The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
研究概览
简要总结
This was a randomized controlled trial of 400 women who attended the outpatient clinic of Menoufia University Hospital for copper IUD insertion. The women were randomly assigned to cough and control groups.The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
详细描述
We conducted this randomized controlled trial at the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt, from May 2018 to March 2020. Our hospital research ethics committee approved this study. We obtained informed consent from all participants before initiating any study procedures. CONSORT guidelines were observed and completed.
We recruited non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception. Eligible women had no prior vaginal delivery or pregnancy termination beyond 12 weeks, gestation (as patulous cervical os may affect VAS score), any previous deliveries had been by cesarean section, they were immediately postmenstrual or 1 week after pregnancy termination and they were willing to complete the study questionnaires. All women had to be alert, oriented, and cooperative to respond easily to VAS.
Exclusion criteria were current pregnancy, prior vaginal delivery, history of cervical stenosis, current pelvic inflammatory disease, uterine anomalies, undiagnosed abnormal uterine bleeding, fibroids distorting the uterine cavity, and patients using chronic NSAIDs or on chronic pain medication.
We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception.
- •No prior vaginal delivery or pregnancy termination beyond 12 weeks gestation (as patulous cervical os may affect VAS score).
- •Any previous deliveries had been by cesarean section.
- •Immediately postmenstrual or 1 week after pregnancy termination.
- •They were willing to complete the study questionnaires.
- •All women had to be alert, oriented, and cooperative to respond easily to VAS.
- •Exclusion criteria were:
- •Current pregnancy.
- •Prior vaginal delivery.
- •History of cervical stenosis.
- •Current pelvic inflammatory disease.
- •Uterine anomalies.
- •Undiagnosed abnormal uterine bleeding.
- •Fibroids distorting the uterine cavity.
- •Patients using chronic NSAIDs or on chronic pain medication. We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent
排除标准
- 未提供
结局指标
主要结局
The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
时间窗: Up to 22 months
The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).
次要结局
未报告次要终点
研究者
Nabih Elkhouly
Asssistant professor of obstetrics and gynecology
Menoufia University