Bladder CareNCT03084354
Women's Experiences of Maternity Bladder Care
An observational study of Bladder Care, run by University of Southampton at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Care
- What is being tested?
- Semi-structured interviews
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population is women who have received antepartum, intrapartum and postpartum care at the designated hospital and have birthed a live singleton, term baby (37-42 weeks gestation) between two weeks to six months prior to the interview.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO17 1BJ
About this study
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.
Read more
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.
- Conditions
- Bladder Care
- Being tested
- Semi-structured interviews
- Keywords
- pelvic floor, women's experiences, bladder care, pregnancy, labour, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start25 Jul 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Dr Ellen Kitson-Reynolds, Study chair, University of SouthamptonVeronica Blanco-Gutierrez, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084354
- Sponsor's protocol ID
- 19544
- Status last verified
- Jul 2017
- First submitted
- 7 Mar 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Experiences of Maternity Bladder Care
- ClinicalTrials.gov ID
- NCT03084354
- Acronym / sponsor ID
- 19544
- Conditions
- Bladder Care
- Keywords
- pelvic floor, women's experiences, bladder care, pregnancy, labour, postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is women who have received antepartum, intrapartum and postpartum care at the designated hospital and have birthed a live singleton, term baby (37-42 weeks gestation) between two weeks to six months prior to the interview.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsSemi-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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ellen Kitson-Reynolds study chair
University of Southampton
Veronica Blanco-Gutierrez principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Care, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's experiences of bladder care during the antepartum, intrapartum and postpartum period (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.