Condition category
Pregnancy and Childbirth
Date applied
14/10/2016
Date assigned
19/10/2016
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

www.llevadora.eu

Contact information

Type

Scientific

Primary contact

Dr Ramón Escuriet

ORCID ID

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

Contact details

Doctor Aiguader
80
3ª Planta (Despatx 61.311)
Barcelona
08003
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016/6785/I

Study information

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)

Acronym

MIDCONBIRTH II

Study hypothesis

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

Ethics Committees of Clinical Research (Comité de Ética de Investigación Clínica del Parc Salut Mar), 25/05/2016, ref: 2016/6785/I

Study design

Prospective multicentre and cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Community

Trial type

Other

Patient information sheet

See additional files

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/10/2016

Overall trial end date

01/12/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1500

Participant 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

Recruitment start date

01/10/2016

Recruitment end date

01/06/2019

Locations

Countries of recruitment

Ireland, Italy, Spain, Switzerland, United Kingdom

Trial participating centre

Hospital del Mar. Parc de Salut Mar
Doctor Aiguader, 80, 3ª Planta
Barcelona
08003
Spain

Trial participating centre

Hospital Costa del Sol de Málaga
Autovia A-7, Km 187 29603 Marbella
Málaga
29603
Spain

Trial participating centre

Hospital Rio Hortega de Valladolid
Calle Dulzaina, 2
Valladolid
47012
Spain

Trial participating centre

Hospital de La Marina Baixa de Villajoyosa
Avenida Alcalde En Jaume Botella Mayor, 7 La Vila Joiosa
Alicante
03570
Spain

Sponsor information

Organisation

Catalonia Council of Nurses

Sponsor details

Carrer del Rosselló
229
Barcelona
08008
Spain

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Catalonia Council of Nurses

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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

Intention to publish date

01/03/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/10/2016: Recruitment start date was changed from 01/11/2016 to 01/10/2016. Participant information sheet uploaded.