Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Riina Korjamo, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01755715
First received: December 13, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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 Intervention
Contraception After Medical Abortion
Procedure: Immediate IUD insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Number of expulsions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of IUD expulsions

  • Use of IUD [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Repeat abortions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  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: NCT01755715

Contacts
Contact: Oskari Heikinheimo, MD, PhD +358 40 5871070 oskari.heikinheimo@helsinki.fi

Locations
Finland
Helsinki University Central Hospital, Dept Ob&Gyn Recruiting
Helsinki, Finland
Contact: Oskari Heikinheimo, MD, PhD    +358 40 5871070    oskari.heikinheimo@helsinki.fi   
Sub-Investigator: Riina Korjamo, MD         
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
  More Information

No publications provided

Responsible Party: Riina Korjamo, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01755715     History of Changes
Other Study ID Numbers: KILKE
Study First Received: December 13, 2012
Last Updated: January 30, 2013
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on August 01, 2014