- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755715
Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy
March 4, 2019 updated by: Riina Korjamo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
264
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Helsinki, Finland
- Helsinki University Central Hospital, Dept Ob&Gyn
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Insertion of IUD at 2-4 weeks after abortion.
|
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Experimental: Immediate IUD insertion
Insertion of IUD immediately (at the same day to 3 days) after expulsion of placenta.
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Insertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of expulsions
Time Frame: 1 year
|
Number of IUD expulsions
|
1 year
|
Use of IUD
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bleeding profile
Time Frame: 3 months
|
3 months
|
Repeat abortions
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Oskari Heikinheimo, MD, PhD, Helsinki University Central Hospital
- Principal Investigator: Maarit Mentula, MD, PhD, Helsinki University Central Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
December 13, 2012
First Submitted That Met QC Criteria
December 19, 2012
First Posted (Estimate)
December 24, 2012
Study Record Updates
Last Update Posted (Actual)
March 7, 2019
Last Update Submitted That Met QC Criteria
March 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- KILKE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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