Misoprostol for Second Trimester Abortion Blood Loss

(MORESTABL Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Disqualifiers: Coagulopathy, Morbidly adherent placenta, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a medication called misoprostol can reduce blood loss during second-trimester abortions. Doctors already use misoprostol to prepare the cervix before the procedure, and it is known to decrease blood loss in other situations. However, its effect on blood loss during this specific procedure remains unclear. The study involves two groups: one taking misoprostol and the other a placebo (a pill with no active medicine) before the procedure. The trial seeks pregnant individuals between 18 and 23 weeks who plan a procedural abortion and can understand English or Spanish. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that misoprostol often prepares the cervix before abortion procedures. It also reduces blood loss in first trimester abortions and treats heavy bleeding after childbirth. One study found that using misoprostol in the second trimester is generally safe, though risks exist, such as the possibility of uterine tearing or the need for additional surgery or a blood transfusion.

Previous use of misoprostol in pregnant women has indicated potential risks, including early birth and, in rare cases, birth defects. However, it is usually well-tolerated when used correctly.

Given the current trial phase, some evidence already supports its safety in humans. Ongoing research aims to better understand its effects on blood loss in second trimester abortions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using misoprostol for reducing blood loss during second trimester abortions because it offers a non-surgical approach to managing this issue. Misoprostol is unique in that it can be administered buccally, meaning it's placed in the cheek to dissolve, which is more convenient and less invasive than some other methods. Unlike traditional treatments that may involve surgical interventions, misoprostol works by causing the uterus to contract, thereby helping to control bleeding. This approach not only simplifies the procedure but also potentially enhances safety and comfort for patients.

What evidence suggests that misoprostol might be an effective treatment for reducing blood loss during second trimester abortion?

In this trial, participants will receive either misoprostol or a placebo to evaluate its effectiveness in reducing blood loss during second trimester abortions. Research has shown that misoprostol can help reduce blood loss during these procedures. This medication often prepares the cervix before the procedure and helps control bleeding. Studies have found that misoprostol effectively reduces blood loss in first trimester abortions and treats heavy bleeding after childbirth. In second trimester procedures, only a small number of cases experienced significant blood loss when misoprostol was used. Overall, misoprostol appears promising in managing bleeding during these procedures. ^{2 6 7 8 9}

Who Is on the Research Team?

Kate A Shaw, MD MS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals, 18 or older, who are between 18 to nearly 24 weeks into their pregnancy and have decided on an induced abortion. They must be able to understand and consent in English or Spanish. People with blood clotting disorders, suspected placenta complications, multiple pregnancies, current infections, ruptured membranes, or fetal demise at enrollment cannot participate.

Inclusion Criteria

I am pregnant, over 18, planning an induced abortion, and speak English or Spanish.

Exclusion Criteria

Suspected morbidly adherent placenta spectrum

Ruptured membranes

I have a blood clotting disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 400mcg buccal misoprostol or placebo 2-3 hours prior to the procedural abortion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of symptoms and experiences

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Misoprostol
• Placebo

Trial Overview The study tests if Misoprostol (a drug used for cervical preparation) given before a second trimester abortion can reduce blood loss compared to a placebo. Participants will either receive the Misoprostol or a placebo without knowing which one they get. The main focus is measuring the amount of blood lost during the procedure.

How Is the Trial Designed?

Group I: Misoprostol 400mcg buccal Experimental Treatment 1 Intervention

Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure

Group II: Placebo Placebo Group 1 Intervention

Participants will take a placebo buccally 2-3 hours prior to their procedure

Misoprostol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cytotec for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in European Union as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Approved in Canada as Misoprostol for:

• Abortion
• Cervical Ripening
• Gynecological Conditions
• Duodenal Ulcer
• NSAID-Induced Ulcer Prophylaxis
• Stomach Ulcer
• Labor Induction
• Postpartum Bleeding

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/01/NCT06078501/Prot_000.pdf

Misoprostol Effect on Second Trimester Abortion Blood Loss Misoprostol Effect on Second Trimester. Abortion Blood Loss. Study Protocol ... research study data. RedCap is designed with build-in features to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11015687/

Comparing the outcomes of termination of second trimester ... Intravaginal misoprostol is highly effective for termination of second trimester pregnancy with a live fetus, with a comparable success rate.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06078501

MisOpRostol Effect on Second Trimester Abortion Blood Loss An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7231932/

Misoprostol complications in second-trimester termination ... The results also showed that 4.57% of the subjects of the study lost more than 500 mL of blood during the pregnancy termination and 3.4% of ...

5. ajog.org ajog.org/article/S0002-9378(24)00930-X/fulltext

Efficacy of pharmacologic hemorrhage prophylactics in ... This study aimed to evaluate prophylactic uterotonics, antifibrinolytic medications, and vasoconstrictive agents in the prevention of hemorrhage during second- ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539873/

Misoprostol - StatPearls - NCBI Bookshelf - NIH Misoprostol use in pregnant women has been associated with premature birth, congenital abnormalities, and abortion. A risk of uterine rupture ...

7. ajog.org ajog.org/article/S0002-9378(04)01345-6/fulltext

Safety and efficacy of misoprostol for second-trimester ... Primary safety outcomes include uterine rupture, maternal death, need for laparotomy, or blood transfusion. Primary efficacy outcomes include time to delivery ...

8. societyfp.org societyfp.org/wp-content/uploads/2023/11/SFP_Clinical-Recommendation_Medication-abortion-between-14-0.7-and-27-6.7-weeks-of-gestation_2023_Final.pdf

SFP_Clinical-Recommendation_Medication-abortion- ... The objective of this Clinical Recommendation is to review relevant literature and provide evidence-based re- commendations for medication abortion between ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782423001609

Maternal complications associated with second trimester ... Second trimester medical abortion with mifepristone and misoprostol is generally safe, however, on occasions serious complications may occur.