Perinatal death Severe perinatal morbidity IUGR - Intra Uterine Growth Restriction SGA - Small for Gestational Age
Conditions
Interventions
In all midwifery practices, growth will be monitored using standardised symphysis fundal height (SFH) measurement. In the intervention strategy two routine US examinations will be performed (between 2
Sponsors
VU University Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria MIDWIFERY PRACTICES: 1) midwives have received the post registration training on the new KNOV guideline ‘detection of IUGR’; 2) those who will perform the biometry US have passed tests on quality fetal US. Inclusion criteria PREGNANT WOMEN: 1) negative 20 week US screening test result; 2) singleton pregnancy; 3) receiving care in primary care at 22 weeks gestation.
Exclusion criteria
Exclusion criteria: Exclusion criteria PREGNANT WOMEN: Women without dating US who do not have a reliable estimated date of delivery (EDD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical primary outcome is a dichotomous composite measure ‘severe adverse perinatal outcome’ up to 7 days after birth, including: perinatal death; Apgar score below 4 at 5 minutes after birth; impaired consciousness; asphyxia; neonatal seizures; need for assisted ventilation for more than 24 hours; septicaemia; meningitis; bronchopulmonary dysplasia; intraventricular haemorrhage; cystic periventricular leukomalacia; or necrotizing enterocolitis. Also direct and indirect costs are primary outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| COMPOSITE secondary outcomes 1. Spontaneous vaginal birth without intervention, i.e. a birth without any of the following: - induction of labour other than amniotomy - vacuum/ forceps - caesarean section - augmentation of labour - pharmacological pain relief: epidural anaesthesia or use of opioids 2. Maternal morbidity, defined as the presence of one or more of the following: - maternal death within 42 days after giving birth - hypertension - pre-eclampsia - postpartum haemorrhage - third or fourth degree perineal trauma SINGULAR secondary outcomes: - elements of composite primary outcome - elements of the two composite secondary outcomes - birth weight - gestational age at birth - neonatal mortality and severe morbidity between 7th and 28th day after birth - detection of congenital abnormalities - home and hospital birth in primary care - non-cephalic presentations (when labour started) in primary care - general quality of life - EQ-5D-5L - pregnancy specific anxiety - PRAQ - depression - EPDS - maternal-fetal attachment - MAAS - client satisfaction - subscale of PCQ | — |
Contacts
Public Contactirisstudie@vumc.nl
Outcome results
None listed