NCT01755715

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

5.9 years

First QC Date

December 13, 2012

Last Update Submit

March 4, 2019

Conditions

Contraception After Medical Abortion

Keywords

AbortionContraceptionIntrauterine DevicesIntrauterine Device Expulsion

Outcome Measures

Primary Outcomes (2)

  • Number of expulsions

    Number of IUD expulsions

    1 year

  • Use of IUD

    1 year

Secondary Outcomes (2)

  • Bleeding profile

    3 months

  • Repeat abortions

    5 years

Study Arms (2)

Control group

NO INTERVENTION

Insertion of IUD at 2-4 weeks after abortion.

Immediate IUD insertion

EXPERIMENTAL

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

Procedure: Immediate IUD insertion

Interventions

Immediate IUD insertionPROCEDURE

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

Immediate IUD insertion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pathological pregnancies or abnormality of the uterus or cervix
  • Acute endometritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Dept Ob&Gyn

Helsinki, Finland

Location

Study Officials

  • Oskari Heikinheimo, MD, PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Maarit Mentula, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 24, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

FI(1)