Intrauterine Contraception (IUC) After Medical Abortion

NCT ID: NCT01537562

Last Updated: 2012-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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IUC Insertion After Medical Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Delayed IUC insertion

Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment

Group Type ACTIVE_COMPARATOR

Timing of IUC insertion

Intervention Type OTHER

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.

Early IUC insertion

Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment.

Group Type ACTIVE_COMPARATOR

Timing of IUC insertion

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Women were free to chose the type of IUC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Kristina Gemzell Danielsson

Professor, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristina Gemzell Danielsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

WHO centre, Dept of Women's and Childrens' Health, Div of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska Univeristy Hospital

Locations

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WHO centre, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Saav 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.

Reference Type DERIVED
PMID: 23155432 (View on PubMed)

Other Identifiers

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WIUC12

Identifier Type: -

Identifier Source: org_study_id

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