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Intrauterine Contraception (IUC) After Medical Abortion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01537562
First received: February 15, 2012
Last updated: February 22, 2012
Last verified: February 2012

February 15, 2012
February 22, 2012
February 2007
April 2010   (final data collection date for primary outcome measure)
Expulsion [ Time Frame: 6 months after IUC insertion ] [ Designated as safety issue: Yes ]
Expulsions are recorded up to 6 months after the IUC insertion
Same as current
Complete list of historical versions of study NCT01537562 on ClinicalTrials.gov Archive Site
  • PID [ Time Frame: within 6 months of IUC insertion ] [ Designated as safety issue: Yes ]
    Pelvic inflammatory disease reported or diagnosed at FU
  • serum hemoglobin [ Time Frame: 4 weeks post IUC insertion ] [ Designated as safety issue: Yes ]
    S-Hb was measured at IUC insertion and at 4 weeks post insertion
  • Compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Bleeding patterns during the first 4 weeks post IUC insertion
Same as current
Not Provided
Not Provided
 
Intrauterine Contraception (IUC) After Medical Abortion
Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
IUC Insertion After Medical Abortion
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: Delayed IUC insertion
    Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment
    Intervention: Other: Timing of IUC insertion
  • Active Comparator: Early IUC insertion
    Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment.
    Intervention: Other: Timing of IUC insertion
Sääv I, Stephansson O, Gemzell-Danielsson K. Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial. PLoS One. 2012;7(11):e48948. doi: 10.1371/journal.pone.0048948. Epub 2012 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
October 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01537562
WIUC12
Yes
Kristina Gemzell Danielsson, Karolinska Institutet
Karolinska Institutet
Not Provided
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
Karolinska Institutet
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP