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Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

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ClinicalTrials.gov Identifier: NCT01508143
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Hamidreza Mahboobi, Hormozgan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Termination Drug: Misoprostol 400 micrograms Drug: Misoprostol 800 micrograms Not Applicable

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  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

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

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 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of abortion [ Time Frame: Form the begining of treatment to complete abortion ]
    Duration of abortion Form the begining of treatment to complete abortion

  2. Adverse Effects [ Time Frame: 48 hours after treatment ]
    including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash

  3. Need for surgery [ Time Frame: 48 hours after treatment ]
    Dilatation & cartage



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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: September 2012

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

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