Medical Abortion With Single Daily Dose of Misoprostol

NCT ID: NCT03487354

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-01-10

Brief Summary

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

Detailed Description

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Conditions

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Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single daily dose

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Misoprostol

Multiple daily doses

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Misoprostol

Interventions

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Misoprostol

Misoprostol

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1753

Identifier Type: -

Identifier Source: org_study_id

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