Blood Loss, SurgicalPhase 3MORESTABLNCT06078501
MisOpRostol Effect on Second Trimester Abortion Blood Loss
A Phase 3 study testing Misoprostol 400mcg buccal in people with Blood Loss, Surgical and Second Trimester Abortion, run by Stanford University at 1 site in United States.
Trial summary
Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical, Second Trimester Abortion
- What is being tested?
- Misoprostol 400mcg buccal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 12 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; English or Spanish speaking, able to consent for a research study, literate in English or Spanish.
Who cannot join
- known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospital
Palo Alto, California, 94304
About this study
Official title: Misoprostol Effect on Second Trimester Abortion Blood Loss
Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described.
We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.
- Conditions
- Blood Loss, Surgical, Second Trimester Abortion
- Being tested
- Misoprostol 400mcg buccal, Placebo
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 400mcg buccalDrug
Also called cytotec
Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
PlaceboDrug
Placebo buccal administration 2-3 hours prior to procedure
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol 400mcg buccal | Experimental | Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure Receives: Drug: Misoprostol 400mcg buccal |
| Placebo | Placebo comparator | Participants will take a placebo buccally 2-3 hours prior to their procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss
Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.
Measured: day of procedure (approximately 1 hour)
Secondary outcomes (10)
Patient-reported Pain Scale Score
Pain rated on a scale of 0 (no pain) to 10 (worst pain imaginable).
Measured: Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure)
Overall Satisfaction With Care Experience Scale Score
Satisfaction rated on a scale of 0 (not satisfied) to 10 (most satisfied).
Measured: after procedure (approximately 1 minute to complete survey)
Number of Participants With Vaginal Bleeding
Vaginal bleeding is an anticipated part of the procedure and is not always considered to be an adverse event.
Measured: during procedure (up to 1 hour), after medication administration
Number of Participants With Abdominal Pain
Abdominal pain is an anticipated part of the procedure and is not always considered to be an adverse event.
Measured: during procedure (up to 1 hour), after medication administration
Procedure Time
Measured: up to 1 hour
Physician-rated Ease of Use Scale Score
Ease of use rated from 1 (easiest) to 10 (most difficult)
Measured: after procedure (approximately 1 minute to complete survey)
Number of Participants Estimated Blood Loss >500 ml
Estimated Blood Loss calculated by subjective visual estimate based on visible blood on instruments, drapes, and suction container contents.
Measured: during procedure (up to 1 hour)
Number of Participants Requiring Manual Dilation
Measured: during procedure (up to 1 hour)
Physician-rated Satisfaction With Dilation Scale Score
Satisfaction rated from 1 (least satisfied) to 10 (most satisfied)
Measured: after procedure (approximately 1 minute to complete survey)
Clinician Correctly Guessed Group to Which Participant Was Randomized
Measured: after procedure (approximately 1 minute to complete survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start8 Feb 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Why it stopped: Recruitment not feasible for this patient population within study timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078501
- Sponsor's protocol ID
- 72229
- Acronym
- MORESTABL
- Status last verified
- Aug 2025
- First submitted
- 5 Oct 2023
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Effect on Second Trimester Abortion Blood Loss
- ClinicalTrials.gov ID
- NCT06078501
- Acronym / sponsor ID
- MORESTABL / 72229
- Conditions
- Blood Loss, Surgical, Second Trimester Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment not feasible for this patient population within study timeframe
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described.
We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol 400mcg buccal | Experimental | Drug: Misoprostol 400mcg buccalParticipants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take a placebo buccally 2-3 hours prior to their procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; English or Spanish speaking, able to consent for a research study, literate in English or Spanish.
Key exclusion criteria (1 listed)
- known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol 400mcg buccalAlso: cytotecMisoprostol 400mcg buccal administration 2-3 hours prior to procedure | Drug | Misoprostol 400mcg buccal |
| PlaceboPlacebo buccal administration 2-3 hours prior to procedure | Drug | Placebo |
Primary outcome
Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss
Time frame: day of procedure (approximately 1 hour)
Quantified blood loss calculated using a combination of gravimetric and direct measurements of drapes, suction contents, and suction container.
10 secondary outcomes
Patient-reported Pain Scale Score
Time frame: Day of procedure: before medication administration (2-3 hours prior to procedure); and after medication administration (up to 1 hour following completion of procedure)
Overall Satisfaction With Care Experience Scale Score
Time frame: after procedure (approximately 1 minute to complete survey)
Number of Participants With Vaginal Bleeding
Time frame: during procedure (up to 1 hour), after medication administration
Number of Participants With Abdominal Pain
Time frame: during procedure (up to 1 hour), after medication administration
Procedure Time
Time frame: up to 1 hour
Physician-rated Ease of Use Scale Score
Time frame: after procedure (approximately 1 minute to complete survey)
Number of Participants Estimated Blood Loss >500 ml
Time frame: during procedure (up to 1 hour)
Number of Participants Requiring Manual Dilation
Time frame: during procedure (up to 1 hour)
Physician-rated Satisfaction With Dilation Scale Score
Time frame: after procedure (approximately 1 minute to complete survey)
Clinician Correctly Guessed Group to Which Participant Was Randomized
Time frame: after procedure (approximately 1 minute to complete survey)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Blood Loss, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol 400mcg buccal in people with Blood Loss, Surgical and Second Trimester Abortion, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hemorrhage Greater Than 500 mL as a Measure of Quantified Blood Loss (time frame: day of procedure (approximately 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.