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

NCT04117308 | Completed

• 2 other identifiers: 18CH201ANSM
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolonged Pregnancy

Keywords

Perinatal morbidity; Prolonged pregnancy; Fetal active movement count

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of consultations

  At the delivery.

• Consultation's delay

  At the delivery.

• Ranking of consultations in 'justified' or 'not justified'

  At the delivery.

• Mode of labor

  At the delivery.

• Childbirth

  At the delivery.

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients who received a classic information.

Procedure: Classic information

Educated group

EXPERIMENTAL

Who have been educated to the active fetal movements count.

Procedure: Information by detailed brochure on the fetal active movements account

Interventions

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.

Control group

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).

Educated group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tiphaine BARJAT, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 7, 2019
• Study Start: October 3, 2019
• Primary Completion: March 30, 2022
• Study Completion: April 2, 2022
• Last Updated: April 12, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)