Midwives’ contribution to normal childbirth care: Cross-sectional study in public hospitals in Catalonia
| ISRCTN | ISRCTN14062994 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14062994 |
| Protocol serial number | N/A |
| Sponsor | Catalonia Nurses Colleges Council (Consell de Col·legis d'Infermeres i Infermers de Catalunya) |
| Funder | Catalonia Nurses Colleges Council |
- Submission date
- 28/09/2015
- Registration date
- 11/12/2015
- Last edited
- 04/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
When a pregnant woman is fit and healthy, it is more likely that she will have a birth without complications that could affect the mother or child’s health (normal birth). Studies have shown that there is a great variation in the care that women receive when they are in hospital giving birth. There is also a rising concern that this variability may affect the overall health of the babies that are born (birth outcomes), such as birth weight, or how far along in the pregnancy the mother was before giving birth (gestational age). This study will look at births taking place in public hospitals in Catalonia (Spain) in order to find out how many normal births are attended by midwives, and comparing this to birth outcomes.
Who can participate?
Healthy women between 18 and 40 years old with a single child pregnancy.
What does the study involve?
All of the participating hospitals register the information of women who attend the hospital to give birth and record the specific care that she receives during labour, delivery and shortly after birth. The number of births attended by midwives is recorded, as well as recording birth outcomes (health of the baby at the time of birth).
What are the possible benefits and risks of participating?
There are no direct benefits or risks for participants taking part in the study.
Where is the study run from?
Hospital General de l’Hospitalet (lead centre) and 12 other public hospitals in Catalonia (Spain)
When is the study starting and how long is it expected to run for?
September 2015 to December 2017
Who is funding the study?
Catalonia Nurses Colleges Council (Spain)
Who is the main contact?
Dr Ramón Escuriet
Contact information
Scientific
Riera de Sant Miquel, 61. 1
Barcelona
08006
Spain
 ORCID ID |
0000-0002-7277-3331 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective multi-centre cross-sectional study |
| Secondary study design | Cross sectional study |
| Scientific title | MIDwives CONtribution to childbirth care provision versus other health professionals childbirth care provision and BIRTH outcomes in public hospitals in Catalonia |
| Study acronym | MIDCONBIRTH |
| Study objectives | The aim of this study is to find out the proportion of normal births attended to by midwives in public hospitals in Catalonia. |
| Ethics approval(s) | Comité Ético de Investigación Clínica del Consorci Sanitari Integral, 16/12/2015, ref: 15/74 |
| Health condition(s) or problem(s) studied | Pregnancy |
| Intervention | In this study the intervention considered is the care provided to low risk women during labour, delivery and early postpartum period. This intervention includes all procedures performed during the intrapartum care process. For that purpose, the health professional profile attending to the woman and data related to diagnoses and procedures performed to each woman who meet inclusion criteria will be registered. Each participating hospital will register data from all low risk women being admitted for labour during a four months period or until a representative sample is achieved for each hospital, according to the annual volume of births attended to in the hospital. Participating hospitals will be progressively included during the study period until June 2017. |
| Intervention type | Other |
| Primary outcome measure(s) | Percentage of low risk births attended to by midwives in public hospitals in Catalonia during the study period. |
| Key secondary outcome measure(s) | Outcomes of births attended to by midwives, measured using Bologna Score within 24 hours after birth and before discharge from maternity ward. |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 1434 |
| Total final enrolment | 11537 |
| Key inclusion criteria | 1. Aged between 18 and 40 years 2. Female participants 3. Singleton pregnancy 4. Cephalic presentation of the foetus 5. Labour between 37 and 42 weeks gestation |
| Key exclusion criteria | 1. High or very high risk during pregnancy 2. Newborn Congenital disease detection after childbirth |
| Date of first enrolment | 01/12/2015 |
| Date of final enrolment | 01/06/2017 |
Locations
Countries of recruitment
- Spain
Study participating centres
L'Hospitalet De Llobregat
Barcelona
08906
Spain
Sabadell
Barcelona
08208
Spain
Barcelona
08243
Spain
Martorell
Barcelona
08760
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Not provided at the time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/11/2021 | 13/12/2021 | Yes | No | |
| Interim results article | 13/11/2020 | 04/01/2023 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/01/2023: Publication reference added.
13/12/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
11/01/2015: Ethical approval updated and Fundació Hospital Sant Joan de Déu de Martorell added as a trial participating centre.
