Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

NCT ID: NCT01615731

Last Updated: 2024-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-07-31

Brief Summary

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A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

Detailed Description

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Conditions

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Abortion, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Two sets of dilators

Two sets of osmotic dilators inserted 1 and 2 days pre-op

Group Type ACTIVE_COMPARATOR

Hygroscopic cervical dilators

Intervention Type OTHER

Dilapan-S osmostic cervical dilators inserted through the internal os

Misoprostol

Intervention Type DRUG

400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin

Intervention Type DRUG

1mg digoxin administered intra-amniotically \~24 hours pre-op

Mifepristone plus one set of dilators

One set of dilators plus mifepristone

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

200mg Mifepristone orally

Hygroscopic cervical dilators

Intervention Type OTHER

Dilapan-S osmostic cervical dilators inserted through the internal os

Misoprostol

Intervention Type DRUG

400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin

Intervention Type DRUG

1mg digoxin administered intra-amniotically \~24 hours pre-op

Interventions

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Mifepristone

200mg Mifepristone orally

Intervention Type DRUG

Hygroscopic cervical dilators

Dilapan-S osmostic cervical dilators inserted through the internal os

Intervention Type OTHER

Misoprostol

400mcg buccal misoprostol 90 minutes pre-op

Intervention Type DRUG

Intra-amniotic digoxin

1mg digoxin administered intra-amniotically \~24 hours pre-op

Intervention Type DRUG

Other Intervention Names

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Danco, Mifeprex Dilapan-S

Eligibility Criteria

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Inclusion Criteria

* \>18 years old
* Viable, Singleton pregnancy
* Voluntarily seeking abortion between 19 and 24wks gestation
* Able to give informed consent and comply with study protocol
* Fluent in English or Spanish

Exclusion Criteria

* Allergy to misoprostol or mifepristone
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Santa Clara Valley Medical Center

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santa Clara Valley Medical Center

San Jose, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SU-05302012-10088

Identifier Type: -

Identifier Source: org_study_id

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