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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

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE January 11, 2012
Last Update Posted Date October 2, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
  • Duration of abortion [ Time Frame: Form the begining of treatment to complete abortion ]
    Duration of 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
  • Need for surgery [ Time Frame: 48 hours after treatment ]
    Dilatation & cartage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination
Official Title  ICMJE A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009
Brief Summary The aim of this study is to compare two misoprostol regimen in pregnancy termination.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Termination
Intervention  ICMJE
  • Drug: Misoprostol 400 micrograms
    Misoprostol 400 micrograms each 6 hours for 8 dose
    Other Name: Cytotec
  • Drug: Misoprostol 800 micrograms
    Misoprostol 800 micrograms each 12 hours for 4 doses
    Other Name: Cytotec
Study Arms  ICMJE
  • Experimental: 400 microgram misoprostol
    400 micrograms misoprostol each 6 hours for 8 dose
    Intervention: Drug: Misoprostol 400 micrograms
  • Active Comparator: 800 micrograms misoprostol
    800 micrograms misoprostol each 12 hours for 4 dose
    Intervention: Drug: Misoprostol 800 micrograms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2012)
41
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508143
Other Study ID Numbers  ICMJE Misoprostol in termination
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamidreza Mahboobi, Hormozgan University of Medical Sciences
Study Sponsor  ICMJE Hormozgan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hormozgan University of Medical Sciences
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP