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Misoprostol Versus Dilapan-S for Cervical Preparation

NCT ID: NCT00835731

Last Updated: 2017-10-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.

Detailed Description

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Conditions

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Cervical Ripening

Keywords

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induced abortion misoprostol cervical ripening second trimester abortion Dilapan-S

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

400mcg buccal misoprostol

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E

2

Dilapan-S, control: vitamin B-12 administered sublingually

Group Type EXPERIMENTAL

Dilapan-S, vitamin B-12

Intervention Type DEVICE

One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E

Interventions

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misoprostol

400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E

Intervention Type DRUG

Dilapan-S, vitamin B-12

One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E

Intervention Type DEVICE

Other Intervention Names

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Cytotec

Eligibility Criteria

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Inclusion Criteria

* medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
* gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
* proficient in English or Spanish
* agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction

Exclusion Criteria

* less than 18 years old
* cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
* inflammatory bowel disease
* contraindication to misoprostol use
* known intolerance or allergy to misoprostol or Dilapan-S
* inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Planned Parenthood League of Massachusetts

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prinicpal Investigator

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood League of Massachusetts

Locations

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Planned Parenthood League of Massachusetts

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.

Reference Type DERIVED
PMID: 34061352 (View on PubMed)

Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.

Reference Type DERIVED
PMID: 23743471 (View on PubMed)

Other Identifiers

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SFP2-3

Identifier Type: -

Identifier Source: org_study_id