Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy. (COMPTAMAF)

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

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 Overview

• Status: Completed
• Conditions: Prolonged Pregnancy
• Intervention / Treatment: Procedure: Classic information; Procedure: Information by detailed brochure on the fetal active movements account

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients who received a classic information.	Procedure: Classic information; 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.
Experimental: Educated group; Who have been educated to the active fetal movements count.	Procedure: Information by detailed brochure on the fetal active movements account; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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	At the delivery.

Secondary Outcome Measures

Outcome Measure	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).	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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Tiphaine BARJAT, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2019
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): April 2, 2022

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Perinatal morbidity; Prolonged pregnancy; Fetal active movement count
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Prolonged
• Other Study ID Numbers: 18CH201; ANSM (Other Identifier: 2025-A02220-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No