An interventional study of Classic information and Information by detailed brochure on the fetal active movements account in Prolonged Pregnancy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention
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.
30 studies on the registry are indexed under Pregnancy, Prolonged; 2 are open to participants now.
This study's enrollment of 278 is above the median of 132 across 23 interventional studies indexed under Pregnancy, Prolonged.
Browse Pregnancy, Prolonged studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who received a classic information.
Procedure: Classic information
Who have been educated to the active fetal movements count.
Procedure: Information by detailed brochure on the fetal active movements account
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.
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).
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
Time frame: At the delivery.
Number of consultations
Number of consultations with the sensation of decrease active fetal movements.
Time frame: 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).
Time frame: 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.
Time frame: At the delivery.
Mode of labor
Spontaneous or induction of labor, and explications for induction.
Time frame: At the delivery.
Childbirth
Caesarean, spontaneous outcome, assisted vaginal outcome.
Time frame: At the delivery.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire de Saint Etienne