Prolonged Pregnancy
Conditions
Keywords
Perinatal morbidity, Prolonged pregnancy, Fetal active movement count
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.
Interventions
PROCEDUREClassic 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.
PROCEDUREInformation 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).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence of more than 2 criteria of a composite perinatal morbidity score. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of consultations | At the delivery. | Number of consultations with the sensation of decrease active fetal movements. |
| Consultation's delay | At the delivery. | Consultation's delay in relation with the sensation of decrease active fetal movements (classified on \<12 hours or \>12hours). |
| Ranking of consultations in 'justified' or 'not justified' | 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. |
| Mode of labor | At the delivery. | Spontaneous or induction of labor, and explications for induction. |
| Childbirth | At the delivery. | Caesarean, spontaneous outcome, assisted vaginal outcome. |
Countries
France
Outcome results
None listed