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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2019-A00969-48 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients who received a classic information. |
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| Educated group | Experimental | Who have been educated to the active fetal movements count. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classic information | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| At the delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of consultations | Number of consultations with the sensation of decrease active fetal movements. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiphaine BARJAT, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| Information by detailed brochure on the fetal active movements account | 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). |
|
| 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. | At the delivery. |
| Mode of labor | Spontaneous or induction of labor, and explications for induction. | At the delivery. |
| Childbirth | Caesarean, spontaneous outcome, assisted vaginal outcome. | At the delivery. |