Evidence map›Paper›PMID 41000288›Full record

ArticleO&G open2025

Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter.

Rebecca F Dunsmoor-Su, Vrunda B Desai, Erica C Pandolfi, Corinne R Audette, Joyce R Miller, Ashley E Fuller, Eric L Brown, Ron D Hirth, Karen V Seetal-Kihei, Laura F McKain

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in O&G open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05309694 (A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT05309694 phase4completednot on this map

A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive

TypeinterventionalSponsorCooperSurgical Inc.Ran2022 to 2022Enrolled119ConditionsContraceptionArmsParagard® T380A Intrauterine Copper Contraceptive with New Inserter
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Rebecca F Dunsmoor-SuSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Vrunda B DesaiSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Erica C PandolfiSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Corinne R AudetteSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Joyce R MillerSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Ashley E FullerSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Eric L BrownSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Ron D HirthSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Karen V Seetal-KiheiSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Laura F McKainSeattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this clinical trial, a preassembled, single-hand Paragard T380A intrauterine copper contraceptive device inserter was investigated for insertion success and safety. The single-hand inserter was evaluated in a phase 4 multicenter study of 117 participants (NCT05309694). Successful insertion of the intrauterine system (IUS) was achieved on first attempt for 90.6% of participants (106/117) and on second attempt for 100% of participants (10/10), for an overall success rate of 99.1% (116/117). Investigators found the inserter easy to use and perceived a reduced time of insertion. No safety signals related to insertion were observed. After successful insertion, two participants experienced serious adverse events associated with major protocol deviations: uterine perforation and embedded IUS. Overall, the single-hand inserter for the T380A intrauterine copper contraceptive device demonstrated successful insertion. CLINICAL

trial registrationClinicalTrials.gov, NCT05309694.

Identifiers

PMID41000288
PMCPMC12456594

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.