MisOpRostol Effect on Second Trimester Abortion Blood Loss

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-07-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Loss, Surgical Second Trimester Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Misoprostol 400mcg buccal

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

Group Type EXPERIMENTAL

Misoprostol 400mcg buccal

Intervention Type DRUG

Misoprostol 400mcg buccal administration 2-3 hours prior to procedure

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo buccal administration 2-3 hours prior to procedure

Interventions

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Misoprostol 400mcg buccal

Misoprostol 400mcg buccal administration 2-3 hours prior to procedure

Intervention Type DRUG

Placebo

Placebo buccal administration 2-3 hours prior to procedure

Intervention Type DRUG

Other Intervention Names

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cytotec

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No