Misoprostol

NSAID use, prophylaxis of Gastric ulcer, Postpartum Hemorrhage + 8 more
Treatment
5 FDA approvals
11 Active Studies for Misoprostol

What is Misoprostol

MisoprostolThe Generic name of this drug
Treatment SummaryMisoprostol is a drug that works by activating prostaglandin receptors in the stomach and uterus. It is used to reduce the risk of ulcers caused by non-steroidal anti-inflammatory drugs, to manage miscarriages, to prevent postpartum bleeding, and for first trimester abortions. Misoprostol was approved by the FDA in 1988.
Cytotecis the brand name
image of different drug pills on a surface
Misoprostol Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Cytotec
Misoprostol
1986
109

Approved as Treatment by the FDA

Misoprostol, also known as Cytotec, is approved by the FDA for 5 uses which include Gastric Ulcer and Stomach Ulcer .
Gastric Ulcer
Stomach Ulcer
Medically induced abortion
Used to treat Medically induced abortion in combination with Mifepristone
NSAID use
prophylaxis of Gastric ulcer

Effectiveness

How Misoprostol Affects PatientsMisoprostol is a drug that is used to reduce the risk of stomach ulcers caused by taking NSAIDs. It can also be used to treat miscarriages or abortions. Depending on how it is taken, the drug starts working between 8-100 minutes and lasts for about 2-4 hours.
How Misoprostol works in the bodyMisoprostol is a drug similar to prostaglandin that works to reduce the amount of acid in the stomach and increase protective secretions like mucus. It also acts on the lining of the uterus to increase contractions, loosen the cervix, and break down collagen.

When to interrupt dosage

The amount of Misoprostol is contingent upon the diagnosed condition, including Incomplete Abortion, prophylaxis of Gastric ulcer and Missed Abortion. The dose may differ, in line with the procedure of administration (e.g. Tablet - Oral or Oral) featured in the table underneath.
Condition
Dosage
Administration
Postpartum Hemorrhage
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
prophylaxis of Gastric ulcer
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Abortion, Incomplete
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Labour
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Postpartum Hemorrhage
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
NSAID use
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Cervix Uteri
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Stomach Ulcer
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Medically induced abortion
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Induction of Labour
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet
Abortion, Spontaneous
0.2 mg, , 0.1 mg
Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Warnings

Misoprostol has one contraindication. It should not be employed when dealing with the conditions detailed in the following table.Misoprostol Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
There are 2 known major drug interactions with Misoprostol.
Common Misoprostol Drug Interactions
Drug Name
Risk Level
Description
Carbetocin
Major
The risk or severity of adverse effects can be increased when Misoprostol is combined with Carbetocin.
Oxytocin
Major
The risk or severity of adverse effects can be increased when Misoprostol is combined with Oxytocin.
Misoprostol Toxicity & Overdose RiskThe lowest toxic dose of misoprostol in rats has been found to be 81mg/kg and 27mg/kg in mice. Signs of an overdose may include drowsiness, trembling, seizures, difficulty breathing, abdominal pain, diarrhea, fever, heart palpitations, low blood pressure, and slow heart rate. Hemodialysis is not likely to help in overdosing on misoprostol but activated charcoal may help reduce absorption. Treatment for an overdose may include removing any undissolved tablets from the mouth or vagina, giving intravenous fluids, taking acetaminophen, diazepam, haloperidol,
image of a doctor in a lab doing drug, clinical research

Misoprostol Novel Uses: Which Conditions Have a Clinical Trial Featuring Misoprostol?

Three ongoing studies are investigating Misoprostol's potential for Medically induced abortion, Gastric ulcer prophylaxis and NSAID use.
Condition
Clinical Trials
Trial Phases
Induction of Labour
1 Actively Recruiting
Phase 4
Cervix Uteri
0 Actively Recruiting
Postpartum Hemorrhage
0 Actively Recruiting
Abortion, Incomplete
0 Actively Recruiting
prophylaxis of Gastric ulcer
0 Actively Recruiting
Labour
2 Actively Recruiting
Phase 4, Phase 3
Medically induced abortion
0 Actively Recruiting
Abortion, Spontaneous
0 Actively Recruiting
Stomach Ulcer
2 Actively Recruiting
Phase 4, Not Applicable
Postpartum Hemorrhage
5 Actively Recruiting
Phase 2, Not Applicable
NSAID use
0 Actively Recruiting

Misoprostol Reviews: What are patients saying about Misoprostol?

5Patient Review
10/23/2022
Misoprostol for Abortion
After taking the first set of pills, I took four more 24 hours later. Almost immediately, I started feeling intense cramping which was only alleviated somewhat by sitting on the toilet. In addition to this, I passed large clots and experienced heavy bleeding. Despite all of this, I can say that the pain is manageable now and the bleeding has slowed down significantly.
5Patient Review
11/12/2022
Misoprostol for Abortion
Though I can't speak for everyone, this treatment wasn't as bad as some of the reviews made it out to be. For me, there was constant cramping, but heating pad and baths helped a lot. I was even able to eat during the treatment!
5Patient Review
10/31/2022
Misoprostol for Abortion
I took the medication as directed and experienced mild cramping around 1pm. I began bleeding shortly thereafter and passed a number of clots. Overall, it wasn't as bad as I had anticipated based on other reviews I had read.
3.7Patient Review
11/13/2022
Misoprostol for Abortion
The effects were great for the first few hours, then I started to feel really bad. I was in a lot of pain and crying for many hours into the next day.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about misoprostol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Clinical Trials for Misoprostol

Image of Sentara Norfolk General Hospital in Norfolk, United States.

