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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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22 February 2021 |
Main ID: |
ISRCTN17833269 |
Date of registration:
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19/10/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Midwives’ contribution to normal childbirth care. Cross-sectional study in public health settings
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Scientific title:
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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)
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Date of first enrolment:
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01/10/2016 |
Target sample size:
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1500 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN17833269 |
Study type:
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Observational |
Study design:
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Prospective multicentre and cross-sectional study (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Ireland
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Italy
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ramón
Escuriet |
Address:
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Doctor Aiguader, 80, 3ª Planta (Despatx 61.311)
08003
Barcelona
Spain |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Childbirth Pregnancy and Childbirth
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Intervention(s)
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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
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Primary Outcome(s)
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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 .
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Secondary Outcome(s)
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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
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Secondary ID(s)
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2016/6785/I
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Source(s) of Monetary Support
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Catalonia Council of Nurses
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committees of Clinical Research (Comité de Ética de Investigación Clínica del Parc Salut Mar), 25/05/2016, ref: 2016/6785/I
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/12/2019 |
URL:
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