Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.

NCT ID: NCT04117308

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-03
• Study Completion Date: 2022-04-02

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.

Conditions

Prolonged Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Patients who received a classic information.

Group Type: ACTIVE_COMPARATOR

Classic information

Intervention Type: PROCEDURE

The team delivers to each patient a unique and standardized information brochure including a definition of fetal active movements, and the need to consult if the patient perceives less the movements of her fetus.

Educated group

Who have been educated to the active fetal movements count.

Group Type: EXPERIMENTAL

Information by detailed brochure on the fetal active movements account

Intervention Type: PROCEDURE

Delayed single and standardized explanatory card on fetal movements (definition, interests of their follow-up, technique of movements on fetuses, table to fill during the follow-up noting the number of active movements physical feelings at 3 times of the day, managing the decrease in the number of active fetal movements).

Interventions

Classic information

The team delivers to each patient a unique and standardized information brochure including a definition of fetal active movements, and the need to consult if the patient perceives less the movements of her fetus.

Intervention Type: PROCEDURE

Information by detailed brochure on the fetal active movements account

Delayed single and standardized explanatory card on fetal movements (definition, interests of their follow-up, technique of movements on fetuses, table to fill during the follow-up noting the number of active movements physical feelings at 3 times of the day, managing the decrease in the number of active fetal movements).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiphaine BARJAT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

18CH201

Identifier Type: -

Identifier Source: org_study_id