Condition category
Pregnancy and Childbirth
Date applied
21/06/2020
Date assigned
01/07/2020
Last edited
03/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 Fundació Hospital Sant Joan de Déu de Martorell and Hospital de Mollet; both hospitals are 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 July 2020 to January 2021. 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?
1. Fundació Hospital Sant Joan de Déu de Martorell (Spain)
2. Hospital de Mollet (Spain)

When is the study starting and how long is it expected to run for?


Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Pablo Rodríguez Coll, pa.rodriguez@fsm.cat
Roser Palau Costafreda, roser.palau@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Pablo Rodriguez Coll

ORCID ID

https://orcid.org/0000-0002-9296-4178

Contact details

Ronda Pinetons 6
Mollet del Vallés
Barcelona
08100
Spain
+34 633136676
pa.rodriguez@fsm.cat

Type

Public

Additional contact

Ms Roser Palau Costafreda

ORCID ID

Contact details

Av. Mancomunitats Comarcals
1
3
Martorell
Barcelona
08760
Spain
+34 696935618
rpalau@hmartorell.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Design and validation of a questionnaire for assessing waterbirth experience

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

Not provided at time of registration

Study design

Multicentre observational transverse trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

See additional files

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

Phase

Drug names

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 trial start date

15/06/2020

Overall trial end date

01/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Between 15 and 20 per item

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

24/07/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Spain

Trial participating centre

Fundació Hospital Sant Joan de Déu de Martorell
Av. Mancomunitats Comarcals, 1, 3,
Martorell
08760
Spain

Trial participating centre

Hospital de Mollet
Ronda Pinetons, 6
Mollet del Vallés
08100
Spain

Sponsor information

Organisation

Hospital de Mollet

Sponsor details

Ronda Pinetons
6
Mollet del Vallès
Barcelona
08100
Spain
+34 935 63 61 00
gestioconeixement@fsm.cat

Sponsor type

Hospital/treatment centre

Website

https://www.fsm.cat/web/

Organisation

Fundació Hospital Sant Joan de Déu de Martorell

Sponsor details

Av. Mancomunitats Comarcals
1
3
Martorell
Barcelona
08760
Spain
+34 937 74 20 20
uac@hmartorell.es

Sponsor type

Hospital/treatment centre

Website

https://fhsjdm.cat/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/07/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2020: Uploaded protocol (not peer reviewed). 01/07/2020: Trial’s existence confirmed by Fundacio Sanitaria Mollet