Blood LossNCT00614432
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
An observational study of Blood Loss, run by University of Hawaii at 2 sites in United States.
Trial summary
The primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Apr 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment.
Who may be able to join
- Female seeking abortion services
- Less than or equal to 12 weeks gestation
- Age 18-50
- Willing and able to sign informed consent
- Use of Coumadin or LMW heparin (treatment group only)
Who cannot join
- Unwilling or unable to sign informed consent
- Women taking daily aspirin or herbal therapies containing gingko biloba
- Women with a known history of a bleeding disorder such as von willebrand's disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Hawaii
Honolulu, Hawaii, 96822
Oregon Health and Science University
Portland, Oregon, 97239
About this study
The primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. This study is based on the hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women receiving surgical abortions up to 12 weeks gestation.
Read the detailed description
We intend to conduct a prospective cohort study at Oregon Health and Science University and the University of Hawaii. This study will not be blinded and subjects will not be randomized. Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. For patients who are receiving anticoagulant medications, the decision to continue anticoagulant therapy or interrupt it will be made by the patient's physician, independently of this study.
We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment. This is a matched study and our control group will be matched for gestational age, parity, and cesarean section history.
- Conditions
- Blood Loss
- Keywords
- anticoagulation, surgical abortion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women who are anticoagulated. | |
| 2 | Matched case controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Intraoperative Blood Loss
Quantitative blood loss using volume measurement and weight
Measured: Post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood LossStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Bliss Kaneshiro, University of Hawaii
- Investigators
- Bliss Kaneshiro, M.D., Principal investigator, University of HawaiiAlison Edelman, M.D., M.P.H., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614432
- Sponsor's protocol ID
- OHSU FAMPLAN 3861
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2008
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
- ClinicalTrials.gov ID
- NCT00614432
- Acronym / sponsor ID
- OHSU FAMPLAN 3861
- Conditions
- Blood Loss
- Keywords
- anticoagulation, surgical abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. This study is based on the hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women receiving surgical abortions up to 12 weeks gestation.
Detailed description
We intend to conduct a prospective cohort study at Oregon Health and Science University and the University of Hawaii. This study will not be blinded and subjects will not be randomized. Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. For patients who are receiving anticoagulant medications, the decision to continue anticoagulant therapy or interrupt it will be made by the patient's physician, independently of this study.
We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment. This is a matched study and our control group will be matched for gestational age, parity, and cesarean section history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women who are anticoagulated. |
| 2 | – | –Matched case controls. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. Our control group will consist of women who are not on anticoagulant treatment.
Key inclusion criteria (5 listed)
- Female seeking abortion services
- Less than or equal to 12 weeks gestation
- Age 18-50
- Willing and able to sign informed consent
- Use of Coumadin or LMW heparin (treatment group only)
Key exclusion criteria (3 listed)
- Unwilling or unable to sign informed consent
- Women taking daily aspirin or herbal therapies containing gingko biloba
- Women with a known history of a bleeding disorder such as von willebrand's disease
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
Volume of Intraoperative Blood Loss
Time frame: Post procedure
Quantitative blood loss using volume measurement and weight
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bliss Kaneshiro, M.D. principal investigator
University of Hawaii
Alison Edelman, M.D., M.P.H. principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, run by University of Hawaii at 2 sites in United States.
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 3 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Volume of Intraoperative Blood Loss (time frame: Post procedure). 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 18 Jul 2022.