Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

August 6, 2021 updated by: Ahmed Mahmoud Emam Ahmed, Cairo University
Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion.

Exclusion Criteria:

  • Patients refused the medical treatment.
  • Patients have contraindications of the drug (Misoprostol).
  • Missed abortion associated with any signs of sepsis

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sublingual Misoprostol for termination of first trimester missed abortion
Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses
Drug: Misoprostol Pill
sublingual versus vaginal Misoprostol in termination of first trimester missed abortion
Active Comparator: Vaginal Misoprostol for termination of first trimester missed abortion
Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses
Drug: Misoprostol Pill
sublingual versus vaginal Misoprostol in termination of first trimester missed abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurance of complete abortion within 24 hours with Misoprostol drug
Time Frame: Within 24 hours
Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
Within 24 hours
Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
Time Frame: within 24 hours
Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion
within 24 hours

Collaborators and Investigators

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

Sponsor

Cairo 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 (Anticipated)

August 3, 2021

Primary Completion (Anticipated)

October 15, 2021

Study Completion (Anticipated)

October 16, 2021

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Misoprostol abortion

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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