Condition category
Pregnancy and Childbirth
Date applied
28/09/2015
Date assigned
11/12/2015
Last edited
11/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

www.llevadora.eu

Contact information

Type

Scientific

Primary contact

Mr Ramón Escuriet

ORCID ID

http://orcid.org/0000-0002-7277-3331

Contact details

Riera de Sant Miquel
61. 1
Barcelona
08006
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

MIDwives CONtribution to childbirth care provision versus other health professionals childbirth care provision and BIRTH outcomes in public hospitals in Catalonia

Acronym

MIDCONBIRTH

Study hypothesis

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

Comité Ético de Investigación Clínica del Consorci Sanitari Integral, 16/12/2015, ref: 15/74

Study design

Prospective multi-centre cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Percentage of low risk births attended to by midwives in public hospitals in Catalonia during the study period.

Secondary outcome measures

Outcomes of births attended to by midwives, measured using Bologna Score within 24 hours after birth and before discharge from maternity ward.

Overall trial start date

18/09/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Total recruitment: 1434

Participant exclusion criteria

1. High or very high risk during pregnancy
2. Newborn Congenital disease detection after childbirth

Recruitment start date

01/12/2015

Recruitment end date

01/06/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital General de l’Hospitalet
Av. Josep Molins, 29-41 L'Hospitalet De Llobregat
Barcelona
08906
Spain

Trial participating centre

Hospital Parc Taulí de Sabadell
Parc Taulí, 1 Sabadell
Barcelona
08208
Spain

Trial participating centre

Hospital Sant Joan de Déu de Manresa
Manresa
Barcelona
08243
Spain

Trial participating centre

Fundació Hospital Sant Joan de Déu de Martorell
Av. Mancomunitat Comarcals, 1-3 Martorell
Barcelona
08760
Spain

Sponsor information

Organisation

Catalonia Nurses Colleges Council (Consell de Col·legis d'Infermeres i Infermers de Catalunya)

Sponsor details

Carrer Rosselló
229
Barcelona
08008
Spain

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Catalonia Nurses Colleges Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. A general report with all relevant results will be elaborated
2. Congress contributions (poster and communications)
3. At least one paper will be submitted to an international journal (preferably Q1 Journal)

Intention to publish date

30/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/01/2015: Ethical approval updated and Fundació Hospital Sant Joan de Déu de Martorell added as a trial participating centre.