NCT03084354

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

March 7, 2017

Last Update Submit

July 10, 2017

Conditions

Keywords

pelvic floorwomen's experiencesbladder carepregnancylabourpostpartum

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

Related Links

Study Officials

  • Dr Ellen Kitson-Reynolds

    University of Southampton

    STUDY CHAIR
  • Veronica Blanco-Gutierrez

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 20, 2017

Study Start

July 25, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations