The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women

NCT ID: NCT01685164

Last Updated: 2018-02-23

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

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

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As intrauterine contraception is an increasingly popular form of contraception the objective of our study is to examine if uterine size or posture affects the insertion or use of intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.

Detailed Description

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Prospective observational study among nulliparous women requesting intrauterine contraception.

Conditions

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Intrauterine Contraception

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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LNG-IUS

Nulliparous women

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Intervention Type OTHER

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Cu-IUD

Nulliparous women

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Intervention Type OTHER

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Interventions

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Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- nulliparous women with no previous history of IUD use

Exclusion Criteria

* malformation of uterus
* myomas
* acute gynecological infection
* malignant uterine or cervical tumor

In addition if requesting a Cu-IUD

* heavy menstruations
* iron deficiency
* bleeding disorder
* copper allergy or Wilson's disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Satu P. Suhonen, MD, PhD

Physician in chief, Centralized Family Planning, City of Helsinki Health Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Contraceptive unit of city of Helsinki

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Kaislasuo J, Heikinheimo O, Lahteenmaki P, Suhonen S. Menstrual characteristics and ultrasonographic uterine cavity measurements predict bleeding and pain in nulligravid women using intrauterine contraception. Hum Reprod. 2015 Jul;30(7):1580-8. doi: 10.1093/humrep/dev102. Epub 2015 May 19.

Reference Type DERIVED
PMID: 25990577 (View on PubMed)

Kaislasuo J, Heikinheimo O, Lahteenmaki P, Suhonen S. Predicting painful or difficult intrauterine device insertion in nulligravid women. Obstet Gynecol. 2014 Aug;124(2 Pt 1):345-353. doi: 10.1097/AOG.0000000000000362.

Reference Type DERIVED
PMID: 25004340 (View on PubMed)

Other Identifiers

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1491/13/03/03/2010

Identifier Type: -

Identifier Source: org_study_id

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