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Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy

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ClinicalTrials.gov Identifier: NCT01755715
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Riina Korjamo, Helsinki University Central Hospital

Brief Summary:
The main objective of this study is to compare, in a randomised, controlled and prospective fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days) versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception one year after abortion.

Condition or disease Intervention/treatment Phase
Contraception After Medical Abortion Procedure: Immediate IUD insertion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
No Intervention: Control group
Insertion of IUD at 2-4 weeks after abortion.
Experimental: Immediate IUD insertion
Insertion of IUD immediately (at the same day to 3 days) after expulsion of placenta.
Procedure: Immediate IUD insertion
Insertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta.



Primary Outcome Measures :
  1. Number of expulsions [ Time Frame: 1 year ]
    Number of IUD expulsions

  2. Use of IUD [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Bleeding profile [ Time Frame: 3 months ]
  2. Repeat abortions [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Planning medical abortion
  • Planning LNG-IUD (Mirena) contraception

Exclusion Criteria:

  • Pathological pregnancies or abnormality of the uterus or cervix
  • Acute endometritis

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): NCT01755715


Locations
Finland
Helsinki University Central Hospital, Dept Ob&Gyn
Helsinki, Finland
Sponsors and Collaborators
Riina Korjamo
Investigators
Study Director: Oskari Heikinheimo, MD, PhD Helsinki University Central Hospital
Principal Investigator: Maarit Mentula, MD, PhD Helsinki University Central Hospital

Responsible Party: Riina Korjamo, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01755715     History of Changes
Other Study ID Numbers: KILKE
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Riina Korjamo, Helsinki University Central Hospital:
Abortion
Contraception
Intrauterine Devices
Intrauterine Device Expulsion