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Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elina Kuronen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01223521
First received: October 18, 2010
Last updated: August 22, 2016
Last verified: August 2016
  Purpose
A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.

Condition Intervention
Contraception
Device: Immediate intrauterine contraception

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Number of repeat abortions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expulsions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: September 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate intrauterine contraception
IUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion.
Device: Immediate intrauterine contraception
A Cu-IUD or LNG-IUS is inserted after abortion.
No Intervention: Control group
Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Duration of pregnancy < 12 weeks.
  • Age ≥18 years

Exclusion Criteria:

  • Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).
  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: NCT01223521

Locations
Finland
Dept Obstetrics and Gynecology, Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Oskari Heikinheimo, MD, PhD Helsinki University Central Hospital
Study Director: Satu P Suhonen, MD, PhD City of Helsinki
  More Information

Responsible Party: Elina Kuronen, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01223521     History of Changes
Other Study ID Numbers: TYH2010224 
Study First Received: October 18, 2010
Last Updated: August 22, 2016
Health Authority: Finland: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Helsinki University Central Hospital:
Contraception
Abortion
First trimester
Intrauterine device

ClinicalTrials.gov processed this record on September 26, 2016