Optimum Misoprostol Dose Prior to Office Hysteroscopy | NCT01612065

Studies
Optimum Misoprostol Dose Prior to Office Hysteroscopy

NCT01612065

Sponsor

Cairo University

Status

Completed

Last Update Posted

Apr 11, 2013Estimated

Enrollment

132Actual

Phase

Phase 3

Conditions

Infertility
Abnormal Uterine and Vaginal Bleeding, Unspecified
Recurrent Abortion

Interventions

Misoprostol
Misoprostol

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

May 28, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Waleed El-khayat, Assistant professor of obstetrics and gynecology, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

Detailed Description

The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	200 ug	Misoprostol vaginally, 200 ug
Misoprostol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	Pain score by VAS	1year

Secondary Outcomes

Measure	Description	Time Frame
Easiness	ease of entry of the office hysteroscopy into the cervix recorded on a 5-point Likert scale: very difficult= 1, difficult = 2, fair = 3, easy = 4, and very easy = 5;	1year
Duration of the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Waleed El-khayat, M.D.	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr alainy hospital, faculty of medicine , Cairo university		Cairo		12211	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D014592	Uterine Hemorrhage
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided