Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.

This study is currently recruiting participants.
Verified July 2010 by Helsinki University Central Hospital
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01223521
First received: October 18, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and life quality.


Condition Intervention
Contraception After First Trimester Abortion.
Device: Post-abortal provision of intrauterine device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Number of repeat abortions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expulsions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate intrauterine contraception
IUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion.
Device: Post-abortal provision of intrauterine device
A Cu-IUD or LNG-IUS is inserted after abortion.
No Intervention: Control group
Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Duration of pregnancy < 12 weeks.
  • Age ≥18 years

Exclusion Criteria:

  • Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223521

Contacts
Contact: Oskari Heikinheimo, MD, PhD +358 40 5871070 oskari.heikinheimo@helsinki.fi
Contact: Satu P. Suhonen, MD, PhD +358 50 4025591 satu.suhonen@hel.fi

Locations
Finland
Dept Obstetrics and Gynecology, Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029 HUS
Contact: Oskari Heikinheimo, MD, PhD    +358 40 5871070    oskari.heikinheimo@helsinki.fi   
Contact: Pirjo Ikonen    +358 50 4279734    pirjo.h.ikonen@hus.fi   
Sub-Investigator: Maarit Mentula, MD         
Sub-Investigator: Elina Pohjoranta, MD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Oskari Heikinheimo, MD, PhD Helsinki University Central Hospital
Study Director: Satu P Suhonen, MD, PhD City of Helsinki
  More Information

No publications provided

Responsible Party: Oskari Heikinheimo, physician in-chief, Helsinki University Central Hospital, Dept Ob&Gyn
ClinicalTrials.gov Identifier: NCT01223521     History of Changes
Other Study ID Numbers: TYH2010224
Study First Received: October 18, 2010
Last Updated: October 18, 2010
Health Authority: Finland: Helsinki University Central Hospital

Keywords provided by Helsinki University Central Hospital:
Contraception
Abortion
First trimester
Intrauterine device

ClinicalTrials.gov processed this record on April 14, 2014