Comparison of The Effect of Implant and injectable contraceptive on Menstrual Patter
Phase 4
- Registration Number
- CTRI/2024/07/071211
- Lead Sponsor
- isha R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Willing to participate in the study and for follow up at 3 months.
2. Age group of 18-40 years
3. Desire a highly effective temporary method of contraception
Exclusion Criteria
1.Undiagnosed genital bleeding
2.Less than 6 weeks postpartum
3.Active thrombophlebitis or thromboembolic disease
4. Acute liver disease, benign or malignant liver tumors
5. Known or suspected breast cancer
6.Women with known case of depression or other mental Health disorder
7.On drugs induced by liver enzymes or drugs that interfere with coagulation
8.Severe cardiovascular disease
9.Severe hirsutism
10.Any skin infection at the local site of the proposed injection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of women with changed menstrual patterns (bleeding/spotting episodes, prolonged bleeding, frequent bleeding, infrequent bleeding, irregular bleeding and amenorrhea, as per FIGO criteria) at 3 months follow up in women initiated on Etonogestrel single rod Subdermal Implant and Depot-Medroxyprogesterone Acetate Injection.Timepoint: 3 months.
- Secondary Outcome Measures
Name Time Method 1.Proportion of women with side effects (pain at site of insertion/ injection, headache, dizziness, mood swings, weight gain, breast pain, abdominal pain, any other) in arm A and B assessed at 3 months of use. <br/ ><br>2. Proportion of women very unsatisfied, unsatisfied, neutral, satisfied, very satisfied in arm A and B assessed at 3 months of use. <br/ ><br>3. Proportion of women who chose to continue the current contraceptive method at 3 months of follow up in arm A and B. <br/ ><br>4. Proportion of women who became pregnant during the use of the chosen method at 3 months of use in arm A and B. <br/ ><br>Timepoint: 3 months