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Intrauterine Contraception (IUC) After Medical Abortion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537562
First Posted: February 23, 2012
Last Update Posted: February 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
  Purpose
Today a large proportion of early abortions are medical, in accordance to the woman's choice. The main objective of the present study was to compare, in a randomised fashion, initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion with regard to expulsions and safety.

Condition Intervention
IUC Insertion After Medical Abortion Other: Timing of IUC insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kristina Gemzell Danielsson, Karolinska Institutet:

Primary Outcome Measures:
  • Expulsion [ Time Frame: 6 months after IUC insertion ]
    Expulsions are recorded up to 6 months after the IUC insertion


Secondary Outcome Measures:
  • PID [ Time Frame: within 6 months of IUC insertion ]
    Pelvic inflammatory disease reported or diagnosed at FU

  • serum hemoglobin [ Time Frame: 4 weeks post IUC insertion ]
    S-Hb was measured at IUC insertion and at 4 weeks post insertion

  • Compliance [ Time Frame: 6 months ]
    impact on the number of women who return for IUC insertion, and compliance with IUC use during the first 6 months following insertion

  • Bleeding patterns [ Time Frame: 4 weeks ]
    Bleeding patterns during the first 4 weeks post IUC insertion


Enrollment: 129
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delayed IUC insertion
Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment
Other: Timing of IUC insertion
Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone.
Other Name: Women were free to chose the type of IUC
Active Comparator: Early IUC insertion
Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment.
Other: Timing of IUC insertion
Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone.
Other Name: Women were free to chose the type of IUC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age above 18
  • elective medical abortion up to 9 weeks (63 days) of amenorrhea
  • general good health and
  • good understanding of Swedish language.

Exclusion Criteria:

  • pathological pregnancies or abnormality of the uterus
  • complications after the medical abortion, such as on-going pregnancy retained gestational sac or endometritis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537562


Locations
Sweden
WHO centre, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Kristina Gemzell Danielsson, MD, PhD WHO centre, Dept of Women's and Childrens' Health, Div of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska Univeristy Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, Professor, Head of Department, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01537562     History of Changes
Other Study ID Numbers: WIUC12
First Submitted: February 15, 2012
First Posted: February 23, 2012
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
Copper IUD
LNG-IUS
intrauterine contraception
medical abortion
postabortion contraception

Additional relevant MeSH terms:
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents