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MORE STABL: Misoprostol Effect on Second Trimester Abortion Blood Loss

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06078501
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Misoprostol 400mcg buccal
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Misoprostol Effect on Second Trimester Abortion Blood Loss
Anticipated Study Start Date :
Jan 15, 2024
Anticipated Primary Completion Date :
Apr 15, 2025
Anticipated Study Completion Date :
Apr 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Misoprostol 400mcg buccal

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

Drug: Misoprostol 400mcg buccal
Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
Other Names:
  • cytotec

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Placebo buccal administration 2-3 hours prior to procedure

    Outcome Measures

    Primary Outcome Measures

    1. quantified blood loss [day of procedure (approximately 1 hour)]

      QBL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Hospital Palo Alto California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Kate A Shaw, MD MS, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kate Ayers Shaw, Associate Professor in Obstetrics and Gynecology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT06078501
    Other Study ID Numbers:
    • 72229
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Hemorrhage
    Blood Loss, Surgical
    Misoprostol

    Study Results

    No Results Posted as of Oct 12, 2023