Evidence map›Paper›PMID 35865736›Full record

ArticleEClinicalMedicine2022

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

David Hubacher, Courtney A Schreiber, David K Turok, Jeffrey T Jensen, Mitchell D Creinin, Kavita Nanda, Katharine O'Connell White, Ila Dayananda, Stephanie B Teal, Pai-Lien Chen and 12 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03124160 (A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03124160 phase3completednot on this map

A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard

TypeinterventionalSponsorFHI 360Ran2017 to 2022Enrolled1,105ConditionsHealthy Women, Female ContraceptionArmsMona Lisa® NT Cu380 Mini, ParaGard® TCu380A
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 17 institutions in 1 country.

David HubacherFHI 360, Durham, NC, USA.
Courtney A SchreiberDepartment of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.
David K TurokDepartment of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USA.
Jeffrey T JensenDepartment of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR, USA.
Mitchell D CreininDepartment of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.
Kavita NandaFHI 360, Durham, NC, USA.
Katharine O'Connell WhiteDepartment of Obstetrics and Gynecology, Boston University, Boston, MA, USA.
Ila DayanandaPlanned Parenthood Greater New York, New York, NY, USA.
Stephanie B TealDepartment of Obstetrics and Gynecology, University Hospitals Medical Center and Case Western Reserve University, Cleveland, OH, USA.
Pai-Lien ChenFHI 360, Durham, NC, USA.
Beatrice A ChenDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh and Magee-Womens Research Institute, Pittsburgh, PA, USA.
Alisa B GoldbergPlanned Parenthood League of Massachusetts, Boston, MA, USA.
Jennifer L KernsDepartment of Obstetrics, Gynecology and Reproductive Sciences, Center for Global Reproductive Health, University of California, San Francisco, San Francisco, CA, USA.
Clint DartHealth Decisions, Durham, NC, USA.
Anita L NelsonEssential Access Health, Los Angeles, CA, USA.
Michael A ThomasDepartment of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, OH, USA.
David F ArcherDepartment of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA.
Jill E BrownContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Paula M CastañoDepartment of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, NY, USA.
Anne E BurkeDepartment of Gynecology and Obstetrics, Johns Hopkins University, Baltimore, MD, USA.
Bliss KaneshiroDepartment of Obstetrics, Gynecology, and Women's Health, University of Hawaii, Honolulu, HI, USA.
Diana L BlitheContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Family Health International 360 · USNational Institutes of Health · USPlanned Parenthood · USBoston University · USColumbia University Irving Medical Center · USEastern Virginia Medical School · USHawaii Department of Health · USHealth Decisions (United States) · USJohns Hopkins University · USOregon Health & Science University · USReproductive Science Center · USUniversity Hospitals of Cleveland · USUniversity of California, Davis · USUniversity of Cincinnati · USUniversity of Pennsylvania · USUniversity of Pittsburgh · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users. Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment. Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini ( Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy. Funding: Bill & Melinda Gates Foundation,

Indexed as

12-MonthBleeding and painBlindedComparativeContinuation ratesCopper intrauterine deviceEarly removalExpulsionIUDNulliparousRandomizedSatisfactionTrial

Identifiers

PMID35865736
PMCPMC9294241
OpenAlexW4285585553

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.