Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: 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 pain scores during intrauterine device insertion
研究概览
简要总结
To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
详细描述
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
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 controlled 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 such as congenital anomalies, endometrial lesions, adenomyosis, or 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
- •known psychiatric disorders ( anxiety and depression) and chronic use of medications that could interfere with pain perception (antidepressants and anticonvulsants)
- •Women refuse to participate in the study
研究组 & 干预措施
INH
3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.
干预措施: INH (Drug)
Placebo Comparator
one tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
The difference in pain scores during intrauterine device insertion
时间窗: 10 minutes
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
次要结局
- duration of IUD insertion(10 minutes)
研究者
hany farouk
A Professor
Aswan University Hospital