NCT00426491

Brief Summary

The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
Last Updated

February 8, 2008

Status Verified

February 1, 2008

Enrollment Period

7.6 years

First QC Date

January 22, 2007

Last Update Submit

February 1, 2008

Conditions

Abortifacient Agents, NonsteroidalAbortion, IncompleteMisoprostolPregnancy

Outcome Measures

Primary Outcomes (6)

  • time to resolution

    24hrs, and then weekly, after insertion

  • percentage requiring dilation and curettage

    24hrs, and then weekly, after insertion

  • failure to expel products of conception

    24hrs, and then weekly, after insertion

  • change in hematocrit

    24hrs, and then weekly, after insertion

  • side effects

    24hrs, and then weekly, after insertion

  • BHCG level

    24hrs, and then weekly, after insertion

Study Arms (2)

A

ACTIVE COMPARATOR

Four 200 ug tablets of Misoprostol

Drug: Misoprostol

B

PLACEBO COMPARATOR
Drug: Misoprostol

Interventions

MisoprostolDRUG

400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.

Also known as: Cytotec
AB

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant patients with nonviable pregnancy document by ultrasound
  • Gestation at or less than 13 weeks by ultrasound measurements
  • Clinically stable as determined by provider
  • Afebrile
  • Hematocrit \> 30
  • Over 18 years of age

You may not qualify if:

  • History of allergy to, or intolerance of, misoprostol
  • Refusal to abstain from intercourse for 72 hours
  • Significant vaginal bleeding (\> 2 pad/hr)
  • History of inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jasmine Han, MD

    Madigan Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 24, 2007

Study Start

March 1, 1999

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

February 8, 2008

Record last verified: 2008-02

Locations

US(1)