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OpenTrials
Completed

NCT Number: NCT02763176

Measuring hCG Levels in Pregnant Women

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.

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Key information

Conditions

hCG

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. hCG trends

    Time frame: Between 56-84 days gestation

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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2016
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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