- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884403
Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks
May 1, 2018 updated by: Wendy Norman, University of British Columbia
Several large trials report gestational dating by last menstrual period (LMP) overestimates gestational age (GA) vs. ultrasound (US) by approximately one week.
Previous studies examined only term pregnancies.
The investigators hypothesize an opposite tendency in women seeking abortion.
This is an observational study undertaken by chart review.
Study Overview
Status
Terminated
Conditions
Detailed Description
Retrospective cohort study by chart review.
We propose to review the charts of four thousand women obtaining abortion in British Columbia, BC.
Data will be extracted from the charts of women who obtained abortions between January first 2002 and June 30, 2008 inclusive at two abortion clinics in Vancouver, British Columbia: BC Women's Hospital CARE program, and the Elizabeth Bagshaw Women's Clinic.
Specifically we will record age, parity, date of LMP, presence of regular cycles, ultrasound estimation of gestational age, ultrasound measurements: crown rump length, bi-parietal diameter, gestational sac diameter if available, date of abortion, estimation of gestational age by examination of the products of conception, and fetal foot length if available.
Further we will record associated factors such as contraception at time of conception, intravenous drug use, and regularity of menstrual cycle.
We will calculate the gestational age at time of abortion by the LMP date, by the ultrasound date reported, ultrasound date based on the Hadlock protocol by the reported CRL and similarly BPD as well as calculating the gestational age based on the recorded fetal foot length.
Study Type
Observational
Enrollment (Actual)
415
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- BC Women's Hospital CARE Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
women in British Columbia who obtained abortion up to twenty weeks gestational age.
Description
Inclusion Criteria:
- Included charts of women who obtained abortion up to twenty weeks gestational age must have a stated LMP date, a pre-operative ultrasound, a viable pregnancy at the time of the abortion and an assessment of the gestational age of the products of conception.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference between actual gestational age assessed by pre-operative ultrasound and gestational age estimated by menstrual dating
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of the difference between AGA and LMP dating with demographic and obstetrical history factors.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendy V. Norman, MD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
April 3, 2009
First Submitted That Met QC Criteria
April 17, 2009
First Posted (ESTIMATE)
April 20, 2009
Study Record Updates
Last Update Posted (ACTUAL)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- H08-01332
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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