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Medical Abortion With Single Daily Dose of Misoprostol

Primary Purpose

Miscarriage

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Maternal age more than 18 years old (age of legal consent).
  • Gestational age less than 13 weeks.
  • Hemoglobin >10 g/dL.
  • BMI between 25 kg/m2 and 35 kg/m2.
  • Missed abortion.
  • Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

  • Maternal age less than 18 years old.
  • Gestational age more than 12 weeks.
  • Hemoglobin <10 g/dL.
  • Anencephaly.
  • Fibroid uterus.
  • BMI less than 25kg/m2 and more than 35kg/m2.
  • Coagulopathy.
  • History or evidence of adrenal pathology.
  • Previous attempts for induction of abortion in the current pregnancy.
  • Allergy to misoprostol or letrozole.
  • Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single daily dose

Multiple daily doses

Arm Description

Outcomes

Primary Outcome Measures

Complete miscarriage
Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage

Secondary Outcome Measures

Full Information

First Posted
March 25, 2018
Last Updated
January 26, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03487354
Brief Title
Medical Abortion With Single Daily Dose of Misoprostol
Official Title
Medical Abortion With Multiple vs Single Daily Dose of Misoprostol in First Trimester Miscarriage: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single daily dose
Arm Type
Active Comparator
Arm Title
Multiple daily doses
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Misoprostol
Primary Outcome Measure Information:
Title
Complete miscarriage
Description
Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage
Time Frame
one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Maternal age more than 18 years old (age of legal consent). Gestational age less than 13 weeks. Hemoglobin >10 g/dL. BMI between 25 kg/m2 and 35 kg/m2. Missed abortion. Living fetus with multiple congenital malformations incompatible with life. Exclusion Criteria: Maternal age less than 18 years old. Gestational age more than 12 weeks. Hemoglobin <10 g/dL. Anencephaly. Fibroid uterus. BMI less than 25kg/m2 and more than 35kg/m2. Coagulopathy. History or evidence of adrenal pathology. Previous attempts for induction of abortion in the current pregnancy. Allergy to misoprostol or letrozole. Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Medical Abortion With Single Daily Dose of Misoprostol

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