search
Back to results

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
Centre Hospitalier Universitaire de Pointe-a-Pitre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Threatened Miscarriage focused on measuring Non-medical abortion, Misoprostol, miscarriage complications, Guadeloupe

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    November 27, 2017
    Last Updated
    December 4, 2017
    Sponsor
    Centre Hospitalier Universitaire de Pointe-a-Pitre
    search

    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.

    We'll reach out to this number within 24 hrs