Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01508143

First Posted: January 11, 2012

Last Update Posted: October 2, 2012

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Information provided by (Responsible Party):

Hamidreza Mahboobi, Hormozgan University of Medical Sciences

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 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

Resource links provided by NLM:

Drug Information available for: Misoprostol

U.S. FDA Resources

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

Primary Outcome Measures:

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:

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


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

Information from the National Library of Medicine

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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

Contacts and Locations

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

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
First Submitted:	January 9, 2012
First Posted:	January 11, 2012
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

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