Intrauterine Contraception (IUC) After Medical Abortion

February 22, 2012 updated by: Kristina Gemzell Danielsson, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

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

  • Sweden
      • Stockholm, Sweden, 17176
        • WHO centre, Karolinska University Hospital

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 to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Women were free to chose the type of IUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expulsion
Time Frame: 6 months after IUC insertion
Expulsions are recorded up to 6 months after the IUC insertion
6 months after IUC insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PID
Time Frame: within 6 months of IUC insertion
Pelvic inflammatory disease reported or diagnosed at FU
within 6 months of IUC insertion
serum hemoglobin
Time Frame: 4 weeks post IUC insertion
S-Hb was measured at IUC insertion and at 4 weeks post insertion
4 weeks post IUC 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
6 months
Bleeding patterns
Time Frame: 4 weeks
Bleeding patterns during the first 4 weeks post IUC insertion
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2007

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (ESTIMATE)

February 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WIUC12

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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