Comparison of The Effect of Etonogestrel Subdermal Single Rod Implant and Depot Medroxyprogesterone Acetate on Menstrual Pattern: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Both Etonogestrel single rod subdermal implant and DMPA have high efficacy, least failure rates and user friendly temporary contraceptive methods but discontinued most commonly due to menstrual irregularities. There is paucity of studies comparing the above two progesterone based long acting reversible contraceptive (LARC) methods.Both methods are freely available by GoI, studies comparing the two methods may help counselling the women opting for either of the two methods and increase the acceptance and continuation rate.
Using sequential computer-generated block randomization study participants will be divided into two arms, arm A and arm B, with 1:1 allocation ratio
ARM A: Women will receive Subdermal etonogestrel Implant insertion.
ARM B: Women will receive intramuscular DMPA injections.
Subjects in both the arms will be given PBAC charts for 90 days for tracking bleeding patterns in these females. The subjects will be followed at 3 months after contraceptive administration. They will be assessed for general and physical examination and menstrual changes will be assessed with PBAC charts.
If female has disturbed menstrual pattern or amenorrhea, UPT will be done.
Women in both arms will be assessed for side effects, satisfaction, willingness to continue the current method of contraception and failure rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Willing to participate in the study and for follow up at 3 months.
- •Age group of 18-40 years
- •Desire a highly effective temporary method of contraception.
排除标准
- •1.Undiagnosed genital bleeding 2.Less than 6 weeks postpartum 3.Active thrombophlebitis or thromboembolic disease
- •Acute liver disease, benign or malignant liver tumors
- •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.
结局指标
主要结局
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.
时间窗: 3 months.
次要结局
- 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.(2. Proportion of women very unsatisfied, unsatisfied, neutral, satisfied, very satisfied in arm A and B assessed at 3 months of use.)
研究者
Nisha R
Lady Hardinge medical college and Associated hospitals