The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Post-HSG Pain Questionnaire
研究概览
简要总结
The hysterosalpingogram (HSG) is the gold standard of assessing fallopian tube patency and involves the placement of a transcervical catheter to allow for instillation of radio-opaque dye into the uterine cavity and fallopian tubes which are then imaged with abdominal x-ray. A common side effect of the instillation of dye is the uterine cramping, which is both uncomfortable for the patient as well as can cause iatrogenic proximal occlusion of the fallopian tubes. Proximal tubal obstruction is often not representative of true tubal obstruction but is rather an artifact of the test. Prior studies measuring the perceived pain and cramping during HSG have been conducted which have shown reduced pain scores and decreased uterine cramping when warmed contrast dye is used. The researchers propose that the use of warmed contrast media during HSG will be correlated with decreased pain scores and fewer cases of proximal tubal occlusion in women with otherwise normal uterine anatomy.
详细描述
Research materials will include obtaining patient past medical history at time of the patient screening and recruitment, via utilization of Epic to search for demographic factors including age, height, weight, BMI, race/ethnicity, duration of infertility, past medical history, and gynecologic/obstetric history.
Post-procedure images from the HSG/report of the HSG findings will be saved in Epic as per usual standard clinical practice. HSG findings will be transcribed with prior demographics/history into a PHI-safe RedCap. No biospecimens will be collected under this protocol.
Patients undergoing fertility treatment that are recommended to undergo HSG as part of their evaluation will be referred to a dedicated research nurse (RN) for eligibility screening and informed consent.
Once found to be meeting inclusion criteria, the patient will be consented and scheduled for HSG as appropriate for their menstrual cycle and clinical care. Typically, patients are scheduled during cycle day 5-10 of their menstrual cycle for best study image quality.
Once scheduled, the patient will be randomized to warmed (body temperature) vs cold (room temperature) HSG. The principal investigator will create a computer-generated randomization table (1:1) using block randomization with randomly varying block size of 4 and 6 without stratification.
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
- Double (Participant, Investigator)
盲法说明
This study will be blinded in a manner that the research nurse, patient, and provider will not be aware of patient allocation at time of recruitment and enrollment. The patient will be assigned a unique study ID number and the randomization module in REDCap will be used to assign the participant to either the experimental (warm) or control (cold) group.
The patient will remain blinded to the treatment allocation but the research nurse and performing provider will be unblinded to allow for correct choice and use of warm versus cold contrast media. As both the research nurse and provider will touch the HSG contrast media and be able to discern if it is cold or warm, it is impossible to maintain blinding of the research team.
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
- •1. Women ages 18-45 undergoing tubal assessment via HSG.
排除标准
- •History of fibroids
- •History of pelvic inflammatory disease (PID or STD including gonorrhea, chlamydia, or trichomonas)
- •History of surgically diagnosed endometriosis or suspected endometriosis on ultrasound (indicated by visualization of likely endometrioma)
- •History of ectopic pregnancy or 3 or more biochemical pregnancies/pregnancy of unknown location
- •History of tubal or ovarian surgery
- •History of known Mullerian anomaly
- •History of pelvic surgery including appendectomy
- •Allergy to iodine-based contrast media
- •History of prior abnormal fallopian tubes on HSG
- •History of ultrasound with hydrosalpinx (unilateral or bilateral)
研究组 & 干预措施
Cold HSG
HSG contrast will be standard, room-temperature
Warm HSG
HSG constrast will be warmed.
干预措施: Warmed HSG (Drug)
结局指标
主要结局
Post-HSG Pain Questionnaire
时间窗: Measured 1 hour after HSG procedure
To compare the patient experience for patients undergoing HSG when warm versus cold contrast media is utilized, patients will complete a post-HSG Questionnaire to indicate their level of pain.
次要结局
- Rate of unilateral and bilateral proximal fallopian tube occlusion(Measured at the time of HSG procedure)