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Use of Vaginal Misoprostol to Relieve Pain During Operative Hysteroscopy in Office Setting: A Randomized Double-Blinded Placebo Controlled Study

Use of Vaginal Misoprostol to Relieve Pain During Operative Hysteroscopy in Office Setting: A Randomized Double-Blinded Placebo Controlled Study

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230621006
Enrollment
78
Registered
2023-06-21
Start date
2023-05-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Reproductive age women who had intrauterine lesion that require Operative Hysteroscopy in office setting Misoprostol, Operative Hysteroscopy, office setting, visual analog scale

Interventions

Misoprostol 200 mcg 1 tab vaginal suppository 12 hours before office operative hysteroscopy ,Vitamin B6 100 mg 1 tab vaginal suppository 12 hours before office operative hysteroscopy
Experimental Drug,Placebo Comparator Drug
Misoprostol group,Placebo group

Sponsors

None listed

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1 Women who had an appointment for operative hysteroscopy in outpatient department at ramathibodi hospital 2 age 18-50 years and in reproductive age 3 pelvic examination can done 4 BMI 18-30 kg/m2 5 Have confirm test from ultrasound or diagnostic hysteroscopy that have intrauterine lesion that require surgery such as endometrial polyp, myoma uteri size less than 3 cm., intrauterine adhesion, uterine septum, foreign body 6 Be willing to participate in the research and sign a consent letter

Exclusion criteria

Exclusion criteria: 1 Have contraindication for hysteroscopy such as pregnancy, pelvic inflammatory disease, suscepted cervical cancer or advance stage endometrial cancer 2 Underlying disease such as asthma, chronic kidney disease or hepatitis 3 Allergy to Misoprostol, NSIADs 4 Cervical stenosis or history cervical operation

Design outcomes

Primary

MeasureTime frame
Compared efficacy of the use of misoprostol to relieve pain during operative hysteroscopy in office setting compared with placebo During office hysteroscopy Visual analog scale

Secondary

MeasureTime frame
Compared efficacy of the use of misoprostol to relieve pain before operative hysteroscopy in office setting compared with placebo Before office hysteroscopy Visual analog scale,Compared efficacy of the use of misoprostol to relieve pain during dilate cervix in operative hysteroscopy in office setting compared with placebo During dilate cervix Visual analog scale,Compared efficacy of the use of misoprostol to relieve pain during apply hysteroscopy into uterine cavity in operative hysteroscopy in office setting compared with placebo During apply hysteroscope Visual analog scale,Compared efficacy of the use of misoprostol to relieve pain 5 minutes after operative hysteroscopy in office setting compared with placebo 5 minutes after operative hysteroscopy Visual analog scale,Compared efficacy of the use of misoprostol to relieve pain 15 minutes after operative hysteroscopy in office setting compared with placebo 15 minutes after operative hysteroscopy Visual analog scale,Require for additional pain killer after each intervention After office hysteroscopy yes/no ,Comparison of duration of cervical dilatation During dilate cervix time,Comparison of duration of office hysteroscopy During office hysteroscopy time,Failure rate of office hysteroscopy During office hysteroscopy reteing of failure,side effect of Misoprostol drug After apply Misoprostol drug yes/no,Complication during the hysteroscopy During office hysteroscopy yes/no

Countries

Thailand

Contacts

Public ContactNicharnart Pongsuttipanit

Faculty of Medicine Ramathibodi Hospital

daow_night@hotmail.com0860309189

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026