Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy. (NCT04117308) | Clinical Trial Compass
CompletedNot Applicable
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.
France278 participantsStarted 2019-10-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The presence of more than 2 criteria of a composite perinatal morbidity score.
Timeframe: At the delivery.
Trial details
NCT IDNCT04117308
SponsorCentre Hospitalier Universitaire de Saint Etienne