Misoprostol

Generic Name: Misoprostol

Brand Names: Arthrotec, Cytotec, Mifegymiso

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₃₈O_₅

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

Clinical Trials

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Phase 4

Terminated

Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Pregnancy

Interventions: Drug: Misoprostol

First Posted Date: 2016-05-19

Last Posted Date: 2022-10-13

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 34

Registration Number: NCT02777190

Locations: 🇺🇸
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States

Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Phase 4

Conditions: Pregnancy
Induction of Labor
Cervical Ripening

Interventions: Drug: Misoprostol
Device: Foley catheter

First Posted Date: 2016-05-05

Last Posted Date: 2016-05-12

Lead Sponsor: Consorci Sanitari de Terrassa

Target Recruit Count: 80

Registration Number: NCT02762942

Locations: 🇪🇸
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain

Failure of Vaginal Delivery After Induction

Phase 3

Completed

Conditions: Labor Pain

Interventions: Drug: Misoprostol
Device: foley's balloon catheter

First Posted Date: 2016-05-02

Last Posted Date: 2016-11-29

Lead Sponsor: Karachi Medical and Dental College

Target Recruit Count: 335

Registration Number: NCT02758340

Locations: 🇵🇰
Abbasi shaheed hospital, Karachi, Sindh, Pakistan

Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks

Phase 4

Conditions: Medical Abortion

Interventions: Drug: Mifepristone
Drug: Misoprostol

First Posted Date: 2016-04-20

Last Posted Date: 2016-06-20

Lead Sponsor: Ibis Reproductive Health

Target Recruit Count: 648

Registration Number: NCT02745093

Locations: 🇲🇽
Marie Stopes Mexico Azcapotzalco, Del. Azcapotzalco, Mexico Distrito Federal, Mexico
🇲🇽
Marie Stopes Mexico Pedregal, Del. Tlalpan, Mexico Distrito Federal, Mexico
🇲🇽
Marie Stopes Mexico Roma, Del. Cuauhtémoc, Mexico Distrito Federal, Mexico

Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

Phase 2

Conditions: Cervical Ripening

Interventions: Drug: misoprostol and Isosorbide-5-mononitrate
Drug: Isosorbide-5-mononitrate
Drug: Misoprostol

First Posted Date: 2016-04-14

Last Posted Date: 2016-04-14

Lead Sponsor: Cairo University

Target Recruit Count: 90

Registration Number: NCT02738177

Locations: 🇪🇬
Kasr Elainy Hospital (Cairo University), Cairo, Egypt

Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Not Applicable

Completed

Conditions: Incomplete Abortion

Interventions: Drug: Misoprostol

First Posted Date: 2016-03-14

Last Posted Date: 2018-06-12

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 75

Registration Number: NCT02707653

Locations: 🇲🇲
Thingyan Sanpya Hospital, Yangon, Myanmar
🇲🇲
Central Woman's Hospital, Yangon, Myanmar

Two Different Regimens of Misoprostol in Retained Placenta

Phase 2

Completed

Conditions: Retained Placenta
Postpartum Haemorrhage

Interventions: Drug: Misoprostol

First Posted Date: 2016-03-10

Last Posted Date: 2019-02-22

Lead Sponsor: Hawler Medical University

Target Recruit Count: 509

Registration Number: NCT02704780

Locations: 🇮🇶
Hawler Medical university, Erbil, Kurdistan Region, Iraq

Non-surgical Alternatives to Treatment of Failed Medical Abortion

Phase 4

Terminated

Conditions: Abortion Failure

Interventions: Drug: Misoprostol
Drug: Mifepristone
Drug: Placebo mifepristone
Drug: Placebo misoprostol

First Posted Date: 2016-03-10

Last Posted Date: 2021-07-26

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 16

Registration Number: NCT02704481

Locations: 🇺🇸
Planned Parenthood of Northern California, Concord, California, United States
🇺🇸
Presidential Women's Center, West Palm Beach, Florida, United States
🇺🇸
Family Planning Associates Medical Group, Ltd., Chicago, Illinois, United States

and more 11 locations