Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Removal rate of contraceptive implants users
研究概览
简要总结
To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.
详细描述
- To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.
- Participants who wish to attend the study will be invited to choose between Levonorgestrel and Etonogestrel contraceptive implant, then they will be randomized into immediate postpartum or delay postpartum group. They will be follow-up at 6 and 12 weeks after receive contraceptive implant.
- Information about side effects, breastfeeding status, child growth, acceptability and tolerance will be noted using medical records and interviewing, gathering on paper case record forms.
- Sample size N = 60 (30 in each group (Immediate and delay postpartum group, 15 in each subgroup (Levonogestrel and Etonogestrel group)) This number of sample size is already counted with 10% data loss
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant
排除标准
- •Woman who has any medical conditions which is considered contraindicated to use contraceptive implant
- •Woman with severe antepartum or peripartum complications
- •Woman who is contraindicated to breastfeed.
研究组 & 干预措施
Levonorgestrel immediate post-partum
Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 48-72 hr after child delivery
干预措施: Levonorgestrel Drug Implant (Drug)
Etonogestrel immediate post-partum
Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 48-72 hr after child delivery
干预措施: Etonogestrel Drug Implant (Drug)
Levonorgestrel delayed post-partum
Breast-feeding postpartum woman who receive Levonorgestrel drug implant (75 mg) between 5-7 weeks after child delivery
干预措施: Levonorgestrel Drug Implant (Drug)
Etonogestrel delayed post-partum
Breast-feeding postpartum woman who receive Etonogestrel drug implant (68 mg) between 5-7 weeks after child delivery
干预措施: Etonogestrel Drug Implant (Drug)
结局指标
主要结局
Removal rate of contraceptive implants users
时间窗: immediately after contraceptive implant use until 12 weeks after use
To compare tolerance between Immediate and delayed breastfeeding postpartum contraceptive users, by collecting and calculating removal rate of users.
Satisfactory of contraceptive implant users
时间窗: immediately after contraceptive implant use until 12 weeks after use
To compare acceptability between Immediate and delayed breastfeeding postpartum contraceptive users, using questionnaire rating satisfactory scale by score from 1 to 5
Number of participants with treatment-related adverse events
时间窗: immediately after contraceptive implant use until 12 weeks after use
To compare treatment-related adverse events between Immediate and delayed breastfeeding postpartum contraceptive users, using case record form which specify bleeding days, spotting days, abdominal discomfort, headache, acne, alopecia, weight and blood pressure of users.
次要结局
- Breastfeeding status(immediately after contraceptive implant use until 12 weeks after use)
- Child weight(immediately after contraceptive implant use until 12 weeks after use)
- Child height(immediately after contraceptive implant use until 12 weeks after use)