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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents	Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics

ClinicalTrials.gov processed this record on September 26, 2016

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