Skip to main content
OpenTrials
Completed

NCT Number: NCT04117308

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prolonged Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Prolonged Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. The presence of more than 2 criteria of a composite perinatal morbidity score.

    Time frame: At the delivery.

    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 outcomes

  1. Number of consultations

    Time frame: At the delivery.

    Number of consultations with the sensation of decrease active fetal movements.

  2. Consultation's delay

    Time frame: At the delivery.

    Consultation's delay in relation with the sensation of decrease active fetal movements (classified on <12 hours or >12hours).

  3. Ranking of consultations in 'justified' or 'not justified'

    Time frame: At the delivery.

    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.

  4. Mode of labor

    Time frame: At the delivery.

    Spontaneous or induction of labor, and explications for induction.

  5. Childbirth

    Time frame: At the delivery.

    Caesarean, spontaneous outcome, assisted vaginal outcome.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: COMPTAMAF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2019
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.