A comparison of subcutaneous versus intramuscular depot medroxyprogesterone acetate as a choice of contraceptive method
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- (1) Percentage of women willing to continue subcutaneous Depot medroxyprogesterone acetate (DMPA) as contraceptive method.
研究概览
简要总结
With the help of Random allocation software 2.0, recruited patients will be allocated into 2 groups. Women in reproductive age group (18-45 years) attending family planning clinic in Department of Obstetrics and Gynecology, Lok Nayak Hospital, willing to use injection DMPA and fulfilling the inclusion and exclusion criteria will be recruited in the study. After obtaining an informed consent, a detailed demographic, menstrual, obstetrical, past medical and surgical history will be taken. General physical and local examination will be done. Detailed contact information will be taken for further follow up.
Group 1 will be receiving subcutaneous and Group 2 will be receiving intramuscular DMPA injection.
Subcutaneous DMPA is given in the back of the upper arm, in the abdomen (but not at the navel) and on the front of the thigh. It is given through Uniject prefilled injection system. The dose is 104 mg in 0.65 ml of injectable suspension.
Intramuscular DMPA is given deep into the hip (ventrogluteal muscle), the upper arm (deltoid muscle), or the buttocks (upper outer portion of gluteal muscle), whichever the women prefers. It is given through a 2 ml syringe and 21-23 gauge intramuscular needle after loading the dose through glass vial. The dose is 150 mg in 1 ml of aqueous solution as a single dose.
Next injection appointment date will be noted for each enrolled patients for follow up.
The women will be followed up for second injection and will perform detailed follow up surveys at the second injection or upon discontinuation. History will be taken at next 3 monthly visit of the patient regarding any side-effects (Weight gain, headache, breast tenderness, prolonged and heavy bleeding, intermenstrual bleeding, spotting, oligomenorrhea and amenorrhea), whether willing to continue the contraceptive injection, any unexpected pregnancy (contraceptive failure), reason for discontinuation of subcutaneous vs intramuscular DMPA injection.
They will be contacted at baseline and after 3 months to know if there are any practical barriers to continuation.
Outcomes will be measured as
(1)User acceptability and continuation rates
(2)Side effects
Relevant statistical analysis will be performed using SPSS-25 version
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women giving informed consent for receiving DMPA and ready to follow up visits every 3 months and are falling in category 1 or 2 of WHO Medical Eligibility Criteria for injection DMPA in following phases; a.
- •Post menstrual b.
- •Post abortal c.
- •6 weeks post delivery.
排除标准
- •Women with prior history of menstrual irregularities.
结局指标
主要结局
(1) Percentage of women willing to continue subcutaneous Depot medroxyprogesterone acetate (DMPA) as contraceptive method.
时间窗: 12 months
(2) Percentage of women willing to continue intramuscular DMPA as contraceptive method
时间窗: 12 months
次要结局
- (1) Percentage of women having side effects with subcutaneous DMPA.((2) Percentage of women having side effects with intramuscular DMPA.)
研究者
Dr Neha kumari
maulana azad medical college