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

Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Not Applicable

Conditions: Transient Tachypnea Newborn
Cesarean Delivery Affecting Fetus

Interventions: Drug: Placebos
Drug: Misoprostol

First Posted Date: 2017-01-25

Last Posted Date: 2018-05-29

Lead Sponsor: Ain Shams University

Target Recruit Count: 170

Registration Number: NCT03031353

Locations: 🇪🇬
Faculty of Medicine, Ain Shams University, Cairo, Al Qahirah, Egypt

Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy

Phase 2

Completed

Conditions: Late Second Trimester Termination of Pregnancy

Interventions: Drug: MisoprostoL
Device: Foley Catheter

First Posted Date: 2016-12-12

Last Posted Date: 2018-02-07

Lead Sponsor: Zagazig University

Target Recruit Count: 97

Registration Number: NCT02989324

Locations: 🇪🇬
Zagazig University, Zagazig, Egypt

Acceptability and Feasibility of Medical Abortion in Singapore

Phase 3

Completed

Conditions: Medical Abortion

Interventions: Drug: Mifepristone
Drug: Misoprostol

First Posted Date: 2016-12-07

Last Posted Date: 2018-04-06

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 130

Registration Number: NCT02985229

Locations: 🇸🇬
KK Women's and Children's Hospital, Singapore, Singapore
🇸🇬
National University Hospital, Singapore, Singapore

Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine

Phase 4

Completed

Conditions: Abortion, Therapeutic

Interventions: Drug: Mifepristone
Drug: Misoprostol

First Posted Date: 2016-12-02

Last Posted Date: 2018-06-18

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 102

Registration Number: NCT02981030

Locations: 🇺🇦
Vinnitsa Regional Clinical Hospital, Vinnitsa, Ukraine
🇺🇦
Lviv Municipal Women's Consultation No. 2, L'viv, Ukraine

Vaginal Misoprostol and Foley Catheter for Induction of Labor

Phase 2

Completed

Conditions: Induction of Labor Affected Fetus / Newborn

Interventions: Drug: Misoprostol
Device: Foley Catheter

First Posted Date: 2016-11-02

Last Posted Date: 2017-06-16

Lead Sponsor: Zagazig University

Target Recruit Count: 160

Registration Number: NCT02952807

Locations: 🇪🇬
Zagazig University, Zagazig, Egypt

Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour

Phase 4

Conditions: Induced Deliveries

Interventions: Drug: Misoprostol

First Posted Date: 2016-09-28

Last Posted Date: 2016-09-28

Lead Sponsor: Karolinska Institutet

Target Recruit Count: 320

Registration Number: NCT02918110

Locations: 🇸🇪
Eva Wiberg-Itzel, Stockholm, Sweden

Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

Phase 4

Conditions: Postpartum Hemorrhage

First Posted Date: 2016-08-03

Last Posted Date: 2016-08-03

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 4330

Registration Number: NCT02853552

Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

Phase 4

Completed

Conditions: Postpartum Hemorrhage

Interventions: Drug: Tranexamic Acid
Drug: Placebo
Drug: Misoprostol

First Posted Date: 2016-06-20

Last Posted Date: 2018-02-19

Lead Sponsor: Gynuity Health Projects

Target Recruit Count: 260

Registration Number: NCT02805426

Locations: 🇻🇳
Hung Vuong Hospital, Ho Chi Minh City, Vietnam
🇸🇳
Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène, Thiès, Senegal
🇻🇳
National OB-GYN Hospital, Hanoi, Vietnam

and more 1 locations