Measuring hCG Levels in Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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hCG

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Women less than 18 years of age. Any women not meeting the inclusion criteria listed above will be excluded from participating in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hCG trends | To ascertain the proportion of women with decreases in hCG between 56-84 days gestation | Between 56-84 days gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hCG testing, multi-level pregnancy test