hCGNCT02763176
Measuring hCG Levels in Pregnant Women
An observational study of hCG, run by Gynuity Health Projects.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- hCG
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women seeking prenatal care.
Who may be able to join
- 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
Who cannot join
- Women less than 18 years of age.
- Any women not meeting the inclusion criteria listed above will be excluded from participating in the trial.
About this study
Official title: Measuring hCG Levels in Pregnant Women: a Prenatal Study of hCG Using MLPT and Serum Testing
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.
Read the detailed description
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.
- Conditions
- hCG
- Keywords
- hCG testing, multi-level pregnancy test
What is being measured
The primary outcome is the main question the study is designed to answer.
hCG trends
To ascertain the proportion of women with decreases in hCG between 56-84 days gestation
Measured: Between 56-84 days gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for hCGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763176
- Sponsor's protocol ID
- 6007
- Status last verified
- Jun 2018
- First submitted
- 3 May 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring hCG Levels in Pregnant Women: a Prenatal Study of hCG Using MLPT and Serum Testing
- ClinicalTrials.gov ID
- NCT02763176
- Acronym / sponsor ID
- 6007
- Conditions
- hCG
- Keywords
- hCG testing, multi-level pregnancy test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women seeking prenatal care.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Women less than 18 years of age.
- Any women not meeting the inclusion criteria listed above will be excluded from participating in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hCG trends
Time frame: Between 56-84 days gestation
To ascertain the proportion of women with decreases in hCG between 56-84 days gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of hCG, run by Gynuity Health Projects.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hCG trends (time frame: Between 56-84 days gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.