Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-04 @ 2:26 AM
Study NCT ID:
NCT00614432
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2008-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Sponsor:
University of Hawaii
Organization:
Study Overview
Official Title:
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: