Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- the difference in the pain intensity scores between the study groups
研究概览
简要总结
To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.
详细描述
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind randomized trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant women
- •Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
- •Women who delivered only by cesarean section
排除标准
- •Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
- •Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
- •Allergy to isonicotinic acid hydrazide .
- •Women refuse to participate in the study
研究组 & 干预措施
INH
3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
干预措施: INH (Drug)
Placebo Comparator
3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
the difference in the pain intensity scores between the study groups
时间窗: 10 minutes
the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain
次要结局
- Provider ease of insertion(10 minutes)
- insertion time(10 minutes)
研究者
hany farouk
A Professor
Aswan University Hospital