Prolonged PregnancyCOMPTAMAFNCT04117308
Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy.
A study testing Classic information and Information by detailed brochure on the fetal active movements account in people with Prolonged Pregnancy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolonged Pregnancy
- What is being tested?
- Classic information and Information by detailed brochure on the fetal active movements account
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2019to 2 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.
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
- Being tested
- Classic information, Information by detailed brochure on the fetal active movements account
- Keywords
- Perinatal morbidity, Prolonged pregnancy, Fetal active movement count
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic informationProcedure or surgery
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 accountProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients who received a classic information. Receives: Procedure: Classic information |
| Educated group | Experimental | Who have been educated to the active fetal movements count. Receives: Procedure: Information by detailed brochure on the fetal active movements account |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the delivery.
Secondary outcomes (5)
Number of consultations
Number of consultations with the sensation of decrease active fetal movements.
Measured: 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).
Measured: 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.
Measured: At the delivery.
Mode of labor
Spontaneous or induction of labor, and explications for induction.
Measured: At the delivery.
Childbirth
Caesarean, spontaneous outcome, assisted vaginal outcome.
Measured: At the delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start3 Oct 2019
- Primary completion30 Mar 2022
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged PregnancyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine BARJAT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117308
- Sponsor's protocol ID
- 18CH201
- Other IDs
- ANSM
- Acronym
- COMPTAMAF
- Status last verified
- Aug 2021
- First submitted
- 30 Sep 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Use of the Fetal Movement Counting for Prolonged Pregnancy: Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT04117308
- Acronym / sponsor ID
- COMPTAMAF / 18CH201
- Conditions
- Prolonged Pregnancy
- Keywords
- Perinatal morbidity, Prolonged pregnancy, Fetal active movement count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Classic informationPatients who received a classic information. |
| Educated group | Experimental | Procedure: Information by detailed brochure on the fetal active movements accountWho have been educated to the active fetal movements count. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classic informationThe 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. | Procedure or surgery | Control group |
| Information by detailed brochure on the fetal active movements accountDelayed 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). | Procedure or surgery | Educated group |
Primary outcome
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
5 secondary outcomes
Number of consultations
Time frame: At the delivery.
Consultation's delay
Time frame: At the delivery.
Ranking of consultations in 'justified' or 'not justified'
Time frame: At the delivery.
Mode of labor
Time frame: At the delivery.
Childbirth
Time frame: At the delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiphaine BARJAT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic information and Information by detailed brochure on the fetal active movements account in people with Prolonged Pregnancy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of more than 2 criteria of a composite perinatal morbidity score. (time frame: At the delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.