CTRI/2024/08/072917招募中不适用
A prospective, interventional, comparative study to evaluate the insertion of postpartum intrauterine contraceptive device using the dedicated inserter versus Kelly forceps.
Dr Palak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 To assess the correct fundal placement of PPIUCD in the uterus.
研究概览
简要总结
The study is a prospective , interventional , comparative study to evaluate the insertion of postpartum intrauterine contraceptive device using the dedicated inserter versus Kelly forceps which is the conventional method ; in terms of fundal placement , ease of insertion for doctor , patient’s perception of pain and any complications .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Primiparous or multiparous women delivering vaginally and willing for long term reversible contraception.(Including instrumental deliveries ) 2 Consenting and willing for Copper T IUD.
- •3 Patients who fulfil the WHO Medical eligibility criteria for contraceptive use 4 Insertion within 48 hours following delivery.
排除标准
- •1 women not willing to participate 2 women with pelvic inflammatory disease 3 cesarean delivery 4 peri partum fever 5 women with anaemia , thrombocytopenia 6 women with postpartum haemorrhage 7 women with chorioamnionitis.
结局指标
主要结局
1 To assess the correct fundal placement of PPIUCD in the uterus.
时间窗: Immediately after insertion and at 6 weeks postpartum.
2 To assess provider’s satisfaction in terms of ease of insertion using five- point LIKERT scale.
时间窗: Immediately after insertion and at 6 weeks postpartum.
次要结局
- 1 To assess patients’ satisfaction and perception of pain using three-point LIKERT scale.(2 Confirmation of PPIUCD retention by a six-week follow-up.)
研究者
Dr Palak
Postgraduate institute of medical education and research ,Chandigarh
研究点 (1)
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