NCT00884403

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

April 3, 2009

Last Update Submit

May 1, 2018

Conditions

Abortion

Keywords

abortionpregnancy datinggestational ageultrasound

Outcome Measures

Primary Outcomes (1)

  • Difference between actual gestational age assessed by pre-operative ultrasound and gestational age estimated by menstrual dating

    1 year

Secondary Outcomes (1)

  • Correlation of the difference between AGA and LMP dating with demographic and obstetrical history factors.

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women in British Columbia who obtained abortion up to twenty weeks gestational age.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital CARE Program

Vancouver, British Columbia, Canada

Location

Related 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. doi: 10.1016/s1701-2163(16)34826-5.

    PMID: 21453565RESULT

Study Officials

  • Wendy V. Norman, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 20, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

CA(1)