Clinical Trials Directory

Trials / Completed

CompletedNCT04117308

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

Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
278 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREClassic informationThe 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.
PROCEDUREInformation by detailed brochure on the fetal active movements accountDelayed 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).

Timeline

Start date
2019-10-03
Primary completion
2022-03-30
Completion
2022-04-02
First posted
2019-10-07
Last updated
2022-04-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04117308. Inclusion in this directory is not an endorsement.