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Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial


N/A
35 Years
N/A
Open (Enrolling)
Female
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

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Trial Information

Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial


Inclusion Criteria:



- thai women at the age over 35 years old

- presenting with abnormal uterine bleeding and have a plan to perform fractional
curettage

Exclusion Criteria:

- uterine anomalies

- pregnancy

- pelvic inflammatory disease

- uncontrolled medical or psychological conditions

- known cases of gynecological diseases such as gynecological malignancies, abnormal
pap smear

- Prostaglandin allergy

- Contraindicate to prostaglandin: asthma, mitral valve stenosis, glaucoma, sickle cell
anemia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding

Outcome Description:

an efficacy of sublingual misoprostol in this study was dilatation of uterine cervix which was measured by a diameter of MVA cannula in millimeters.

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Korakot Sirimai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mahidol University

Authority:

Thailand: Ethical Committee

Study ID:

SIOGMVA002

NCT ID:

NCT01762319

Start Date:

November 2012

Completion Date:

June 2013

Related Keywords:

  • Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
  • Hemorrhage
  • Metrorrhagia
  • Uterine Hemorrhage
  • Adenoma

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