Clinical trial NCT03358940: Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage.
Official title: Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage in Guadeloupe.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Threatened Miscarriage
Keywords: Non-medical abortion
Misoprostol
miscarriage complications
Guadeloupe
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 210
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Will be included in the student a patient who is maximum 24 weeks pregnant with miscarriage complications or not, or threatened miscarriage, or voluntary termination of pregnancy using misoprostol.
Primary purpose: DIAGNOSTIC

Brief summary: Non-medical used of misoprostol for abortion is a growing concern in Guadeloupe. Such situation is reasonable for countries in which abortion is not easy to obtain or prohibited. However regarding the risk of complications, it is less understandable in region like Guadeloupe where legal abortion with medical assistance is accessible for all and free.

The aim of the study is to investigate on the amount of misoprostol taken by women in Guadeloupe, by doing an analytical measurement. The aim is to evaluate batter this practice in Guadeloupe, when the main objective of the study is to detect the presence or the absence of misoprostol in the urine sample of the woman coming at hospital for threatened miscarriage or miscarriage complications. Moreover, these abortions can be more important than spontaneous miscarriage.

Detailed description: Previous assessments in many countries as well in Guadeloupe were based on self-declaration. Such assessment is suspected to lead to underestimation. In addition, to our knowledge, no comparison has been done between those induced abortions and the natural miscarriages.

Illegal aspects of non-medical use of misoprostol and consequently bad self-declaration are hindrance to good assessment of the burden of such practice among patients asking for medical care at emergency unit for miscarriage or threatened miscarriage. They may also impair quality of evaluation of the relative risk associated to miscarriage threatened miscarriage induced by misoprostol compared to the same obstetrical complication without absorption of misoprostol. After a dose, misoprostol is quickly active and metabolised. It is mainly eliminated in urine. This elimination seems to be a way to increase the length of detection of the use of misoprostol. The aim of our study is to perform a detection of misoprostol in urine sample of patients hospitalised for a miscarriage or threatened miscarriage. This sample will be done during emergency cares. The study will not change the procedure of medical care of the patients during or after hospitalisation. All data will be obtained from information and result of tests normally done in such situation.

Eligibility criteria: Inclusion Criteria:

* inclusion criteria:
* All patients who come at the maternity emergency unit for miscarriage or threatened miscarriage by 24 weeks of amenorrhea or patient receiving misoprostol for voluntary abortion.
* Age ≥ 12 years old
* Patient insured under the French social security system

Exclusion Criteria:

* Refusal to participate in the study
* Age \< 12 years old

Primary outcomes:
measure: Detection of misoprostol in urine sample
timeFrame: Enrollment visit
Secondary outcomes:
measure: sociodemographic feature of patient and medical outcomes of the miscarriage or threatened miscarriage.
timeFrame: Enrollment visit
Other outcomes:
Locations:
Study officials:
affiliation: Hospital University Center of Pointe-à-Pitre
name: Philippe KADHEL, medicine degree, gynecology
role: PRINCIPAL_INVESTIGATOR
References: