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Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01762319
Enrollment
52
Registered
2013-01-07
Start date
2012-11-30
Completion date
2013-06-30
Last updated
2013-01-07

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

Conditions

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Brief summary

Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic procedure of this condition. Traditionally, fractional curettage is performed under local anesthesia such as paracervical nerve block or intravenous meperidine. Cervical dilatation using metal cervical dilator is a common method prior to perform fractional curettage. However, complication from this procedure can be occurred frequently, for example, uterine perforation, false tract formation and laceration of cervix. Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and gynecology. Misoprostol transforms cervical component causing cervical ripening. This is very helpful for transcervical procedure because cervical dilatation is usually omitted. It can be prescribed in many route and sublingual route is the most effectiveness. Moreover, WHO supports the use of misoprostol in obstetrics and gynecology practice. The hypothesis of this study is that Misoprostol 200 micrograms sublingually is effective for cervical ripening before performing fractional curettage in patients with abnormal uterine bleeding Double blind randomised controlled trial was performed using 26 patients in each group.

Interventions

DRUGMisoprostol

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
efficacy of 200 microgram Misoprostol for cervical ripening prior to performing fractional curettage in patients with abnormal uterine bleeding1 Yearan efficacy of sublingual misoprostol in this study was dilatation of uterine cervix which was measured by a diameter of MVA cannula in millimeters.

Countries

Thailand

Contacts

Primary ContactKorakot Sirimai, Dr.
ksirimai@hotmail.com(66)81-6140655

Outcome results

None listed

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