Estes Christopher M, Ramirez Jahanett, Tiezzi Lorraine, Westhoff Carolyn
Department of Obstetrics and Gynecology, Columbia University, New York, NY 10032, USA.
Contraception. 2008 Jan;77(1):40-3. doi: 10.1016/j.contraception.2007.09.005. Epub 2007 Nov 26.
Immediate initiation of depo-medroxyprogesterone acetate (DMPA) increases continuation and decreases pregnancies compared to conventional (next menstrual period) initiation. A drawback is the need to return in 4 weeks for a repeat pregnancy test to identify any pregnancy that was too early to diagnose on the day of injection. If women can perform home pregnancy tests (HPTs) to detect human chorionic gonadotropin (hCG) in urine, the need for this follow-up visit may be eliminated. This study assesses whether women can perform their own HPT.
This is a single-visit observational trial of an HPT kit. Subjects recruited from a waiting room in an urban family planning clinic received an HPT kit with standard instructions to use immediately. Subjects and a research assistant each interpreted the test. Their results were then compared to a standard cassette type test for detection of hCG performed by clinic staff. kappa was calculated to assess the level of agreement.
Three hundred ten subjects enrolled. They were young (mean age, 25.2 years), mostly Hispanic (91%) women. A change in the font and explicitness of the instructions decreased the incidence of invalid tests from 12.7% to 4.8%. The subject and research assistant's interpretation of the test had a high level of agreement, kappa=0.95 [95% confidence interval (CI), 0.92-0.99]. There was also a high level of agreement between the subjects' results and the standard test, kappa=0.88 (95% CI, 0.82-0.95).
Women presenting for pregnancy testing at an urban clinic are able to perform HPTs with a high level of accuracy. The appearance of the instructions influenced the incidence of false-negative and invalid tests. Home pregnancy tests may be useful in follow-up protocols when immediate initiation of DMPA is employed.
与常规(下次月经期)开始使用相比,立即开始使用醋酸甲羟孕酮注射液(DMPA)可提高续用率并减少怀孕几率。一个缺点是需要在4周后返回进行重复妊娠试验,以确定在注射当天因太早而无法诊断出的任何妊娠情况。如果女性能够进行家庭妊娠试验(HPT)来检测尿液中的人绒毛膜促性腺激素(hCG),则可能无需进行此次随访。本研究评估女性是否能够自行进行HPT。
这是一项关于HPT试剂盒的单次就诊观察性试验。从城市计划生育诊所的候诊室招募的受试者收到一个HPT试剂盒,并附有立即使用的标准说明。受试者和一名研究助理各自对测试结果进行解读。然后将他们的结果与诊所工作人员进行的用于检测hCG的标准盒式试验结果进行比较。计算kappa值以评估一致性水平。
310名受试者入组。他们很年轻(平均年龄25.2岁),大多是西班牙裔(91%)女性。说明书字体和清晰度的改变使无效测试的发生率从12.7%降至4.8%。受试者和研究助理对测试结果的解读一致性很高,kappa = 0.95 [95%置信区间(CI),0.92 - 0.99]。受试者的结果与标准测试之间也有很高的一致性,kappa = 0.88(95% CI,0.82 - 0.95)。
在城市诊所进行妊娠检测的女性能够以很高的准确性进行HPT。说明书的外观影响了假阴性和无效测试的发生率。当立即开始使用DMPA时家庭妊娠试验可能在后续方案中有用。