Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

April 23, 2024 updated by: Mohammed Khairy Ali, Assiut University

Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.

The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • single dead fetus up-to 12 weeks.
  • no low lying placenta
  • no scarred uterus
  • no or mild bleeding
  • no evidence of infection
  • accepting to participate in the study.

Exclusion Criteria:

  • Advanced hepatic diseases .
  • Suspected molar pregnancy
  • Ectopic pregnancy or pregnancy of unknown location
  • Haemodynamically unstable with significant anaemia ie Hb<10
  • Uncontrolled severe asthma
  • Chronic adrenal failure
  • Known or suspected heart disease
  • Glaucoma
  • Haemoglobinopathies
  • Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
  • Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
  • Patient living in remote areas with difficulty in accessing hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hospital- based vaginal misoprostol
Drug: vaginal misoprostol
(800µgm.x 2 doses 3 hours).
Other Names:
  • buccal/sublingual misoprostol
Active Comparator: extended low dose oral misoprostol
Drug: buccal/sublingual misoprostol
200 µgm.x4 hrs.x 6 doses
Other Names:
  • vaginal misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with complete abortion (success rate).
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of misoprostol doses
Time Frame: 1 week
1 week
induction-abortion time
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VMIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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