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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00884403
Other study ID # H08-01332
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2008
Est. completion date June 2009

Study information

Verified date May 2018
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 415
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada BC Women's Hospital CARE Program Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Women's Health Research Institute of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Norman WV, Bergunder J, Eccles L. Accuracy of gestational age estimated by menstrual dating in women seeking abortion beyond nine weeks. J Obstet Gynaecol Can. 2011 Mar;33(3):252-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between actual gestational age assessed by pre-operative ultrasound and gestational age estimated by menstrual dating 1 year
Secondary Correlation of the difference between AGA and LMP dating with demographic and obstetrical history factors. 1 year
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