Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.

NCT ID: NCT01223521

Last Updated: 2018-08-24

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

748 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Immediate intrauterine contraception

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

Group Type EXPERIMENTAL

Immediate intrauterine contraception

Intervention Type DEVICE

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immediate intrauterine contraception

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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City of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elina Pohjoranta

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oskari Heikinheimo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Satu P Suhonen, MD, PhD

Role: STUDY_DIRECTOR

City of Helsinki

Locations

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Dept Obstetrics and Gynecology, Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 26370664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27500660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27836586 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32266392 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30219793 (View on PubMed)

Other Identifiers

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TYH2010224

Identifier Type: -

Identifier Source: org_study_id

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