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

Arm | Intervention/treatment |
---|---|
Experimental: 400 microgram misoprostol
400 micrograms misoprostol each 6 hours for 8 dose
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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
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Drug: Misoprostol 800 micrograms
Misoprostol 800 micrograms each 12 hours for 4 doses
Other Name: Cytotec |
- 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.
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Iran, Islamic Republic of | |
Hormozgan University of Medical Sciences | |
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388 |
Responsible Party: | Hamidreza Mahboobi, Medical Doctor, Hormozgan University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01508143 |
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 |
Abortion Pregnancy Termination Misoprostol |
Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |