To Compare the Efficacy Of Tablet Ulipristal Acetate with inj GnRH agonist in Women with Fibroid Uterus
- Conditions
- Health Condition 1: null- myoma
- Registration Number
- CTRI/2016/10/007336
- Lead Sponsor
- ot Applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 64
1.Age group: 21 to 49 years of age.
2.Uterus size <= 18 weeks on bimanual examination.
3.Ultrasonography suggestive of at least one uterine myoma of >= 3 cm diameter in size.
4.Provide informed written consent.
1.Uterine size > 18 weeks on clinical examination.
2.Any single myoma size > 10 cm on ultrasonography.
3.Treatment with any hormonal preparation within 3 months of recruitment.
4.History of myomectomy.
5.History of uterine artery embolization.
6.Known case of uncontrolled thyroid disorders, liver disease, hemoglobinopathy coagulation disorder.
7.Large uterine polyp ( >2 cm), Submucosal fibroid (class 0 under myoma sub classification system).
8.Ovarian cysts >=4 cm in diameter as measured by ultrasound.
9.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (a) Fibroid volume as assessed by USG <br/ ><br>(b) Pictorial blood loss assessment chart (PBAC) Score.Timepoint: Baseline, 3month, 6 month
- Secondary Outcome Measures
Name Time Method (a) Pain measured with the use of Visual analogue scale (VAS) scoreTimepoint: Baseline, 3month, 6 month;(b) Pulsatility index, Resistivity index of uterine Arteries.Timepoint: Baseline, 3month, 6 month