Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.
RTI International, Durham, North Carolina.
Am J Epidemiol. 2020 Aug 1;189(8):773-778. doi: 10.1093/aje/kwaa027.
We conducted a parallel, nonblinded randomized trial to assess whether offering home pregnancy tests (HPTs) to preconception cohort study participants influenced cohort retention or pregnancy detection. Pregnancy Study Online participants were female, aged 21-45 years, attempting pregnancy, and not using fertility treatment. At enrollment (2017-2018), 1,493 participants with 6 or fewer cycles of attempt time were randomly assigned with 50% probability to receive 12 Clearblue visual HPTs plus the standard protocol (n = 720) or the standard protocol alone (n = 773). Women completed bimonthly questionnaires for 12 months or until conception, whichever came first. In intent-to-treat analyses, retention (≥1 follow-up) was higher in the HPT arm (n = 598; 83%) than the standard protocol arm (n = 535 (69%); mean difference = 15%, 95% CI: 10, 19). Mean time at first pregnancy testing was identical in both arms (2 days before expected menses), as was mean gestational weeks at first positive pregnancy test (4 weeks). Conception was reported by 78% of women in the HPT arm and 75% in the standard protocol arm. Spontaneous abortion was reported by 21% in the HPT arm (mean gestational weeks = 7) and 21% in the standard protocol arm (mean gestational weeks = 6). Randomization of HPTs was associated with greater cohort retention but had little impact on incidence or timing of pregnancy detection.
我们进行了一项平行、非盲随机试验,以评估向孕前队列研究参与者提供家庭妊娠试验(HPT)是否会影响队列保留或妊娠检测。妊娠在线研究参与者为女性,年龄在 21-45 岁之间,正在尝试怀孕,并且未使用生育治疗。在入组时(2017-2018 年),1493 名尝试时间为 6 个周期或更少的参与者以 50%的概率被随机分配接受 12 个可丽蓝视觉 HPT 加标准方案(n=720)或仅接受标准方案(n=773)。女性在 12 个月内每两个月完成一次问卷,或直到怀孕,以先到者为准。在意向治疗分析中,HPT 组的保留率(≥1 次随访)(n=598;83%)高于标准方案组(n=535(69%);平均差异=15%,95%CI:10,19)。在两个组中,首次妊娠检测的平均时间相同(预计月经前 2 天),首次妊娠阳性检测的平均妊娠周数也相同(4 周)。HPT 组有 78%的女性报告怀孕,标准方案组有 75%的女性报告怀孕。HPT 组自发性流产率为 21%(平均妊娠周数=7),标准方案组为 21%(平均妊娠周数=6)。HPT 的随机分组与更高的队列保留率相关,但对妊娠检测的发生率或时间几乎没有影响。