WeBirthStudy: Questionnaire for assessing waterbirth experience design and validation
| ISRCTN | ISRCTN48249712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48249712 |
- Submission date
- 21/06/2020
- Registration date
- 01/07/2020
- Last edited
- 15/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Water birth is the process of giving birth in water using a deep bath or birthing pool. Being in water during labour can help with pain as well as being more relaxing and soothing than being out of water. The water can help to support the weight, making it easier to move around and feel more in control during labour. Waterbirth has become an increasingly popular childbirth option. However, there is no specific questionnaire for evaluating waterbirth experience. The aim of this study was to design and develop a self-reporting questionnaire to evaluate the waterbirth experience.
Who can participate?
Adult women who have experience of waterbirth, and can speak Spanish.
What does the study involve?
The study sample will be recruited in Hospital Germans trias i Pujol, located in the Barcelona region and belong to the Catalan Health Service. Participants will be informed of the nature of the study and recruited in the delivery room or hospitalization ward. Recruitment will be continuous throughout different time periods on all days of the week during the period October 2022 to December 2024. Spanish Questionnaire for Assessing Waterbirth Experience (QAWE) version will be sent to the participants online between 1 and 3 months postpartum together a questionnaire on sociodemographic and clinical variables.
The study involves the waterbirth experience questionnaire creation and the description of the obstetrical and neonatal results obtained and also the description of the facility agents and barriers of waterbirth.
What are the possible benefits and risks of participating?
There are no risks of participating since postpartum women have to answer an online questionnaire after one month of birth. However, they will be contributing to the creation of a valid and reliable instrument, which allows health professionals to evaluate waterbirth experience and can be used to assess the quality of health care, incorporating the point of view of women, and contribute to the evaluation and monitoring of the changes introduced with the new delivery care model.
Where is the study run from?
Hospital Germans Trias i Pujol (Badalona) Spain.
When is the study starting and how long is it expected to run for?
June 2020 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Pablo Rodríguez Coll, prodriguezc.germanstrias@gencat.cat
Eva Gilaberte Martínez: eva.gilaberte@gmail.com
Roser Palau Costafreda, roser.palau@gmail.com
Contact information
Scientific
Ronda Pinetons 6
Mollet del Vallés
Barcelona
08100
Spain
 ORCID ID |
0000-0002-9296-4178 |
|---|---|
| Phone | +34 633136676 |
| prodriguezc.germanstrias@gencat.cat |
Public
Av. Mancomunitats Comarcals, 1, 3
Martorell
Barcelona
08760
Spain
| Phone | +34 696935618 |
|---|---|
| roser.palau@gmail.com |
Study information
| Study design | Multicentre observational transverse trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN48249712_PIS.docx |
| Scientific title | Design and validation of a questionnaire for assessing waterbirth experience |
| Study acronym | WeBirthStudy |
| Study hypothesis | Waterbirth has become an increasingly popular childbirth option. However, there is no specific questionnaire for evaluating waterbirth experience. The aim of this study was to design and develop a self-reporting questionnaire to evaluate the waterbirth experience |
| Ethics approval(s) |
Approved 17/12/2021, COMITÉ DE ÉTICA DE LA INVESTIGACIÓN - HOSPITAL UNIVERSITARIO GERMANS TRIAS I PUJOL (Ctra. de Canyet s/n, Badalona, Barcelona, 08916, Spain; +34 934 65 12 00; avaluacionsceic.germanstrias@gencat.cat), ref: PI-21-326 |
| Condition | Screening tool for evaluating waterbirth experience |
| Intervention | Participants will be informed and recruited in the delivery room or hospitalization ward. They will receive an e-mail from one to two months after waterbirth, inviting them to answer the online questionnaire that includes the created waterbirth questionnaire and a questionnaire on sociodemographic variables. If they do not answer, they will be recalled by the researcher's team. Once they answer the e-mail, their participation will be finished. |
| Intervention type | Other |
| Primary outcome measure | Waterbirth Experience will be evaluated using the created specific questionnaire one month after birth as a minimum. |
| Secondary outcome measures | 1. Obstetrical results from participants will be obtained and of measured using hospital records 2. Neonatal results of participants' children will be obtained and measured using hospital records 3. Waterbirth facilitators and barriers will be obtained and measured from two focus group composed of 5 postpartum women who gave birth in water. Information will be recorded, transcribed and triangulated to obtain those barriers and facilitators identified by women participating in this phase of the study. Phase I: questionnaire creation |
| Overall study start date | 15/06/2020 |
| Overall study end date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Between 15 and 20 per item |
| Participant inclusion criteria | Current inclusion criteria as of 20/10/2023: 1. Older than 18 years 2. Able to understand Spanish 3. Have computer knowledge in order to answer an online questionnaire 4. Have used water immersion during birth _____ Previous inclusion criteria: 1. Older than 18 years 2. Able to understand Spanish 3. Have computer knowledge in order to answer an online questionnaire 4. Have given birth using waterbirth |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 11/10/2022 |
| Recruitment end date | 01/12/2025 |
Locations
Countries of recruitment
- Spain
Study participating centre
Badalona
08916
Spain
Sponsor information
Hospital/treatment centre
Ronda Pinetons, 6
Mollet del Vallès
Barcelona
08100
Spain
| Phone | +34 935 63 61 00 |
|---|---|
| gestioconeixement@fsm.cat | |
| Website | https://www.fsm.cat/web/ |
Hospital/treatment centre
Av. Mancomunitats Comarcals, 1, 3
Martorell
Barcelona
08760
Spain
| Phone | +34 937 74 20 20 |
|---|---|
| uac@hmartorell.es | |
| Website | https://fhsjdm.cat/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 03/07/2020 | No | Yes |
Additional files
- ISRCTN48249712_PIS.docx
- Uploaded 03/07/2020
Editorial Notes
15/01/2025: The following changes were made:
1. The overall end date was changed from 01/12/2024 to 01/12/2025.
2. The recruitment end date was changed from 01/12/2024 to 01/12/2025.
3. The intention to publish date was changed from 01/11/2025 to 01/11/2026
20/10/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The overall end date was changed from 01/07/2021 to 01/12/2024.
3. The inclusion criteria were changed.
4. The recruitment start date was changed from 24/07/2020 to 11/10/2022.
5. The recruitment end date was changed from 31/12/2020 to 01/12/2024.
6. The study participating centres Fundació Hospital Sant Joan de Déu de Martorell, Hospital de Mollet were removed and Hospital Germans Trias i Pujol was added.
7. The plain English summary was updated to reflect these changes.
8. The intention to publish date was changed from 01/07/2022 to 01/11/2025.
9. The contact emails were updated.
03/07/2020: Uploaded protocol (not peer reviewed).
01/07/2020: Trial’s existence confirmed by Fundacio Sanitaria Mollet
