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

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ClinicalTrials.gov Identifier: NCT01223521
Recruitment Status : Active, not recruiting
First Posted : October 19, 2010
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
City of Helsinki
Information provided by (Responsible Party):
Elina Pohjoranta, Helsinki University Central Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Device: Immediate intrauterine contraception Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : September 2010
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Number of repeat abortions [ Time Frame: 5 years ]
    Number of subsequent abortions during five years follow-up time.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223521


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