Continued Use of Effective Contraception After Use of Eme... | NCT02078414

Studies
Continued Use of Effective Contraception After Use of Emergency Contraception

NCT02078414

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Emergency Contraception
Contraception
Reproductive Health

Interventions

Not provided

Countries

Sweden

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

Nov 2023

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

Mar 2014

Primary Completion Date

Feb 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Mar 3, 2014

First Submission Date that Met QC Criteria

Mar 4, 2014

First Posted Date

Mar 5, 2014Estimated

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

Nov 28, 2023

Last Update Posted Date

Nov 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helena Kopp Kallner, Consultant Obstetrics and Gynecology, PhD, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Not provided

Description Module

Brief Summary

Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ulipristal acetate		Women choosing EllaOne as emergency contraception
Copper IUD		Women choosing copper IUD as emergency contraception

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Use of an effective contraceptive method	Use of pill, patch, ring, IUD, IUS, or injection 6 months after use of emergency contraceptive method	6 months after emergency contraceptive use

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women over 18 years
eligible for all emergency contraception

Exclusion Criteria:

previous conisation
known stenosis of the cervix
signs of ongoing genital infection
known uterine anomaly
Known bleeding disorder

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women without contraception or with a failed contraceptive method seeking emergency contraception

Sampling Method

Non-Probability Sample