Midwives’ contribution to normal childbirth care. Cross-sectional study in public health settings
| ISRCTN | ISRCTN17833269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17833269 |
| Secondary identifying numbers | 2016/6785/I |
- Submission date
- 14/10/2016
- Registration date
- 19/10/2016
- Last edited
- 18/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Recent research suggests that there is some variability in the care that is given to women and their babies during labour and immediately after birth (intrapartum care). Intrapartum care can include recommendations on where the baby should be delivered, pain relief during labour, care given in the first, second and third stages of labour and care of mother and baby after the birth. Variability in intrapartum care raises concerns about how this may impact on the health of some mothers and newborn babies. This study is looking at how many normal births are attended by midwives in public health settings (for example, hospitals) and at home and recording what happens during the birth and shortly afterwards.
Who can participate?
Women aged between 18-40 pregnant with one baby and about to give birth.
What does the study involve?
This study looks at the care provided for all participants during their labour, delivery of their baby and the care of themselves and their baby after the birth. Information on all participants is recorded by the attending midwife over a 4 month period, or until a representative sample of data is collected for each type of setting that a baby can be born (that is, hospital, birth centre or whether the baby is born at home with the help of a midwife).
What are the possible benefits and risks of participating?
Participating in this study has no benefits or risks for participating women, as the care being studied is that routinely provided.
Where is the study run from?
Four different hospitals in Spain.
When is the study starting and how long is it expected to run for?
October 2016 to December 2019
Who is funding the study?
Catalonia Council of Nurses
Who is the main contact?
Dr Ramón Escuriet
Contact information
Scientific
Doctor Aiguader, 80, 3ª Planta (Despatx 61.311)
Barcelona
08003
Spain
 ORCID ID |
0000-0002-7277-3331 |
|---|
Study information
| Study design | Prospective multicentre and cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | ISRCTN17833269_PIS_19Oct2016_Spanish.docx |
| Scientific title | MIDwives CONtribution to childbirth care provision versus other health professionals childbirth care provision and BIRTH outcomes in public health settings (Second Phase of Midconbirth study) |
| Study acronym | MIDCONBIRTH II |
| Study objectives | This study will find out the proportion of normal births attended to by midwives in public health settings in Spain and in other European participating countries |
| Ethics approval(s) | Ethics Committees of Clinical Research (Comité de Ética de Investigación Clínica del Parc Salut Mar), 25/05/2016, ref: 2016/6785/I |
| Health condition(s) or problem(s) studied | Childbirth |
| 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 setting or midwife 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 setting (hospital, birth center or home birth midwife, according to the annual volume of births attended to in the setting or by the participating midwife. Participating settings and midwives will be progressively included during the study period until June 2019 |
| Intervention type | Other |
| Primary outcome measure | Percentage of low risk births attended to by midwives in public health settings and publicly funded home births during the study period. Measure will consist in the identification of the health professional providing care and attending the delivery for each woman . |
| Secondary outcome measures | 1. Outcomes of births attended to by midwives, measured using Bologna Score within the 24 hours after birth and before discharge from maternity ward 2. Transfer rates from public birth centres and home births attended to by midwives to obstetric units |
| Overall study start date | 01/10/2016 |
| Completion date | 01/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1500 |
| Total final enrolment | 5497 |
| Key inclusion criteria | 1. Women aged 18 years or older 2. Women aged 40 years or younger 3. Singleton pregnancy 4. Cephalic presentation of the foetus 5. Not classified as women at high or very high risk during pregnancy 6. Starting labour from 37 (first day) weeks of pregnancy and before 41 (last day) weeks of pregnancy |
| Key exclusion criteria | 1. Women Aged 17 years or younger 2. Women Aged 41 years or older 3. No singleton pregnancy 4. No cephalic presentation of the foetus 5. Classified as women at high or very high risk during pregnancy 6. Starting labour before 36 [last day (36 w + 6 days)) weeks of pregnancy and at or after 42 weeks of pregnancy 7. Newborn Congenital disease detection after childbirth |
| Date of first enrolment | 01/10/2016 |
| Date of final enrolment | 01/06/2019 |
Locations
Countries of recruitment
- Ireland
- Italy
- Spain
- Switzerland
- United Kingdom
Study participating centres
Barcelona
08003
Spain
29603 Marbella
Málaga
29603
Spain
Valladolid
47012
Spain
La Vila Joiosa
Alicante
03570
Spain
Sponsor information
Not defined
Carrer del Rosselló, 229
Barcelona
08008
Spain
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. A general report of all results will be made (end of 2019) 2. Congress contributions (poster and communications) 3. Al least one paper will be submitted to an international journal during 2019 (preferably Q1 Journal) |
| IPD sharing plan | Please contact ; Dr. Ramón Escuriet (rescuriet@me.com) or Catalonia Council of Nurses (consell@codinf.org) for access |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/10/2016 | 21/10/2016 | No | Yes | |
| Results article | results | 01/03/2019 | 12/02/2021 | Yes | No |
| Results article | Oxytocin Administration in Low-Risk Women, a Retrospective Analysis of Birth and Neonatal Outcomes | 20/04/2021 | 18/11/2024 | Yes | No |
Additional files
- ISRCTN17833269_PIS_19Oct2016_Spanish.docx
- - uploaded 21/10/2016
Editorial Notes
18/11/2024: Publication reference added.
12/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
21/10/2016: Recruitment start date was changed from 01/11/2016 to 01/10/2016. Participant information sheet uploaded.
