NCT01223521

Brief Summary

A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
748

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

7.5 years

First QC Date

October 18, 2010

Last Update Submit

August 23, 2018

Conditions

Contraception

Keywords

ContraceptionAbortionFirst trimesterIntrauterine device

Outcome Measures

Primary Outcomes (1)

  • Number of repeat abortions

    Number of subsequent abortions during five years follow-up time.

    5 years

Study Arms (2)

Immediate intrauterine contraception

EXPERIMENTAL

IUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion.

Device: Immediate intrauterine contraception

Control group

NO INTERVENTION

Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient.

Interventions

Immediate intrauterine contraceptionDEVICE

A Cu-IUD or LNG-IUS is inserted after abortion.

Immediate intrauterine contraception

Eligibility Criteria

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

You may qualify if:

  • Duration of pregnancy \< 12 weeks.
  • Age ≥18 years

You may not qualify if:

  • Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Obstetrics and Gynecology, Helsinki University Central Hospital

Helsinki, 00029 HUS, Finland

Location

Related Publications (5)

  • Pohjoranta E, Mentula M, Gissler M, Suhonen S, Heikinheimo O. Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial. Hum Reprod. 2015 Nov;30(11):2539-46. doi: 10.1093/humrep/dev233. Epub 2015 Sep 14.

    PMID: 26370664BACKGROUND

  • Toffol E, Pohjoranta E, Suhonen S, Hurskainen R, Partonen T, Mentula M, Heikinheimo O. Anxiety and quality of life after first-trimester termination of pregnancy: a prospective study. Acta Obstet Gynecol Scand. 2016 Oct;95(10):1171-80. doi: 10.1111/aogs.12959.

    PMID: 27500660BACKGROUND

  • Pohjoranta E, Suhonen S, Mentula M, Heikinheimo O. Intrauterine contraception after medical abortion: factors affecting success of early insertion. Contraception. 2017 Mar;95(3):257-262. doi: 10.1016/j.contraception.2016.10.012. Epub 2016 Nov 9.

    PMID: 27836586BACKGROUND

  • Pohjoranta E, Suhonen S, Gissler M, Ikonen P, Mentula M, Heikinheimo O. Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial. Hum Reprod. 2020 Apr 28;35(4):796-804. doi: 10.1093/humrep/deaa031.

    PMID: 32266392DERIVED

  • Pohjoranta E, Mentula M, Suhonen SP, Heikinheimo O. Predicting poor compliance with follow-up and intrauterine contraception services after medical termination of pregnancy. BMJ Sex Reprod Health. 2018 Sep 15:bmjsrh-2018-200098. doi: 10.1136/bmjsrh-2018-200098. Online ahead of print.

    PMID: 30219793DERIVED

Study Officials

  • Oskari Heikinheimo, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

  • Satu P Suhonen, MD, PhD

    City of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)