Center of Saint-Etienne in the gynecology-obstetrics department.
An information brochure on the study will be handed over at the end of the term consultation to 41+0 weeks of gestation. After collecting the consent of the patient, the distribution between the two groups will be done by randomization. Thus, for the fetal active movement count group, fetal active movement count education will be proposed during the term consultation with the submission of an information brochure. The "control" group will also receive a simple information pamphlet with, in writing, what patients currently receive orally: definition of active fetal movements, and the need to consult if the patient perceives less movements of her fetus .The principal objective is to compare perinatal morbidity in relation with the sensation of decrease active fetal movements in case of late pregnancy, according to the fact if the patients use or not the AFM's count.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Any pregnant woman presenting herself in the Gynecology-obstetrics Department of the hospital of Saint-Etienne during the term consultation at 41 weeks of amenorrhea + 0 day.
- •Non pathological Singleton Pregnancy except for balanced gestational diabetes
- •Patient affiliated with or entitled to a Social security plan
- •Patients who have given their participation agreement and signing the consent
排除标准
- •Woman refusing to participate in the study (lack of consent)
- •Non-francophone woman (and / or enable + read french)
- •Woman making a maternity change for childbirth (risk of follow-up bias)
- •Pathological pregnancy
- •Participation to another interventional study.
- •Patient subject to legal protection or unable to express consent
- •Patient who has already benefited from an awareness of the AFM's account
结局指标
主要结局
The presence of more than 2 criteria of a composite perinatal morbidity score.
时间窗: At the delivery.
The primary outcome will be the presence of more than 2 criteria of a composite perinatal morbidity score: * Fetal heart rate anomaly during childbirth. * Apgar \< 7 at 5 minutes * Cord arterial Ph \< 7.20 * Acute respiratory distress with the need for surveillance in neonatal resuscitation
次要结局
- Number of consultations(At the delivery.)
- Mode of labor(At the delivery.)
- Ranking of consultations in 'justified' or 'not justified'(At the delivery.)
- Childbirth(At the delivery.)
- Consultation's delay(At the delivery.)