NCT06791252

Brief Summary

Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. The hypotheses of this study were determined as follows: H1a: Genital hygiene education affects genital hygiene behavior in pregnant women. H1b: Genital hygiene education affects self-care ability in pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
Last Updated

January 29, 2025

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

January 16, 2025

Last Update Submit

January 27, 2025

Conditions

Keywords

Midwifepregnanthygieneself-careurinary tract infections

Outcome Measures

Primary Outcomes (1)

  • genital hygiene behavior

    Considering that behaviors regarding genital hygiene are established from an early age, it is important to objectively determine risky behaviors in young women who are not yet sexually active in order to take precautions for improving genital hygiene.In this way, many negative outcomes that may occur during the fertile period and are directly related to genital infections, such as infertility, abortion, and the threat of premature birth,can be prevented.On the other hand, it would be useful to use an objective, valid, and reliable measurement tool in determining the relationship between genital hygiene behaviors in women and situations such as the threat of premature birth, premature rupture of membranes, and postpartum infection.The primary outcome of this study is to determine the genital hygiene behaviors of the hygiene education given to women who have previously had urinary tract infections.For this purpose, the General Hygiene Habit and Abnormal Finding Awareness scale was used.

    30 days

Secondary Outcomes (1)

  • Self-Care Ability

    30 days

Study Arms (2)

Group receiving genital hygiene education

EXPERIMENTAL

Pregnant women in the experimental group were given genital hygiene training in 4 sessions.

Behavioral: genital hygiene education

Control Group

NO INTERVENTION

No intervention was applied to the control group other than the application of data collection tools simultaneously with the pregnant women in the experimental group (pre-test: 1st session/1st day - post-test: 2nd session/30th day).

Interventions

The pregnant women in the experimental group were given genital hygiene training individually and in their own homes by the researcher. During the training, the privacy of the client was observed and the researcher and the pregnant women were left alone in the room where the training would be given. Care was taken to ensure that the environment was quiet and calm while the training was given. It was preferred that the pregnant women be in the most comfortable position during the training. The training was completed by explaining each topic in the training booklet in an average of 20-25 minutes. Genital hygiene training content: Session 1 (Day 1): After the introduction phase, information was given about the method to be followed in the study to the pregnant women who agreed to participate in the study. Then, the "Minimum Informed Consent Form" was given to these women, and the pregnant women who approved the form after reading it were included in the study. Pre-test data were collecte

Group receiving genital hygiene education

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All pregnant women who were literate, - Who had completed their pharmacological treatment (antibiotic treatment) for UTI according to medical records were included in the sample

You may not qualify if:

  • \- Those who had previously received training to increase genital hygiene behavior,
  • Those who had a risky pregnancy,
  • Those who were diagnosed with any health problems related to the pregnant woman and the fetus were not included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya

Malatya, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: randomized controlled trial conducted with experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 24, 2025

Study Start

September 30, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

January 29, 2025

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Research results will be shared

Locations