Safety, experiences and economic cost of planned home birth in Catalonia

ISRCTN	ISRCTN94453122
DOI	https://doi.org/10.1186/ISRCTN94453122
Secondary identifying numbers	IIBSP-PAR-2018-81

Submission date: 14/10/2018
Registration date: 09/11/2018
Last edited: 13/12/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Recent studies show that planned home birth is a safe option for low-risk women. These studies look at different aspects: safety in terms of health problems for the mother and baby resulting from the birth, women's experiences of the birth and its economic costs. These three dimensions of childbirth care are measured comparing the birthplace chosen by women and the type of professional attending childbirth. These studies conclude that home birth is as safe as or even safer than hospital birth for women with straightforward pregnancies (without any risk factor until labour starts), it is a satisfactory experience and it is cost effective.
In Spain, planned home birth is a private service provided by midwives. More than one third of all annual Spanish home births take place in Catalonia. The Catalonian home birth midwives' association, Associació de llevadores de part a Casa de Catalunya (ALPACC), collects data in a database of all births planned at home with the associated midwives. This database will be one of the sources used for the first and third phases of this study.
This study is planned in 3 phases and aims to investigate if home birth with midwives in Catalonia is safe (phase 1), if it is a satisfactory experience (phase 2) and if it is sustainable (phase 3).

Who can participate?
Pregnant women aged between 18 and 40 years with normal or low-risk pregnancies.

What does the study involve?
Phase 1 will involve analysis of the ALPACC database by the researchers. For Phase 2, participants will be sent a questionnaire relating to their experience of the birth 15 to 30 days after they have given birth. For Phase 3, midwives will be sent a questionnaire to record the hours of work, cost of materials used and time spent in hospital for each birth.

What are the possible benefits and risks of participating?
Participating in this study has no benefits or risks for the participating women, as the care being studied is that routinely provided.

Where is the study run from?
Universitat Pompeu Fabra, Catalonia, Spain

When is the study starting and how long is it expected to run for?
January 2016 to June 2020

Who is funding the study?
The researchers are funding the study.

Who is the main contact?
Lucia Alcaraz-Vidal, lucialcaraz1@gmail.com

Contact information

Mrs Lucia Alcaraz
Scientific

Gran Via de les Corts Catalanes 410 principal 1a
Barcelona
08015
Spain

Phone	+34 656594895
Email	lucialcaraz1@gmail.com

Study information

Study design	Observational multicenter cross-sectional cohort study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Home
Study type	Quality of life
Scientific title	Maternal and neonatal outcomes on planned homebirth assisted by midwives in Catalonia: Cross-sectional study
Study acronym	HomebirthCat I
Study objectives	Planned home birth for low-risk women assisted by midwives is safe, is a positive experience and has lower economic costs than hospital birth.
Ethics approval(s)	Approval has been requested from the ethics committee of Parc de Salut Mar (CEIC PSMAR) and the ethics committee of Hospital de la Sta. Creu i St.Pau. Study Code: IIBS-PAR-2018-81
Health condition(s) or problem(s) studied	Delivery
Intervention	For phase 1, the active participation of women will not be necessary; data will be collected from the databases. Participants in phase 2 will be recruited in the hospital and at home after delivery to be informed and obtain informed consent. After 15 days postpartum, the questionnaire will be sent by mail or will meet with their midwife who will provide the questionnaire in paper form. For phase 3, the active participation of women is not required; the questionnaire on costs will be completed by the midwife attending the birth.
Intervention type	Behavioural
Primary outcome measure	Phase 1: 1. Composite rate of neonatal death during labour and early neonatal death assessed using the ALPACC database with a 7 days follow-up time after the birth 2. Composite rate of maternal death during labour and early maternal death assessed using the ALPACC database with a 7 days follow-up time after the birth 3. Rate of postpartum haemorrhage measured after birth using the ALPACC database 4. Rate of perineal injury measured after birth using the ALPACC database 5. Rate of women admitted in intensive care unit after birth to 24 h postpartum using the ALPACC database. 6. Rate of neonates with neonatal encephalopathy measured 7 days after birth using the ALPACC database 7. Rate of neonates with Apgar score equal to 7 or lower, measured after birth using the ALPACC database. 8. Rate on neonates admitted into neonatal intensive care unit (NICU) from birth to 24 h after birth using the ALPACC database Phase 2: 1. Women’s perception of their own capacity during birth, assessed using the Childbirth Experience Questionnaire (CEQ-E), filled in between 30 days and 3 months after the birth 2. Women’s perception of the professional support during birth, assessed using the CEQ-E, filled in between 30 days and 3 months after the birth 3. Women’s perception of their safety during birth, assessed using the CEQ-E, filled in between 30 days and 3 months after the birth 4. Women’s perception of their participation during birth, assessed using the CEQ-E, filled in between 30 days and 3 months after the birth Phase 3: primary outcomes 1. Cost of labour and birth care measured using a questionnaire filled by midwives in the obstetric unit before discharge. 2. Human resources cost measured using a questionnaire filled by midwives in the obstetric unit before discharge 3. Material resources cost, measured using a questionnaire filled by midwives in the obstetric unit before discharge 4. Pain management cost, measured using a questionnaire filled by midwives in the obstetric unit before discharge 5. Structural costs, measured using a questionnaire filled by midwives in the obstetric unit before discharge
Secondary outcome measures	N/A
Overall study start date	01/01/2016
Completion date	31/05/2021

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Female
Target number of participants	340
Key inclusion criteria	1. Pregnant women aged 18-40 years with straightforward pregnancy 2. Labour starting spontaneously between 37 and 42 weeks 3. Single foetus in cephalic presentation 4. Labour assisted by midwives
Key exclusion criteria	1. Women with diseases or medical conditions that could influence birth outcomes 2. Women with serious complications in previous pregnancies 3. Women without antenatal care 4. Women with a BMI higher than 35 kg/m2 5. Women planning hospital birth but delivering at home or while going to the hospital 6. Women planning childbirth in a freestanding birth centre 7. Women with premature rupture of membranes for more than 72 hours 8. Women with previous caesarean section 9. Women with prenatal congenital malformation diagnosis
Date of first enrolment	01/01/2019
Date of final enrolment	30/06/2020

Locations

Countries of recruitment

Spain

Study participating centres

Sant Pau Hospital, Barcelona

Sant Antoni Maria Claret, 167
Barcelona
08025
Spain

Hospital Parc Salut Mar, Barcelona to Hospital Germans Trias i Pujol

Carretera del Canyes S/N
Barcelona
08916
Spain

Sponsor information

University Pompeu Fabra
University/education

Dr.Aiguader,80
Barcelona
08003
Spain

Phone	(+34) 93 316 35 01
Email	phdprogram.cexs@upf.edu
Website	https://www.upf.edu/web/phd-biomedicine
"ROR"	https://ror.org/04n0g0b29

Funders

Funder type

Other

Self funded

No information available

Results and Publications

Intention to publish date	01/03/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The first and second papers are going to to be published in 2019, with a third paper published in 2020.
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/07/2021	13/12/2023	Yes	No
Results article		27/11/2023	13/12/2023	Yes	No

Editorial Notes

13/12/2023: Publication references added.
25/01/2021: The following changes were made to the trial record:
1. The trial participating centre was changed from was changed from Hospital Parc Salut Mar, Barcelona to Hospital Germans Trias i Pujol.
2. The intention to publish date was changed from 01/06/2019 to 01/03/2021.