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

History of Changes

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:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

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 May 19, 2013

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