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Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamidreza Mahboobi, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01508143
First received: January 9, 2012
Last updated: September 30, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Termination
 Drug: Misoprostol 400 micrograms
Drug: Misoprostol 800 micrograms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009

Resource links provided by NLM:

Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • Abortion [ Time Frame: 48 hours after treatment ] [ Designated as safety issue: No ]
    After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion.


Secondary Outcome Measures:
  • Duration of abortion [ Time Frame: Form the begining of treatment to complete abortion ] [ Designated as safety issue: No ]
    Duration of abortion Form the begining of treatment to complete abortion

  • Adverse Effects [ Time Frame: 48 hours after treatment ] [ Designated as safety issue: Yes ]
    including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash

  • Need for surgery [ Time Frame: 48 hours after treatment ] [ Designated as safety issue: No ]
    Dilatation & cartage


Enrollment: 41
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cytotec

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508143

Locations
Iran, Islamic Republic of
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Hamidreza Mahboobi, Medical Doctor, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01508143     History of Changes
Other Study ID Numbers: Misoprostol in termination
Study First Received: January 9, 2012
Last Updated: September 30, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Abortion
Pregnancy
Termination
Misoprostol

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 19, 2013