Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy. (COMPTAMAF)
Primary Purpose
Prolonged Pregnancy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Classic information
Information by detailed brochure on the fetal active movements account
Sponsored by
About this trial
This is an interventional prevention trial for Prolonged Pregnancy focused on measuring Perinatal morbidity, Prolonged pregnancy, Fetal active movement 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
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Educated group
Arm Description
Patients who received a classic information.
Who have been educated to the active fetal movements count.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of consultations
Number of consultations with the sensation of decrease active fetal movements.
Consultation's delay
Consultation's delay in relation with the sensation of decrease active fetal movements (classified on <12 hours or >12hours).
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.
Mode of labor
Spontaneous or induction of labor, and explications for induction.
Childbirth
Caesarean, spontaneous outcome, assisted vaginal outcome.
Full Information
NCT ID
NCT04117308
First Posted
September 30, 2019
Last Updated
April 11, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT04117308
Brief Title
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.
Acronym
COMPTAMAF
Official Title
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
April 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Pregnancy
Keywords
Perinatal morbidity, Prolonged pregnancy, Fetal active movement count
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients who received a classic information.
Arm Title
Educated group
Arm Type
Experimental
Arm Description
Who have been educated to the active fetal movements count.
Intervention Type
Procedure
Intervention Name(s)
Classic information
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Information by detailed brochure on the fetal active movements account
Intervention Description
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).
Primary Outcome Measure Information:
Title
The presence of more than 2 criteria of a composite perinatal morbidity score.
Description
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 Outcome Measure Information:
Title
Number of consultations
Description
Number of consultations with the sensation of decrease active fetal movements.
Time Frame
At the delivery.
Title
Consultation's delay
Description
Consultation's delay in relation with the sensation of decrease active fetal movements (classified on <12 hours or >12hours).
Time Frame
At the delivery.
Title
Ranking of consultations in 'justified' or 'not justified'
Description
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.
Title
Mode of labor
Description
Spontaneous or induction of labor, and explications for induction.
Time Frame
At the delivery.
Title
Childbirth
Description
Caesarean, spontaneous outcome, assisted vaginal outcome.
Time Frame
At the delivery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiphaine BARJAT, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.
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