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Effect of the Intervention applied to the Exam of Cervical Cancer Prevention and the evaluation of the adequacy of the sampling of the cells collected

Effect of the intervention applied to the Papanicolaou Test and the Adequability of the cytopathological sample

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2h4mpn
Enrollment
Unknown
Registered
2019-01-16
Start date
2018-08-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms

Interventions

It will be divided two groups, one of intervention and the other of control. In the intervention, will be carried out the preventive examination of Cervical Cancer according to the technique and the m
and the other control group will not receive exactly the same recommendations, and the routine preventive test will be performed, as recommended in 2006. The intervention and control group will be com
Procedure/surgery
Behavioural
E01.370.225.500.384.100.800

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women who have already started sex life; women to undergo cervical cancer screening at the time of data collection.

Exclusion criteria

Exclusion criteria: Patients younger than 18 years; pregnant women; women who are in the menstrual period or have undergone total hysterectomy; collection slides that have been exposed to conditions of poor storage, transportation and other logistic factors unrelated to the preparation with the uterine cervix material; unavailability of the cytopathological report at the research place.

Design outcomes

Primary

MeasureTime frame
It is intended to evaluate the relevance of the recommendation of disposition on the smear blade of the ectocervix cells of the cervix only after collection of the endocervix material. The population of the research will correspond to the universe of women attended at the CPN, more specifically in the gynecological nursing consultations, to perform the Papanicolau. The sample size was calculated using the formula for studies with comparative groups (JEKEL; ELMORE; KATZ, 2005). For this study, because it is unprecedented, the proportion of occurrence of the adopted outcome will be 50%. Thus, by substituting the following values in formula: Za = 95% (1,96), Zb = 80% (0,84), p = 50% e d = 15%; the sample size was 196 participants for each group, totaling 392 women.

Secondary

MeasureTime frame
To evaluate the effect of the intervention applied on the cytological result and the sociodemographic and gynecological factors that may be conditioning the result; (p <0.05) and the Odds Ratio (OR) will be considered statistically significant, where p is less than 0.05 (p <0.05) with a 95% confidence interval. Continuous variables will be expressed as mean ± standard deviation, with a 95% confidence interval and frequency and percentage categories. In order to have a normal distribution, the continuous data will be evaluated by the Kolmogorov-Smirnov (KS) test (FIELD, 2009).

Countries

Brazil

Contacts

Public ContactVívien Freitas

Universidade Federal do Ceará

vivien-alves@hotmail.com+5585997814356

Outcome results

None listed

Source: REBEC (via WHO ICTRP)