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Optimum Misoprostol Dose Prior to Office Hysteroscopy

The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01612065
Enrollment
132
Registered
2012-06-05
Start date
2012-06-30
Completion date
2013-04-30
Last updated
2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Uterine and Vaginal Bleeding, Unspecified, Infertility, Recurrent Abortion

Keywords

Office hysteroscopy, Cervical priming, Misoprostol

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

Interventions

DRUGMisoprostol

200 ug

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain score1yearPain score by VAS

Secondary

MeasureTime frameDescription
Easiness1yearease 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;
Duration of the procedure1yearDuration of hysteroscopy in seconds

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026