Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy

NCT ID: NCT01755715

Last Updated: 2019-03-07

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

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-12-31

Brief Summary

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The main objective of this study is to compare, in a randomised, controlled and prospective fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days) versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception one year after abortion.

Detailed Description

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Conditions

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Contraception After Medical Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Insertion of IUD at 2-4 weeks after abortion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Immediate IUD insertion

Insertion of IUD immediately (at the same day to 3 days) after expulsion of placenta.

Group Type EXPERIMENTAL

Immediate IUD insertion

Intervention Type PROCEDURE

Insertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta.

Interventions

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Immediate IUD insertion

Insertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Planning medical abortion
* Planning LNG-IUD (Mirena) contraception

Exclusion Criteria

* Pathological pregnancies or abnormality of the uterus or cervix
* Acute endometritis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riina Korjamo

OTHER

Sponsor Role lead

Responsible Party

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Riina Korjamo

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Oskari Heikinheimo, MD, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Maarit Mentula, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital, Dept Ob&Gyn

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KILKE

Identifier Type: -

Identifier Source: org_study_id

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