不明部位妊娠(PUL)不是诊断,而是一种短暂的状态,用于对女性进行分类,当她的妊娠试验阳性时,没有经阴道超声检查的子宫内或子宫外妊娠的明确证据。持续PUL的管理变化很大,包括预期或积极管理。主动管理可包括子宫腔排空或氨甲蝶呤的全身给药。迄今为止,对于两种管理策略是否优于另一种,尚未达成共识。
随机对照试验。
学术医疗中心。
我们计划从生殖医学网络诊所和其他感兴趣的网站随机分配276名18岁或以上的持续PUL诊断女性。对所有患者的生育能力和患者满意度进行2年随访.
随机化将是预期管理之间的1:1:1比例,子宫排空和经验性使用甲氨蝶呤。在随机分配到初始管理计划后,所有患者将由临床医生随访,直至PUL消退.临床医生将确定管理是否有变化,根据临床症状,和/或系列人绒毛膜促性腺激素(hCG)浓度和/或其他超声检查。
在3个治疗组中的每个治疗组中的主要结果指标是持续性PUL的平稳临床解决,而不改变最初的管理策略。次要结果指标包括:异位妊娠破裂的数量,重新干预的数量和类型(额外的甲氨蝶呤注射或外科手术),治疗并发症,不良事件,访问次数,时间到决议,患者满意度,未来的生育率。
这项多中心随机对照试验将为不明部位持续妊娠妇女的循证管理提供指导。
Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other.
Randomized controlled trial.
Academic medical centers.
We plan to randomize 276 persisting PUL-diagnosed women who are 18 years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2 years for fertility and patient satisfaction outcomes.
Randomization will be 1:1:1 ratio between expectant management, uterine evacuation and empiric use of methotrexate. After randomization to initial management plan, all patients will be followed by their clinicians until resolution of the PUL. The clinician will determine whether there is a change in management, based on clinical symptoms, and/or serial human chorionic gonadotropin (hCG) concentrations and/or additional ultrasonography.
The primary outcome measure in each of the 3 treatment arms is the uneventful clinical resolution of a persistent PUL without change from the initial management strategy. Secondary outcome measures include: number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility.
This multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.