- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406776
Identification of Histories of Pregnancy Termination, Particularly Early Miscarriage, in General Medical Records
Early miscarriage (EM) is defined as the spontaneous expulsion of an intrauterine pregnancy of less than 14 weeks' duration. Early miscarriage is a very common complication, affecting more than 10% of pregnancies. Because of its frequency, EM is often considered a trivial event, particularly by healthcare professionals.
However, for the women who experience it, EM can be a traumatic event, difficult to discuss with their families, and a source of worries and questions for subsequent pregnancies. The international literature is consistent on the psychological morbidity associated with miscarriage: anxiety, depression and post-traumatic stress disorder have been studied in women following CPT. The identification of a history of EM by doctors is therefore important for the overall management of women's health.
The 2021 National Perinatal Survey showed that less than 5% of pregnant women in France had their first six months of pregnancy monitored by a general practitioner, a proportion that has been steadily declining in recent years. The majority of women are monitored by a gynecologist, or in 40% of cases by a midwife. These professionals therefore appear to be the preferred point of contact for women in the event of a miscarriage. In the absence of specific information, either from the woman herself or from the healthcare professional who treated her, the general practitioner-the attending physician may remain unaware of this event in their patient's life. Under these circumstances, identifying a history of EM in the general practitioner's medical records may not be sufficient.
Study Overview
Status
Conditions
Detailed Description
The primary objective is to describe the frequency of notification of a history of early miscarriage in the treating physician's medical record.
The secondary objectives are :
- To describe how the treating physician is informed of the history of early miscarriage.
- To investigate the factors associated with notification of a history of early miscarriage in the treating physician's medical record medical records.
- Describe the frequency of notification of a history of termination of pregnancy other than early miscarriage (voluntary termination of pregnancy, foetal death in utero, medical termination of pregnancy) in the treating physician's medical record.
- Describe the procedures for informing the attending doctor about the history of termination of pregnancy other than early miscarriage.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Champagne-Ardenne
-
Reims, Champagne-Ardenne, France, 51100
- Gestonnairedu CURRS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female
- Aged between 18 and 50
- Whose GP has agreed to take part in the study
- Agreeing to take part in the study.
Exclusion Criteria:
- Minors
- Over the age of 50
- Protected by law (guardianship, curatorship, safeguard of justice)
- Refusing to take part in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
notification of early miscarriage in the medical file of the woman who reported it.
Time Frame: Day 0
|
the frequency of notification of a history of early miscarriage in the attending physician's medical records.
|
Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024_RIPH_07_DMG-Fausse couche
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Early Miscarriage
-
Pakistan Air Force (PAF) Hospital IslamabadCompletedEarly Pregnancy Bleeding | Threatened MiscarriagePakistan
-
Assistance Publique - Hôpitaux de ParisRecruitingMiscarriage | Early Pregnancy LossFrance
-
University of PennsylvaniaRecruitingMiscarriage | Early Pregnancy Loss | Miscarriage in First TrimesterUnited States
-
Fayoum University HospitalCompleted
-
Boston UniversityTerminatedMiscarriage | Fetal Demise | Early Pregnancy Failure | Anembryonic PregnancyUnited States
-
University Hospital, AngersDirection Générale de l'Offre de SoinsRecruitingEarly Pregnancy Loss | Spontaneous MiscarriageFrance
-
Konya Meram State HospitalNot yet recruiting
-
Ain Shams UniversityCompletedThreatened Miscarriage in First Trimester
-
Ain Shams UniversityCompletedComplete MiscarriageEgypt
-
Fudan UniversityUnknown