Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy

This study is currently recruiting participants.
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
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 April 15, 2014