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Misoprostol Effect on Second Trimester Abortion Blood Loss (MORE STABL)

Primary Purpose

Blood Loss, Surgical, Second Trimester Abortion

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Misoprostol 400mcg buccal
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Misoprostol 400mcg buccal

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

quantified blood loss
QBL

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT06078501
Brief Title
Misoprostol Effect on Second Trimester Abortion Blood Loss
Acronym
MORE STABL
Official Title
Misoprostol Effect on Second Trimester Abortion Blood Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2024 (Anticipated)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Second Trimester Abortion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol 400mcg buccal
Arm Type
Experimental
Arm Description
Participants will take 400mcg buccal misoprostol 2-3 hours prior to their procedure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take a placebo bucally 2-3 hours prior to their procedure
Intervention Type
Drug
Intervention Name(s)
Misoprostol 400mcg buccal
Other Intervention Name(s)
cytotec
Intervention Description
Misoprostol 400mcg buccal administration 2-3 hours prior to procedure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo buccal administration 2-3 hours prior to procedure
Primary Outcome Measure Information:
Title
quantified blood loss
Description
QBL
Time Frame
day of procedure (approximately 1 hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate A Shaw, MD MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Misoprostol Effect on Second Trimester Abortion Blood Loss

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