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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 15, 2012

Last Updated Date

February 22, 2012

Start Date ^ICMJE

February 2007

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Expulsion [ Time Frame: 6 months after IUC insertion ] [ Designated as safety issue: Yes ]

Expulsions are recorded up to 6 months after the IUC insertion

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01537562 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intrauterine Contraception (IUC) After Medical Abortion

Official Title ^ICMJE

Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

IUC Insertion After Medical Abortion

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

129

Completion Date

October 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01537562

Other Study ID Numbers ^ICMJE

WIUC12

Has Data Monitoring Committee

Yes

Responsible Party

Kristina Gemzell Danielsson, Karolinska Institutet

Study Sponsor ^ICMJE

Karolinska Institutet

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Karolinska Institutet

Verification Date

February 2012

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

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