Continued Use of Effective Contraception After Use of Emergency Contraception

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Helena Kopp Kallner, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02078414
First received: March 3, 2014
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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).


Condition
Emergency Contraception
Contraception
Reproductive Health

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Use of an effective contraceptive method [ Time Frame: 6 months after emergency contraceptive use ] [ Designated as safety issue: No ]
    Use of pill, patch, ring, IUD, IUS, or injection 6 months after use of emergency contraceptive method


Estimated Enrollment: 70
Study Start Date: March 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ulipristal acetate
Women choosing EllaOne as emergency contraception
Copper IUD
Women choosing copper IUD as emergency contraception

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078414

Contacts
Contact: Helena Kopp Kallner, MD, PhD helena.kopp-kallner@ki.se

Locations
Sweden
RFSU clinic Recruiting
Stockholm, Sweden
Contact: Helena Kopp Kallner, MD, PhD       helena.kopp-kallner@ki.se   
Principal Investigator: Helena Kopp Kallner         
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Helena Kopp Kallner, Consultant Obstetrics and Gynecology, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02078414     History of Changes
Other Study ID Numbers: RFSU1
Study First Received: March 3, 2014
Last Updated: March 31, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014