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

N/ACompletedNCT04117308
Centre Hospitalier Universitaire de Saint Etienne278 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

278

Conditions

Prolonged Pregnancy

Interventions

Classic informationPROCEDURE

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.

Information by detailed brochure on the fetal active movements accountPROCEDURE

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).

Eligibility

Sex: FEMALEMin age: 18 Years
Medical Language ↔ Plain English
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

Locations (1)

Chu Saint-Etienne

Saint-Etienne, France

Outcomes

Primary Outcomes

The presence of more than 2 criteria of a composite perinatal morbidity score.

The primary outcome will be the presence of more than 2 criteria of a composite perinatal morbidity score: * Fetal heart rate anomaly during childbirth. * Apgar \< 7 at 5 minutes * Cord arterial Ph \< 7.20 * Acute respiratory distress with the need for surveillance in neonatal resuscitation

Time frame: At the delivery.

Secondary Outcomes

Number of consultations

Number of consultations with the sensation of decrease active fetal movements.

Time frame: At the delivery.

Consultation's delay

Consultation's delay in relation with the sensation of decrease active fetal movements (classified on \<12 hours or \>12hours).

Time frame: At the delivery.

Ranking of consultations in 'justified' or 'not justified'

Ranking of consultations in 'justified' or 'not justified' is depending on the result of the complementary examinations practiced (Ultrasound with Manning score, kleihauer test). A consultation for reduction of fetal active movements is considered justified if presence of abnormal fetal heart rate and / or Manning score less than 8/8 and / or positive kleihauer test.

Time frame: At the delivery.

Mode of labor

Spontaneous or induction of labor, and explications for induction.

Time frame: At the delivery.

Childbirth

Caesarean, spontaneous outcome, assisted vaginal outcome.

Time frame: At the delivery.

Data from ClinicalTrials.gov

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