Does Follow-up With Serum Beta Human Chorionic Gonadotrop... | NCT00907725

Studies
Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?

NCT00907725

Sponsor

Planned Parenthood League of Massachusetts

Status

Completed

Last Update Posted

May 10, 2012Estimated

Enrollment

376Actual

Phase

Not Applicable

Conditions

Medical Abortion

Interventions

serum BhCG follow-up
ultrasonographic follow-up

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

May 22, 2009

First Submission Date that Met QC Criteria

May 22, 2009

First Posted Date

May 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2012

Last Update Posted Date

May 10, 2012Estimated

Name	Class
Society of Family Planning	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

376Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	serum BhCG follow-up	Other: serum BhCG follow-up
2	Other	ultrasonographic follow-up	Other: ultrasonographic follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum BhCG follow-up	Other	Subjects in this arm will receive medical abortion follow-up using BhCG blood draw	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Receipt of any additional intervention or follow-up beyond the one routinely scheduled follow-up ultrasound or follow-up BhCG draw		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction with follow-up method		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Principal Investigator	Planned Parenthood	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood League of Massachusetts		Boston	Massachusetts	02215	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23635625	Derived	Dayananda I, Maurer R, Fortin J, Goldberg AB. Medical abortion follow-up with serum human chorionic gonadotropin compared with ultrasonography: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):607-613. doi: 10.1097/AOG.0b013e3182839fda.