Delivery Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18-40 years with straightforward pregnancy 2. Labour starting spontaneously between 37 and 42 weeks 3. Single foetus in cephalic presentation 4. Labour assisted by midwives
Exclusion criteria
Exclusion criteria: 1. Women with diseases or medical conditions that could influence birth outcomes 2. Women with serious complications in previous pregnancies 3. Women without antenatal care 4. Women with a BMI higher than 35 kg/m2 5. Women planning hospital birth but delivering at home or while going to the hospital 6. Women planning childbirth in a freestanding birth centre 7. Women with premature rupture of membranes for more than 72 hours 8. Women with previous caesarean section 9. Women with prenatal congenital malformation diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: 1. Composite rate of neonatal death during labour and early neonatal death assessed using the ALPACC database with a 7 days follow-up time after the birth 2. Composite rate of maternal death during labour and early maternal death assessed using the ALPACC database with a 7 days follow-up time after the birth 3. Rate of postpartum haemorrhage measured after birth using the ALPACC database 4. Rate of perineal injury measured after birth using the ALPACC database 5. Rate of women admitted in intensive care unit after birth to 24 h postpartum using the ALPACC database. 6. Rate of neonates with neonatal encephalopathy measured 7 days after birth using the ALPACC database 7. Rate of neonates with Apgar score equal to 7 or lower, measured after birth using the ALPACC database. 8. Rate on neonates admitted into neonatal intensive care unit (NICU) from birth to 24 h after birth using the ALPACC database Phase 2: 1. Women’s perception of their own capacity during birth, assessed using the Childbirth Experience Questionnaire (CEQ-E), filled in between 30 days and 3 months after the birth 2. Women’s perception of the professional support during birth, assessed using the CEQ-E, filled in between 30 days and 3 months after the birth 3. Women’s perception of their safety during birth, assessed using the CEQ-E, filled in between 30 days and 3 months after the birth 4. Women’s perception of their participation during birth, assessed using the CEQ-E, filled in between 30 days and 3 months after the birth Phase 3: primary outcomes 1. Cost of labour and birth care measured using a questionnaire filled by midwives in the obstetric unit before discharge. 2. Human resources cost measured using a questionnaire filled by midwives in the obstetric unit before discharge 3. Material resources cost, measured using a questionnaire filled by midwives in the obstetric unit before discharge 4. Pain management cost, measured using a questionnaire filled by midwives in the obstetric un | — |
Countries
Spain