Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

September 30, 2012 updated by: Hamidreza Mahboobi, Hormozgan University of Medical Sciences

A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009

The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

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

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
        • Hormozgan University of Medical Sciences

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
  • Before 14th week of gestation calculated according LMP or first trimester sonography

Exclusion Criteria:

  • Chorioamnionitis
  • Hypersensitivity to prosstaglandins
  • Past medical history of cardiovascular, kidney or liver or lung diseases
  • Positive history for uterus pathologies
  • suspicious to extra-uterus pregnancy
  • sign and symptoms of uterus infection
  • Molar pregnancy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 400 microgram misoprostol
400 micrograms misoprostol each 6 hours for 8 dose
Drug: Misoprostol 400 micrograms
Misoprostol 400 micrograms each 6 hours for 8 dose
Other Names:
  • Cytotec
Active Comparator: 800 micrograms misoprostol
800 micrograms misoprostol each 12 hours for 4 dose
Drug: Misoprostol 800 micrograms
Misoprostol 800 micrograms each 12 hours for 4 doses
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abortion
Time Frame: 48 hours after treatment
After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion.
48 hours after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of abortion
Time Frame: Form the begining of treatment to complete abortion
Duration of abortion Form the begining of treatment to complete abortion
Form the begining of treatment to complete abortion
Adverse Effects
Time Frame: 48 hours after treatment
including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash
48 hours after treatment
Need for surgery
Time Frame: 48 hours after treatment
Dilatation & cartage
48 hours after treatment

Collaborators and Investigators

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

Sponsor

Hormozgan University of Medical Sciences

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

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

September 30, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Misoprostol in termination

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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