Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

NCT ID: NCT02412618

Last Updated: 2022-03-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-01-31

Brief Summary

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A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Detailed Description

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Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D\&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.

Conditions

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Induced Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Mifepristone

Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once

Group Type ACTIVE_COMPARATOR

Mifepristone

Intervention Type DRUG

Progesterone antagonist

Misoprostol

Intervention Type DRUG

Prostaglandin E1

Placebo

Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

Prostaglandin E1

Placebo

Intervention Type DIETARY_SUPPLEMENT

Tasteless, odorless, sugar based pill

Interventions

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Mifepristone

Progesterone antagonist

Intervention Type DRUG

Misoprostol

Prostaglandin E1

Intervention Type DRUG

Placebo

Tasteless, odorless, sugar based pill

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Mifeprex Cytotec

Eligibility Criteria

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Inclusion Criteria

* healthy women
* eligible for non---urgent D\&E
* 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

Exclusion Criteria

* emergent need for D\&E
* fetal demise
* intolerance
* allergy or contraindication to mifepristone or misoprostol
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Casey FE, Ye PP, Perritt JD, Moreno-Ruiz NL, Reeves MF. A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Contraception. 2016 Aug;94(2):127-33. doi: 10.1016/j.contraception.2016.02.032. Epub 2016 Mar 4.

Reference Type DERIVED
PMID: 26948184 (View on PubMed)

Other Identifiers

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2012-245

Identifier Type: -

Identifier Source: org_study_id

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