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

M

Mahidol University

Status

Unknown

Conditions

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Treatments

Drug: Vitamin B6
Drug: Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT01762319
SIOGMVA002

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

Female

Ages

35+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

52 participants in 2 patient groups, including a placebo group

Misoprostol
Experimental group
Description:
200 mcg Misoprostol SL 1 hour prior to fractional curettage
Treatment:
Drug: Misoprostol
Vitamin B6
Placebo Comparator group
Description:
100 mg Vitamin B6 SL 1 hr prior to fractional curettage
Treatment:
Drug: Vitamin B6

Trial contacts and locations

1

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Central trial contact

Korakot Sirimai, Dr.

Data sourced from clinicaltrials.gov

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