- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03084354
Women's Experiences of Maternity Bladder Care
Background.
Although a healthy urinary system is a vital aspect in every woman's life, bladder management is an aspect of maternity care, which is, or perceived as, being poorly managed by health care professionals. Furthermore, although the relationship between childbirth and bladder dysfunction is an incontestable fact very well documented in the medical literature, women's experiences of bladder care have not been recognized by the evidence, and therefore, no research has been developed to address this topic. This fact implies a limited level of awareness and degree of implication from women in this matter.
Research question.
What are women's experiences, perceptions and knowledge of bladder care during the antepartum, intrapartum and postpartum period?
Aim.
To explore women's experiences of bladder care during the antepartum, intrapartum and postpartum period.
Design.
Exploratory, descriptive research study.
Population.
Women who have given birth to a singleton, live, term baby between two weeks and six months prior the study, and who meet the inclusion and exclusion criteria.
Methods.
In-depth semi-structured interviews.
Sample.
A purposive sample of eight to sixteen women, with a heterogeneous representation of the different modes of birth, will be sought.
Recruitment.
Postnatal midwives will act as gatekeepers identifying potential participants and providing information packs. Other recruitment resources will include posters and a study website, which will be advertised at local maternity groups.
Data collection.
Semi-structure interviews to gain a deep understanding of women's experiences of maternity bladder care. Interviews will last between thirty minutes to a couple of hours and they will be digitally recorded and transcribed verbatim.
Data Analysis.
Framework analysis assisted by memoing technique.
Ethical considerations.
Ethical approval from the Sponsor and the Health Research Authority will be sought.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Hampshire
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Southampton, Hampshire, United Kingdom, SO17 1BJ
- University of Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women who have received antepartum, intrapartum and postpartum care at the designated hospital.
- Women who have given birth to a live singleton, term (37 to 42 weeks gestation) infant between two weeks and six months ago at the designated hospital.
- Women who have been identified and received the information pack by the named postnatal midwife. Alternatively, potential participants can also get included in the study after being self-referred through local maternity groups (posters, leaflets, (PDF file) webpages and study website).
Exclusion Criteria:
- Women and newborns with serious medical/life threatening conditions (pre-existing mental health, neurological, uro-genital conditions, pregnancy related complications and/or newborn related conditions, such us, preterm delivery, fetal abnormalities, admission to the neonatal unit and poor condition at birth).
- Women who have experienced a stillbirth, neonatal death or traumatic birth.
- Women who are not fluent in English, although Spanish participants will be included as the main researcher is fluent in both languages.
- Women under the age of eighteen.
- Women who are unable to be interviewed due to cognitive impairment or disabilities.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Women's experiences of bladder care during the antepartum, intrapartum and postpartum period
Time Frame: day 1
|
Qualitative semi-structured interviews performed at one occasion where the participant describes her experience of bladder care during pregnancy, labour and after birth.
|
day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Dr Ellen Kitson-Reynolds, University of Southampton
- Principal Investigator: Veronica Blanco-Gutierrez, University of Southampton
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19544
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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