Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage. (MISO)
Primary Purpose
Threatened Miscarriage
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
urine collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Threatened Miscarriage focused on measuring Non-medical abortion, Misoprostol, miscarriage complications, Guadeloupe
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient with miscarriage complications or not
Arm Description
The day of inclusion, for patient with miscarriage complications or not, or threatened miscarriage there will be a urine collection. In case of hospitalization, another urine collection will be done between 12 and 18 hours after the inclusion. For patient coming for voluntary termination of pregnancy using misoprostol, a urine collection will be done the day of the inclusion and another ones 1, 4, 12 and 24 hours after the inclusion.
Outcomes
Primary Outcome Measures
Detection of misoprostol in urine sample
A descriptive analysis of variable is planned. And comparison between exposed or non-exposed to misoprostol will be done. Uni and multivariate linear regression will be used for analyse associated risk of misoprostol use.
Secondary Outcome Measures
sociodemographic feature of patient and medical outcomes of the miscarriage or threatened miscarriage.
A descriptive analysis of variable is planned. And comparison between exposed or non-exposed to misoprostol will be done. Uni and multivariate linear regression will be used for analyse associated risk of misoprostol use.
Full Information
NCT ID
NCT03358940
First Posted
November 27, 2017
Last Updated
December 4, 2017
Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
1. Study Identification
Unique Protocol Identification Number
NCT03358940
Brief Title
Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage.
Acronym
MISO
Official Title
Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage in Guadeloupe.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 29, 2016 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Miscarriage
Keywords
Non-medical abortion, Misoprostol, miscarriage complications, Guadeloupe
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with miscarriage complications or not
Arm Type
Other
Arm Description
The day of inclusion, for patient with miscarriage complications or not, or threatened miscarriage there will be a urine collection. In case of hospitalization, another urine collection will be done between 12 and 18 hours after the inclusion. For patient coming for voluntary termination of pregnancy using misoprostol, a urine collection will be done the day of the inclusion and another ones 1, 4, 12 and 24 hours after the inclusion.
Intervention Type
Other
Intervention Name(s)
urine collection
Intervention Description
For patient with miscarriage complications or not, or threatened miscarriage there will be a urine collection the day of the inclusion. In case of hospitalization, another urine collection will be done between 12 and 18 hours after the inclusion. For patient coming for voluntary termination of pregnancy using misoprostol, a urine collection will be done the day of the inclusion and another ones 1, 4, 12 and 24 hours after the inclusion.
Primary Outcome Measure Information:
Title
Detection of misoprostol in urine sample
Description
A descriptive analysis of variable is planned. And comparison between exposed or non-exposed to misoprostol will be done. Uni and multivariate linear regression will be used for analyse associated risk of misoprostol use.
Time Frame
Enrollment visit
Secondary Outcome Measure Information:
Title
sociodemographic feature of patient and medical outcomes of the miscarriage or threatened miscarriage.
Description
A descriptive analysis of variable is planned. And comparison between exposed or non-exposed to misoprostol will be done. Uni and multivariate linear regression will be used for analyse associated risk of misoprostol use.
Time Frame
Enrollment visit
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only pregnant women can be included in the study.
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe KADHEL, medicine degree, gynecology
Organizational Affiliation
Hospital University Center of Pointe-à-Pitre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage.
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