NCT01156948

Brief Summary

To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 8, 2010

Status Verified

May 1, 2008

Enrollment Period

2.3 years

First QC Date

July 2, 2010

Last Update Submit

July 7, 2010

Conditions

Cervical Ripening

Keywords

misoprostolnulliparoushysteroscopy

Outcome Measures

Primary Outcomes (1)

  • cervical width

    one day

Secondary Outcomes (1)

  • side effects

    one day

Study Arms (2)

vaginal misoprostol

ACTIVE COMPARATOR

vaginal misoprostol was administered to this group of nulliparous women

Drug: misoprostol

oral misoprostol

EXPERIMENTAL

oral misoprostol

Drug: oral misoprostol

Interventions

misoprostolDRUG

400ug vaginally the day before surgery

vaginal misoprostol
oral misoprostolDRUG

400ug misoprostol orally the day before the surgery

oral misoprostol

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.

You may not qualify if:

  • women with a known allergy to misoprostol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 1st Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Feng Lin

    the 1st affiliated hospital of Wenzhou Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

May 1, 2008

Primary Completion

August 1, 2010

Study Completion

December 1, 2011

Last Updated

July 8, 2010

Record last verified: 2008-05

Locations

CN(1)