NCT01612065

Brief Summary

Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2012

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

May 28, 2012

Last Update Submit

April 10, 2013

Conditions

InfertilityAbnormal Uterine and Vaginal Bleeding, UnspecifiedRecurrent Abortion

Keywords

Office hysteroscopyCervical primingMisoprostol

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Pain score by VAS

    1year

Secondary Outcomes (2)

  • Easiness

    1year

  • Duration of the procedure

    1year

Study Arms (2)

Misoprostol vaginally, 200 ug

ACTIVE COMPARATOR

200 ug misoprostol in the posterior vaginal fornix

Drug: Misoprostol

Misoprostol vaginally, 400ug

ACTIVE COMPARATOR

Misoprostol in the posterior vaginal fornix

Drug: Misoprostol

Interventions

MisoprostolDRUG

200 ug

Misoprostol vaginally, 200 ug

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female patient pre- or postmenopausal undergo office hysteroscopy.
  • Age: from 20 to 60.
  • BMI between 18 and 30.

You may not qualify if:

  • PID or
  • Heavy uterine bleeding
  • Cervical malignancy.
  • Symptoms suggestive of endometriosis .
  • Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy hospital, faculty of medicine , Cairo university

Cairo, 12211, Egypt

Location

MeSH Terms

Conditions

InfertilityUterine HemorrhageAbortion, Habitual

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsAbortion, SpontaneousPregnancy Complications

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Waleed El-khayat, M.D.

    Cairo University

    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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of obstetrics and gynecology

Study Record Dates

First Submitted

May 28, 2012

First Posted

June 5, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

EG(1)