Use of misoprostol before hyteroscopy exam to evaluate intrauterine in postmenopausal women.

Use of misoprostol prior to hysteroscopy in postmenopausal women: a randomised, placebo-controlled clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-9py4kd

Enrollment

Unknown

Registered

2015-09-17

Start date

2015-11-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Endometrial polyps. Postmenopausal bleeding.

Interventions

Group: 91 postmenopausal women use vaginal 1 tablet of misoprostol 200mg 8 hours before hysteroscopy. Control group: 91 postmenopausal women use 1 tablet placebo 8 hours before hysteroscopy. Randomize

Drug

Procedure/surgery

D10.251.355.255.550.700.450.500

E01.370.378.330

Eligibility

Sex/Gender

Female

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 182 Menopausal women with minimum age of 50 and maximum of 80 referred for endometrial assessment by hysteroscopy.

Exclusion criteria

Exclusion criteria: Women with lower genital tract infection. Women who have had intrauterine diseases that were previously treated by endoscopy. Women who have never had sexual relations; with uterine malformation; with mental disabilities or undergoing pelvic radiotherapy.Women who refused to participate in the study.Women who had metrorrhagia during the exam.

Design outcomes

Primary

Measure	Time frame
EXPECTED OUTCOME: Lower pain during the procedure, the clamping of the cervix and at the time of biopsy will evaluete by visual pain score that will show lower values in the misoprostol group.	—

Secondary

Measure	Time frame
EXPECTED OUTCOME: Equal need for cervical dilatation between groups ( misoprostol or placebo) that will be evaluated by the passage of a hysteroscope through the cervix and / or dilation of the external orifice using Hegar number 1 to 4.;EXPECTED OUTCOME: Similar procedure time between groups (misoprostol or placebo)that will be evaluated by timer starting in the passage of the hysteroscope through the cervix and ending the withdrawal the instrument, measured in minutes.;EXPECTED OUTCOME: The frequency of side effects will be 5% and will be evaluated by the account of the women that will show little effects by drugs.;EXPECTED OUTCOME: Less cost-effective with the use of misoprostol in hysteroscopy that will be evaluated by pharmacoeconomic study to assess how misoprostol reduce the number of hysteroscopy under anesthesia.	—

Measure

Time frame

EXPECTED OUTCOME: Equal need for cervical dilatation between groups ( misoprostol or placebo) that will be evaluated by the passage of a hysteroscope through the cervix and / or dilation of the external orifice using Hegar number 1 to 4.;EXPECTED OUTCOME: Similar procedure time between groups (misoprostol or placebo)that will be evaluated by timer starting in the passage of the hysteroscope through the cervix and ending the withdrawal the instrument, measured in minutes.;EXPECTED OUTCOME: The frequency of side effects will be 5% and will be evaluated by the account of the women that will show little effects by drugs.;EXPECTED OUTCOME: Less cost-effective with the use of misoprostol in hysteroscopy that will be evaluated by pharmacoeconomic study to assess how misoprostol reduce the number of hysteroscopy under anesthesia.

—

Countries

Brazil

Contacts

Public ContactDaniela Yela

Universidade Estadual de Campinas - Unicamp

yela@unicamp.br+55(19)35219306

Outcome results

None listed

Source: REBEC (via WHO ICTRP)