Clinical trial NCT04117308: Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.
Official title: Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Pregnancy
Keywords: Perinatal morbidity
Prolonged pregnancy
Fetal active movement count
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 278
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, single-center, randomized, open-label study evaluating the use of fetal active movements counts on the perinatal morbidity score in patients with prolonged pregnancy.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The presence of more than 2 criteria of a composite perinatal morbidity score.
timeFrame: At the delivery.
Secondary outcomes:
measure: Number of consultations
timeFrame: At the delivery.
measure: Consultation's delay
timeFrame: At the delivery.
measure: Ranking of consultations in 'justified' or 'not justified'
timeFrame: At the delivery.
measure: Mode of labor
timeFrame: At the delivery.
measure: Childbirth
timeFrame: At the delivery.
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Tiphaine BARJAT, MD
role: PRINCIPAL_INVESTIGATOR
References: