Post Abortion IUD & Recurrent Abortion 2005-2006 | NCT01776957

Studies
Post Abortion IUD & Recurrent Abortion 2005-2006

NCT01776957

Sponsor

University of British Columbia

Status

Terminated

Last Update Posted

May 4, 2018Actual

Enrollment

1,308Actual

Phase

Not provided

Conditions

Induced Abortion

Interventions

Device: Intrauterine device (IUD)

Countries

Not provided

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 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study is a retrospective chart review study, not a clinical trial.

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 21, 2013

First Submission Date that Met QC Criteria

Jan 23, 2013

First Posted Date

Jan 28, 2013Estimated

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 1, 2018

Last Update Posted Date

May 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wendy Norman, Principle Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

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 rate of repeat abortions will be lowest in those women who choose immediate insertion of an IUD post-abortion versus those who immediately choose oral contraceptive pills and those who indicate all other contraceptive choices including no contraception The provision by the health system of IUDs for immediate insertion will result in the lowest health system costs.

Detailed Description

The investigators intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion. Thus, if providing a free IUD immediately post-abortion significantly reduces the rate of repeat abortions, it may be more cost- effective for health system services to provide free IUDs at abortion clinics than to field the costs associated with a higher rate of repeat abortions.

The researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of women undergoing abortions between January 1, 2005 and December 31, 2006 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IUD		Repeat abortion rate in women receiving IUDs immediately post-abortion	Device: Device: Intrauterine device (IUD)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device: Intrauterine device (IUD)	Device	Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion	IUD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of repeat abortions at five years from the index abortions		5 years

Secondary Outcomes

Measure	Description	Time Frame
Correlation of repeat and index abortions with obstetrical, demographic and contraceptive history factors.		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female resident of Interior Health region seeking an abortion between January 1, 2005 and December 31, 2006

Exclusion Criteria:

Women undergoing abortions for fetal genetic abnormalities

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female resident of Interior Health region seeking an abortion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wendy Norman, Dr.	University of British Columbia	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007434	Intrauterine Devices

Ancestor Terms

ID	Term
D003274	Contraceptive Devices, Female
D003273	Contraceptive Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided