AbortionNCT00884403
Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks
An observational study of Abortion, run by University of British Columbia at 1 site in Canada.
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. 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
- Abortion
- How many people
- 415 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Jun 2009
- 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: women in British Columbia who obtained abortion up to twenty weeks gestational age.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Abortion
- Keywords
- abortion, pregnancy dating, gestational age, ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between actual gestational age assessed by pre-operative ultrasound and gestational age estimated by menstrual dating
Measured: 1 year
Secondary outcomes (1)
Correlation of the difference between AGA and LMP dating with demographic and obstetrical history factors.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: This study is a retrospective chart review study, not a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Responsible party
- Principal investigator, Wendy Norman, University of British Columbia
- Investigators
- Wendy V. Norman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884403
- Sponsor's protocol ID
- H08-01332
- Status last verified
- May 2018
- First submitted
- 3 Apr 2009
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21453565
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks
- ClinicalTrials.gov ID
- NCT00884403
- Acronym / sponsor ID
- H08-01332
- Conditions
- Abortion
- Keywords
- abortion, pregnancy dating, gestational age, ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study is a retrospective chart review study, not a clinical trial.
- Enrolment
- 415 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Apr 2009 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women in British Columbia who obtained abortion up to twenty weeks gestational age.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
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
Difference between actual gestational age assessed by pre-operative ultrasound and gestational age estimated by menstrual dating
Time frame: 1 year
1 secondary outcome
Correlation of the difference between AGA and LMP dating with demographic and obstetrical history factors.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: This study is a retrospective chart review study, not a clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Results publication: PubMed 21453565Norman 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.
Related trials for Abortion
Recruiting
Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
Unexplained Pregnancy Loss
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
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.
Wendy V. Norman, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: This study is a retrospective chart review study, not a clinical trial.). Results are not available in the source record.
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?
Difference between actual gestational age assessed by pre-operative ultrasound and gestational age estimated by menstrual dating (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884403, which also lists 1 linked publication.
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 4 May 2018.