USE OF THERMAL BALLOON ABLATION IN HEAVY BLEEDING DUE TO FIBROIDS

THERMAL BALLOON ABLATION IN MYOMA INDUCED HEAVY MENSTRUAL BLEEDING

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/07/007119

Enrollment

Registered

2016-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- PATIENTS OF HEAVY MENSTRUAL BLEEDING IN UTERINE MYOMA UPTO 5 CM

Interventions

Intervention1: THERMAL BALLOON ABLATION: THERMAL BALLOON ABLATION was done in patients with heavy menstrual bleeding due to fibroids upto 5 cm Control Intervention1: VAGINAL HYSTERECTOMY: VAGINAL HYST

Eligibility

Inclusion criteria

Inclusion criteria: heavy menstrual bleeding PBAC more than 100 family completed uterine size less than or equal to 14 weeks largest fibroid of less than or equal to 5 centimeters fibroid of subtype 3 to 5 uterocervical length not more than 12 centimeters

Exclusion criteria

Exclusion criteria: acute pelvic inflammatory disease any pelvic pathology adenomyosis any gynecological cancer atypical hyperplasia or worse on endometrial pathology submucosal myoma

Design outcomes

Primary

Measure	Time frame
reduction in menstrual blood loss PBAC score improvement in hemoglobin levels intraoperative and postoperative eventsTimepoint: reduction in menstrual blood loss PBAC score 1, 3, 6 months post treatment improvement in hemoglobin levels 1,3,6 months post treatment intraoperative events postoperative pain VAS score at 4,6,12,24,48,72 hours post treatment immediate and late post operative complications	—

Measure

Time frame

reduction in menstrual blood loss PBAC score improvement in hemoglobin levels intraoperative and postoperative eventsTimepoint: reduction in menstrual blood loss PBAC score 1, 3, 6 months post treatment improvement in hemoglobin levels 1,3,6 months post treatment intraoperative events postoperative pain VAS score at 4,6,12,24,48,72 hours post treatment immediate and late post operative complications

—

Secondary

Measure	Time frame
UTERINE FIBROID SYMPTOM QUALITY OF LIFE questionnaire scoreTimepoint: pretreatment and 6 months post operative	—

Countries

India

Contacts

Public ContactPRACHI JAIN

UNIVERSITY COLLEGE OF MEDICAL SCIENCES

rajaram.shalini@gmail.com9868399750

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 1, 2026