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

Prolonged Pregnancy Clinical Trial

— COMPTAMAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117308
• Other study ID #: 18CH201
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: April 2, 2022

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: April 2, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Prolonged
• Prolonged Pregnancy

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of consultations	Number of consultations with the sensation of decrease active fetal movements.	At the delivery.
Secondary	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.
Secondary	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.
Secondary	Mode of labor	Spontaneous or induction of labor, and explications for induction.	At the delivery.
Secondary	Childbirth	Caesarean, spontaneous outcome, assisted vaginal outcome.	At the delivery.