Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04117308
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2019-09-30
Brief Title:
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPTAMAF
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 410 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 AFMs count
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 410 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 AFMs count
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANSM | OTHER | 2019-A00969-48 | None |