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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 Karolinska Institutet:

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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Karolinska Institutet

Additional 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
Study First Received: February 15, 2012
Last Updated: February 22, 2012
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on October 23, 2014