Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.
- Conditions
- Prolonged Pregnancy
- Interventions
- Procedure: Information by detailed brochure on the fetal active movements accountProcedure: Classic information
- Registration Number
- NCT04117308
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 278
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Educated group Information by detailed brochure on the fetal active movements account Who have been educated to the active fetal movements count. Control group Classic information Patients who received a classic information.
- Primary Outcome Measures
Name Time Method The presence of more than 2 criteria of a composite perinatal morbidity score. 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
- Secondary Outcome Measures
Name Time Method Number of consultations At the delivery. Number of consultations with the sensation of decrease active fetal movements.
Mode of labor At the delivery. Spontaneous or induction of labor, and explications for induction.
Ranking of consultations in 'justified' or 'not justified' At the delivery. Ranking of consultations in 'justified' or 'not justified' is depending on the result of the complementary examinations practiced (Ultrasound with Manning score, kleihauer test). A consultation for reduction of fetal active movements is considered justified if presence of abnormal fetal heart rate and / or Manning score less than 8/8 and / or positive kleihauer test.
Consultation's delay At the delivery. Consultation's delay in relation with the sensation of decrease active fetal movements (classified on \<12 hours or \>12hours).
Childbirth At the delivery. Caesarean, spontaneous outcome, assisted vaginal outcome.
Trial Locations
- Locations (1)
Chu Saint-Etienne
🇫🇷Saint-Étienne, France