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Misoprostol

Generic Name
Misoprostol
Brand Names
Arthrotec, Cytotec, Mifegymiso
Drug Type
Small Molecule
Chemical Formula
C22H38O5
CAS Number
59122-46-2
Unique Ingredient Identifier
0E43V0BB57
Background

Misoprostol is a prostaglandin analog used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for first trimester abortions. The stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and cervix can increase the strength and frequency of contractions and decrease cervical tone.

Misoprostol was granted FDA approval on 27 December 1988.

Indication

Misoprostol is indicated as a tablet to reduce the risk of NSAID induced gastric ulcers but not duodenal ulcers in high risk patients. Misoprostol is also formulated in combination with diclofenac to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers. Misoprostol is used off label for the management of miscarriages, prevention of post partum hemorrhage, and is also used alone or in combination with mifepristone in other countries for first trimester abortions.

Associated Conditions
Gastric Ulcer, Incomplete Abortion, Missed Abortion, Postpartum Haemorrhage (PPH)
Associated Therapies
Induction of cervix ripening therapy, Medically induced abortion

Misoprostol in Termination of First Trimester Missed Abortion

Not Applicable
Completed
Conditions
Miscarriage
Interventions
First Posted Date
2008-11-25
Last Posted Date
2008-11-25
Lead Sponsor
Hawler Medical University
Target Recruit Count
100
Registration Number
NCT00797693
Locations
🇮🇶

Maternity Teaching Hospital, Erbil, Hawler, Iraq

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Not Applicable
Completed
Conditions
Abortion, Induced
Interventions
Drug: mifepristone+misoprostol
Drug: placebo
First Posted Date
2008-11-02
Last Posted Date
2014-02-20
Lead Sponsor
Gynuity Health Projects
Target Recruit Count
120
Registration Number
NCT00784186
Locations
🇻🇳

National Ob-Gyn Hospital, Hanoi, Vietnam

🇻🇳

Hung Vuong Hospital, Ho Chi Minh City, Vietnam

Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

Phase 4
Conditions
Labor
Interventions
First Posted Date
2008-06-11
Last Posted Date
2008-07-10
Lead Sponsor
China Medical University Hospital
Target Recruit Count
143
Registration Number
NCT00695331
Locations
🇨🇳

Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital, Taichung, Taiwan

Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone

Not Applicable
Completed
Conditions
Pregnancy Termination
Interventions
First Posted Date
2008-05-20
Last Posted Date
2013-03-13
Lead Sponsor
Gynuity Health Projects
Target Recruit Count
440
Registration Number
NCT00680394
Locations
🇹🇳

La Rabta Hospital, Tunis, Tunisia

🇻🇳

Hung Vuong Hospital, Ho Chi Minh City, Vietnam

Medical Abortion for Emergency Contraception Failure

Not Applicable
Completed
Conditions
Emergency Contraception
Abortion, Induced
Interventions
First Posted Date
2008-05-14
Last Posted Date
2008-05-16
Lead Sponsor
Taizhou Hospital
Target Recruit Count
394
Registration Number
NCT00677755
Locations
🇨🇳

Taizhou Hospital of zhejiang Province, Taizhou City, Zhejiang, China

Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

Not Applicable
Completed
Conditions
Incomplete Abortion
Interventions
Procedure: Surgical treatment
First Posted Date
2008-05-07
Last Posted Date
2008-05-07
Lead Sponsor
Gynuity Health Projects
Target Recruit Count
311
Registration Number
NCT00674232
Locations
🇪🇨

Hospital Gineco-obstetrico Isidro Ayora, Quito, Ecuador

🇪🇨

Hospital del Dia, CEMOPLAF, Quito, Ecuador

🇻🇪

Hospital Maternidad Concepcion Palacios, Caracas, Venezuela

Misoprostol for the Treatment of Incomplete Abortion

Not Applicable
Completed
Conditions
Abortion, Incomplete
Interventions
Procedure: MVA
First Posted Date
2008-05-02
Last Posted Date
2016-07-27
Lead Sponsor
Gynuity Health Projects
Target Recruit Count
720
Registration Number
NCT00670761
Locations
🇹🇿

Kagera Regional Hospital, Bukoba, Tanzania

🇧🇫

Hôpital de District Sanitaire Dandé, Bobo Dioulasso, Burkina Faso

🇲🇬

Befelatanana Maternity Centre, Antananarivo, Madagascar

and more 3 locations

Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

Phase 3
Completed
Conditions
Intrauterine Fetal Demise
Interventions
First Posted Date
2008-05-02
Last Posted Date
2013-05-08
Lead Sponsor
Gynuity Health Projects
Target Recruit Count
153
Registration Number
NCT00671060
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

🇺🇸

Christiana Care Health System, Newark, Delaware, United States

🇻🇳

Huong Vuong Hospital, Ho Chi Minh City, Vietnam

and more 2 locations

Misoprostol With Intrauterine Device Insertion

Not Applicable
Completed
Conditions
Contraception
Interventions
Dietary Supplement: Magnesium Oxide
First Posted Date
2008-02-13
Last Posted Date
2013-03-15
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
40
Registration Number
NCT00613366
Locations
🇺🇸

Planned Parenthood of the Columbia Willamette, Portland, Oregon, United States

🇺🇸

Oregon Health & Science University, Portland, Oregon, United States

Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

Phase 3
Completed
Conditions
Pregnancy
Interventions
Device: Bard Catheter (balloon catheter)
First Posted Date
2008-01-28
Last Posted Date
2008-01-28
Lead Sponsor
Karolinska University Hospital
Target Recruit Count
592
Registration Number
NCT00602095
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