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临床试验/NCT02763176
NCT02763176已完成不适用

Measuring hCG Levels in Pregnant Women: a Prenatal Study of hCG Using MLPT and Serum Testing

Gynuity Health Projects0 个研究点目标入组 150 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
主要终点
hCG trends

研究概览

简要总结

This study seeks to assess trends in hCG between the 9th and 12th weeks of gestation. Women presenting at prenatal care at the study site who are 70 days gestation or less will be offered participation in the study. 75 consenting women will be asked to provide urine for an MLPT and to have blood drawn for hCG serum testing at 56-63 days, 64-70 days, and 71-77 days' gestation, and 75 consenting women will be asked to provide urine for an MLPT and to have blood drawn for hCG serum testing at 64-70 days, 71-77 days, and 78-84 days' gestation.

详细描述

Women presenting at the study site for a prenatal visit, and who are ≤ 70 days' gestation, will be offered participation in the study. Efforts will also be made to recruit patients through physician or treating health care professional referral and advertisements. One hundred and fifty consenting women will be enrolled. Up to three additional study visits will be scheduled: At the enrollment, if an ultrasound-confirmed gestational age is not available in the woman's medical record, a transvaginal ultrasound will be performed. If the woman is 56-63 days gestation on the day of enrollment, she will be asked to return weekly until she reaches 71-77 days. If the woman is 64-70 days gestation, she will be asked to return weekly until she reaches 78-84 days. If the woman is less than 56 days gestation, she will be asked to return for the three research visits at the appropriate time to provide the urine samples and blood draws. Women will have one visit during each of their three assigned gestational age weeks. At each visit, women will provide a urine sample for an MLPT and have a blood draw to measure serum hCG.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Intrauterine pregnancy <= 70 days' gestation
  • Be in general good health
  • English speaking competency
  • Be willing and able to sign consent forms
  • Agree to comply with the study procedures, including returning for three study visits that each involve a blood draw and urine pregnancy test for measuring hCG

排除标准

  • Women less than 18 years of age.
  • Any women not meeting the inclusion criteria listed above will be excluded from participating in the trial.

结局指标

主要结局

hCG trends

时间窗: Between 56-84 days gestation

To ascertain the proportion of women with decreases in hCG between 56-84 days gestation

次要结局

未报告次要终点

研究者

发起方
Gynuity Health Projects
申办方类型
Other
责任方
Sponsor

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