- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00907725
Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?
Follow-up With Serum BhCG Simplify Medical Abortion: A Randomized Controlled Trial
The purpose of this study is to evaluate if BhCG testing to determine the completion of medical abortion simplifies the medical abortion protocol. Investigators hypothesize that women randomized to ultrasonographic determination of completion of medical abortion will have MORE follow-up visits/interventions beyond standard protocol than those randomized to medical abortion follow-up with serum BhCG.
The investigators also hope to explore satisfaction with BhCG based follow-up among women seeking medical abortion. Investigators hypothesize that the majority of women who choose to follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Planned Parenthood League of Massachusetts
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women undergoing medical abortion
- Proficiency in English
- Working phone and willingness to be contacted by phone
- Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with chosen follow-up method
Exclusion Criteria:
- Concern for ectopic pregnancy or unable to document intrauterine pregnancy
- Clinical instability or signs of pelvic infection
- Medical conditions that contraindicate medical abortion
- Unwilling or unable to comply with study follow-up procedures
- Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g., situations of domestic violence)
- Inability to give informed consent
- Previous participation in this study
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 1
serum BhCG follow-up
|
Subjects in this arm will receive medical abortion follow-up using BhCG blood draw
|
OTHER: 2
ultrasonographic follow-up
|
Subjects in this arm will receive medical abortion follow-up by ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient satisfaction with follow-up method
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Principal Investigator, Planned Parenthood
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2009p000363
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Medical Abortion
-
Gynuity Health ProjectsCompletedMedical AbortionArmenia, Georgia, Kazakhstan
-
Gynuity Health ProjectsCompletedMedical AbortionUnited States, Vietnam, Georgia, Azerbaijan, Mexico
-
Gynuity Health ProjectsStanford University; Secretaría de Salud del Distrito Federal; Office National... and other collaboratorsCompletedMedical AbortionUnited States, Mexico, Tunisia, Vietnam
-
Karolinska InstitutetUllevaal University Hospital; University of Helsinki; Gynmed Clinic ViennaCompletedMedical AbortionSweden, Austria, Finland, Norway
-
World Health OrganizationCenter for Research and Environmental Health and Population Activities (CREHPA)Completed
-
Gynuity Health ProjectsPlanned Parenthood Federation of America; David and Lucile Packard FoundationCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedMedical; Abortion, Fetus | Second Trimester AbortionTurkey
-
Stanford UniversityCompleted
-
Gynuity Health ProjectsCompleted
-
Gynuity Health ProjectsFamily Planning Association PakistanCompleted
Clinical Trials on serum BhCG follow-up
-
Hospices Civils de LyonTerminatedPeriprosthetic Joint Infection (PJI) | Bone and Join Infection (BJI)France
-
Istanbul University - Cerrahpasa (IUC)CompletedInfertility | Psychological Distress | Infertility, Female | Depression, Anxiety | Nurse's RoleTurkey
-
Women's College HospitalCompletedMedical; Abortion, FetusCanada
-
M.D. Anderson Cancer CenterRecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Sport Injury Prevention Research CentreGeneral Electric; National Basketball AssociationCompletedTendinopathy | Sports Injuries in Children | Injury, Knee | Injury, AnkleCanada
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
Centre Hospitalier Universitaire, AmiensRecruitingQuality of Life | Pain | Lumbar Spine SurgeryFrance
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Trialbureau... and other collaboratorsRecruitingAdolescent Idiopathic ScoliosisNetherlands
-
University of IcelandMemorial Sloan Kettering Cancer Center; Landspitali University Hospital; deCODE... and other collaboratorsActive, not recruitingMonoclonal Gammopathy of Undetermined SignificanceIceland
-
Rennes University HospitalUnknown