Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy. (COMPTAMAF)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Prolonged Pregnancy

Treatments: Procedure: Classic information; Procedure: Information by detailed brochure on the fetal active movements account

Study type: Interventional

Funder types: Other

Identifiers

NCT04117308

18CH201

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 278 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

Control group

Active Comparator group

Description:

Patients who received a classic information.

Treatment:

Procedure: Classic information

Educated group

Experimental group

Description:

Who have been educated to the active fetal movements count.

Treatment:

Procedure: Information by detailed brochure on the fetal active movements account