Pregnant women with perceived reduced fetal movements at term. Pregnancy and Childbirth
Conditions
Interventions
Hospitals will be randomized into either the ‘revealed CPR’ arm or either the ‘concealed CPR’ arm. Hospitals are randomized using a computer-generated algorithm (in Castor), stratified by country and
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Singleton pregnancy with reported reduced fetal movements 2. Gestational age from 37+0 up to and including 40+6 weeks 3. Cephalic presentation 4. Normal cardiotocograph
Exclusion criteria
Exclusion criteria: 1. Maternal age <18 years 2. Inability to give informed consent 3. Small for gestational age (SGA) 4. Major congenital malformations or chromosomal abnormalities (that can influence pregnancy outcomes chosen for this study) 5. Indication for delivery within 4 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite of severe neonatal outcomes collected from medical files after delivery consisting of: 1. Stillbirth 2. Neonatal mortality 3. Apgar score 4 days)) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mild and other neonatal outcomes (including hypoglycaemia, hypothermia and admittance to the neonatal ward) will be collected from medical files after delivery. 2. Child development and behaviour will be assessed using the validated Ages and Stages Questionnaire (ASQ-3) and Child Behaviour Checklist (CBCL/1.5–5) at 24 months postpartum. 3. Maternal health-related quality of life will be measured using the validated European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire at baseline, six weeks postpartum, 12 months postpartum and 24 months postpartum. 4. Maternal fear of childbirth is assessed using the validated Wijma Delivery Expectancy Questionnaire (WDEQ-A) at baseline. 5. Maternal experience of childbirth is assessed using the validated Wijma Delivery Experience Questionnaire (WDEQ-B) and posttraumatic stress disorder checklist for DSM-5 (PCL-5) at six weeks postpartum. 4. Analysis of maternal serum markers (PlGF, sFLt-1, and PlGF/sFLt-1 ratio) in the context of normal and abnormal CPR and in relation to (adverse) outcomes and baseline characteristics will be performed in a post-hoc analysis. The single maternal blood sample will be taken at baseline. 5. Whenever possible placentas will be stored to determine the accuracy of routine placental immunohistochemistry in a post-hoc analysis. 6. A cost-effectiveness analysis of monitoring-intervention strategy will be performed. A short-term and long-term cost-effectiveness analysis from a societal perspective will be performed as well as a budget impact analysis. | — |
Countries
Australia, England, Netherlands, United Kingdom
Outcome results
None listed