Evidence map›Paper›PMID 29269252›Full record

Trial reportContraception2018

Factors associated with nonadherence to instructions for using the Nestorone®/ethinyl estradiol contraceptive vaginal ring.

Bianca M Stifani, Marlena Plagianos, Carolina Sales Vieira, Ruth B Merkatz

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Contraception, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Use of simulated vaginal and menstrual fluids to modelInternational journal of pharmaceutics: X · 2021
    Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Advances in contraception: vaginal contraceptive rings.Therapeutic advances in reproductive health
    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

4 authors at 3 institutions in 2 countries.

Bianca M StifaniDepartment of Obstetrics, Gynecology and Women's Health of Albert Einstein College of Medicine/Montefiore Medical Center, 1300 Morris Park Avenue, Bronx, NY, 10461, USA; Population Council, 1230 York Avenue, New York, NY, 10065, USA.
Marlena PlagianosPopulation Council, 1230 York Avenue, New York, NY, 10065, USA.
Carolina Sales VieiraPopulation Council, 1230 York Avenue, New York, NY, 10065, USA; Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo. Avenida Bandeirantes, 3900-Campus Universitário-Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.
Ruth B MerkatzPopulation Council, 1230 York Avenue, New York, NY, 10065, USA. Electronic address: rmerkatz@popcouncil.org.
Population Council · USAlbert Einstein College of Medicine · USUniversidade de São Paulo · BR

Funding

Assessing &Improving the Measurement of Sexual BehaviorR01HD047764 · NICHD · POPULATION COUNCIL · PI MENSCH, BARBARA SENA · 2005 to 2008
$2.0M
NICHD NIH HHS R01 HD047764
6 · The paper itself

Abstract

objectivesWe sought to identify factors associated with nonadherence to instructions for using a novel contraceptive providing 1 year of protection. STUDY

designData from a multicountry Phase 3 trial of the Nestorone® (segesterone acetate)/ethinyl estradiol (NES/EE) contraceptive vaginal ring (CVR) were analyzed. Participants were instructed to use the CVR over 13 cycles and follow a 21/7 regimen. Their reports of CVR removals >2 h outside scheduled removal periods served as a proxy for nonadherence. We used multivariate logistic regression to determine factors associated with such use.

resultsOf 905 participants, 120 (13%) reported CVR removals >2 h. Removals for washing [odds ratio (OR) 3.96, 95% confidence interval (CI) 2.50-6.27] or sexual intercourse (OR 3.19, 95% CI 2.03-4.99), and finding CVR insertion difficult (OR 2.80, 95% CI 1.36-5.80) were factors associated with removals >2 h. Lower educational attainment also predicted ring removal >2 h (OR 3.23, 95% CI 1.55-6.75). Women residing in Europe or Australia were less likely to remove the ring for >2 h compared with women in the United States (OR 0.44, 95% CI 0.24-0.83 and OR 0.13, 95% CI 0.02-0.98, respectively). Participants who reported removals >2 h were more likely to discontinue CVR use (OR 1.93, 95% CI 1.24-2.95), report dissatisfaction (OR 2.20, 95% CI 1.32-3.69) and become pregnant during the study (OR 4.07, 95% CI 1.58-10.50).

conclusionsRemoving the CVR for washing and removing it before intercourse are factors associated with nonadherence to ring use. These are important topics for counseling women who are considering or using vaginal rings, including the NES/EE CVR. IMPLICATIONS: Findings from this study may be useful in guiding counseling for current and prospective vaginal ring users. Anticipatory guidance should focus on how the ring feels in the vagina and during sex. Asking about ring removals may help identify women who are at increased risk for having an unplanned pregnancy.

Indexed as

Contraceptive Devices, FemalePatient ComplianceAdultContraceptive Agents, FemaleEthinyl EstradiolFactor Analysis, StatisticalFemaleHumansInternationalityLogistic ModelsMultivariate AnalysisNorprogesteronesYoung AdultContraceptive Agents, FemaleEthinyl EstradiolNorprogesteronesST 1435AcceptabilityAdherenceContraceptionVaginal ring

Identifiers

PMID29269252
PMCPMC5948138
OpenAlexW2776229893

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.