NCT00835731

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 7, 2014

Completed
Last Updated

October 23, 2017

Status Verified

September 1, 2017

Enrollment Period

2.9 years

First QC Date

February 3, 2009

Results QC Date

June 13, 2013

Last Update Submit

September 20, 2017

Conditions

Cervical Ripening

Keywords

induced abortionmisoprostolcervical ripeningsecond trimester abortionDilapan-S

Outcome Measures

Primary Outcomes (1)

  • Cervical Dilation in Women Following Exposure to Either Ripening Agent

    3-4 hours after placement of ripening agent

Secondary Outcomes (6)

  • Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report

    3-4 hours after placement of ripening agent

  • Procedure Time for Dilation and Evacuation

    3-4 hours after placement of ripening agent

  • Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt

    3-4 hours after placement of ripening agent

  • Subject Pain During Ripening

    3-4 hours after placement of ripening agent

  • Subject Pain During Dilation and Evacuation

    3-4 hours after placement of ripening agent

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

400mcg buccal misoprostol

Drug: misoprostol

2

EXPERIMENTAL

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

Device: Dilapan-S, vitamin B-12

Interventions

misoprostolDRUG

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

Also known as: Cytotec
1
Dilapan-S, vitamin B-12DEVICE

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

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 34061352DERIVED

  • 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.

    PMID: 23743471DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Principal Investigator
Organization
Planned Parenthood League of Massachusetts
6176161600

Study Officials

  • Prinicpal Investigator

    Planned Parenthood League of Massachusetts

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 23, 2017

Results First Posted

January 7, 2014

Record last verified: 2017-09

Locations

US(1)