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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01223521
Recruitment Status : Active, not recruiting
First Posted : October 19, 2010
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Contraception Device: Immediate intrauterine contraception

Study Design

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

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Number of repeat abortions [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Expulsions [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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).
Contacts and Locations

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
Investigators
Principal Investigator: Oskari Heikinheimo, MD, PhD Helsinki University Central Hospital
Study Director: Satu P Suhonen, MD, PhD City of Helsinki
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elina Kuronen, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01223521     History of Changes
Other Study ID Numbers: TYH2010224
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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