Lactated Ringer's + Dextrose for Induction of Labour

18+
Female
Norfolk, VA
The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are: 1. Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers? 2. Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.
Phase 4
Recruiting
Sentara Norfolk General Hospital
Image of Brigham and Women's Hospital in Boston, United States.

Low Thermal Plasma for Marginal Ulcers

18+
All Sexes
Boston, MA
The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.
Recruiting
Has No Placebo
Brigham and Women's HospitalChristopher C. Thompson, MD, MSc
Image of Vanderbilt University Medical Center in Nashville, United States.

Risk Prediction Model for Postpartum Hemorrhage

Any Age
Female
Nashville, TN
This research project aims to enhance the safety of childbirth by using advanced computer models to predict the risk of postpartum hemorrhage (PPH). PPH is a significant concern for mothers during and after delivery. Current risk assessment tools are basic and do not adapt to changing conditions. This study will investigate whether a new and recently validated model for predicting PPH, combined with a provider-facing Best Practice Advisory (BPA) regarding currently recommended strategies triggered by an increased predicted risk, can improve perinatal outcomes. This study will compare the current category based risk assessment tool with a new, enhanced prediction model which calculates risk based on 21 factors, automatically updates as new information becomes available during labor and, if elevated, provides a provider-facing Best Practice Advisory (BPA) recommending consideration of strategies that are institutionally agreed to represent high-quality practice. Investigators hypothesize that the enhanced care approach will result in improved perinatal outcomes. The goal of the study is to improve the wellbeing of mothers during childbirth by harnessing the power of modern technology and data analysis.
Recruiting
Has No Placebo
Vanderbilt University Medical CenterHolly Ende, MD
Have you considered Misoprostol clinical trials? We made a collection of clinical trials featuring Misoprostol, we think they might fit your search criteria.Go to Trials
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Carbetocin vs Oxytocin for Postpartum Hemorrhage

18 - 50
Female
Toronto, Canada
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH. This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa. The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.
Recruiting
Has No Placebo
Mount Sinai HospitalMrinalini Balki, MD
Image of Icahn School of Medicine at Mount SInai in New York, United States.

Ephedrine for Childbirth

18 - 55
Female
New York, NY
Labor analgesia is an important component of the care of laboring patients. A known side effect of combined spinal and epidural anesthesia (a type of labor analgesia) is an increased incidence of category II fetal heart rate tracing (defined below) and low blood pressure. The study team aims to study if a prophylactic dose of ephedrine will decrease the occurrence of this type of tracing after combined spinal epidural (CSE) anesthesia placement. Ephedrine is not currently routinely used as prevention for category II tracings or low blood pressure. The use of Ephedrine in this study is investigational (this is the first time that the drug has been studied for its effect on these conditions). Fetal heart rate (FHR) tracings are classified into three categories. In clinical practice, FHR tracing categories are used as a guide to obstetric management and suggest the following approach: * Category I tracing is "reactive" and reassuring → may continue labor * Category II tracing is neither category I nor category III. For obvious reasons, category II is the broadest and largest category, consisting of various FHR tracing patterns that do not fit into either category I or category III. * Category III tracing is non-reassuring → expedited vaginal or cesarean delivery recommended. A Category II tracing is not diagnostic. Most pregnancies have at least one Category II tracing. There is not always an identifiable reason for a Category II tracing. Ephedrine is a medication that causes an increase in heart rate and blood pressure while also causing some degree of relaxation of the uterus therefore improving uterine blood flow. It has been used in the obstetric population for over 50 years without issues. The dose that the research team will administer, 7.5 mg, is below the dose the research team will often administer to treat hypotension (low blood pressure).
Phase 4
Recruiting
Icahn School of Medicine at Mount SInai (+1 Sites)James Leader
Have you considered Misoprostol clinical trials? We made a collection of clinical trials featuring Misoprostol, we think they might fit your search criteria.Go to Trials
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Tranexamic Acid for Postpartum Hemorrhage

18 - 50
Female
Washington, United States
In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section. The investigators administered three doses of the drug (5 mg/kg, 10 mg/kg and 15 mg/kg) in an escalating fashion by cohort with the lowest dose first. The drug was administered intravenously at the time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 gram was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 microg/mL. A PK model was constructed for determining the optimal TXA dose administered at parturition. In part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1000 mg TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus \< 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery greater than 34 weeks gestation, women undergoing vaginal delivery \> 34 weeks of gestation and morbidly obese women (BMI\>=40) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigatorsalso aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \> 50) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.
Phase 2
Recruiting
George Washington University Hospital (+4 Sites)Homa K Ahmadzia, MD
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