Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage.

NCT03358940 | Completed DMC

• 1 other identifier: RBM-PAP-2015/31
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Threatened Miscarriage

Keywords

Non-medical abortion; Misoprostol; miscarriage complications; Guadeloupe

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment visit

Secondary Outcomes (1)

• sociodemographic feature of patient and medical outcomes of the miscarriage or threatened miscarriage.

  Enrollment visit

Study Arms (1)

patient with miscarriage complications or not

OTHER

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.

Other: urine collection

Interventions

urine collection OTHER

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.

patient with miscarriage complications or not

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: Only pregnant women can be included in the study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Philippe KADHEL, medicine degree, gynecology

  Hospital University Center of Pointe-à-Pitre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: March 29, 2016
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share