Bladder Care Clinical Trial
Official title:
Women's Experiences of Maternity Bladder Care
| Verified date | July 2017 |
| Source | University of Southampton |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | June 30, 2017 |
| Est. primary completion date | June 30, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Southampton | Southampton | Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Southampton | National Institute for Health Research, United Kingdom |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Women's experiences of bladder care during the antepartum, intrapartum and postpartum period | 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 |