Evidence map›Paper›PMID 30849305›Full record

Trial reportContraception2019

Acceptability of the Woman's Condom in a phase III multicenter open-label study.

Beatrice A Chen, Diana L Blithe, Gitonga R Muraguri, Audrey A Lance, Bruce R Carr, Jeffrey T Jensen, Thomas D Kimble, Amitasrigowri S Murthy, Courtney A Schreiber, Michael A Thomas and 3 more

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Contraception, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

13 authors.

Beatrice A ChenDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, USA. Electronic address: chenba@upmc.edu.
Diana L BlitheContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Dr, Bethesda, MD 20817, USA.
Gitonga R MuraguriHealth Decisions Inc., 2510 Meridian Parkway, Durham, NC 27713, USA.
Audrey A LanceDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA, USA; Northland Family Planning, 35000 Ford Road, Westland MI 48185, USA.
Bruce R CarrDepartment of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA.
Jeffrey T JensenDepartment of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.
Thomas D KimbleDepartment of Obstetrics and Gynecology, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA 23323, USA.
Amitasrigowri S MurthyDepartment of Obstetrics and Gynecology, NYU School of Medicine, Bellevue Hospital Center, 462 First Ave, New York, NY 10016, USA.
Courtney A SchreiberDepartment of Obstetrics and Gynecology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.
Michael A ThomasDepartment of Obstetrics & Gynecology, University of Cincinnati Medical Center, 234 Goodman St, Cincinnati, OH 45219, USA.
Terri L WalshEssential Access Health, 3600 Wilshire Blvd, Suite 600, Los Angeles, CA 90010, USA.
Carolyn WesthoffDepartment of Obstetrics & Gynecology, Columbia University, 622 West 168th St, PH 16, New York, NY 10032, USA.
Anne E BurkeDepartment of Gynecology & Obstetrics, Johns Hopkins University, 4940 Eastern Ave, Baltimore, MD 21224, USA.

Funding

Development of novel contraceptive methods for men and womenZIBHD008987 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI BLITHE, DIANA · 2019 to 2025
$7.2M
Intramural NIH HHS Z99 HD999999
6 · The paper itself

Abstract

objectiveThis study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial. STUDY

designWe assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions.

resultsMost women [327/405 (81%)] had limited or no previous experience with female (internal) condoms. Of 405 evaluable women, 346 women completed questionnaires at visit 2 and 303 women at visit 3; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at visit 3 (p=.03). Many women [166/281 (59%)] preferred the WC [105/281 (37%)] or were neutral [61/281 (22%)], while 115/281 (41%) preferred male condoms. Women attending visit 3 felt confident that the WC could prevent pregnancy [246/303 (81%)] and STIs [217/303 (72%)]. Many women expressed empowerment with having control over their contraception; some disliked the design, esthetics and insertion process. Most women (254/299 (85%)] would recommend the WC to a friend.

conclusionThe WC's acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs. IMPLICATIONS: The WC's overall acceptability and ease of use is promising for a new female-controlled barrier contraceptive option that can protect against both pregnancy and sexually transmitted infections.

Indexed as

Health Knowledge, Attitudes, PracticeAdolescentAdultContraception BehaviorFamily Planning ServicesFemaleHumansPatient Acceptance of Health CarePregnancySexually Transmitted DiseasesSingle-Use Internal CondomSurveys and QuestionnairesUnited StatesWomen's HealthYoung AdultAcceptabilityBarrier methodsContraceptionFemale condomInternal condomWoman's Condom

Identifiers

PMID30849305
PMCPMC7363037

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.