NCT00310921

Brief Summary

The purpose of this study is to determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2001

Longer than P75 for phase_2

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

May 1, 2001

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 11, 2007

Status Verified

November 1, 2005

First QC Date

April 3, 2006

Last Update Submit

April 10, 2007

Conditions

Abortion, Therapeutic

Outcome Measures

Primary Outcomes (1)

  • The first assessment will be a Visual Box Scale (VBS) for pain administered while the patient is undergoing the abortion procedure.

Secondary Outcomes (1)

  • After the procedure the physician will estimate the patient's pain using a VBS. The physician will also estimate the ease of the procedure using a different VBS.

Interventions

MisoprostolDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Subject must not have a physical or mental health condition which could be adversely affected by the study drug, including a history of allergy to prostaglandins or, specifically, to misoprostol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente, Department of OB/GYN

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Seth Feigenbaum, M.D.

    Kaiser Permanente Medical Group, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

May 1, 2001

Study Completion

May 1, 2006

Last Updated

April 11, 2007

Record last verified: 2005-11

Locations

US(1)