Study of the perception of reduced fetal movements
Not Applicable
- Conditions
- Pregnant women with perceived reduced fetal movements at term.Pregnancy and Childbirth
- Registration Number
- ISRCTN17329697
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33836690/ (added 28/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 2160
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is a composite of severe neonatal outcomes collected from medical files after delivery consisting of:<br>1. Stillbirth<br>2. Neonatal mortality<br>3. Apgar score < 7 at 5 min<br>4. pH < 7.10 (umbilical artery)<br>5. Emergency delivery for fetal distress (need for cooling, caesarean section or ventouse/forceps)<br>6. Severe neonatal morbidity (respiratory distress syndrome, hypoxic ischemic encephalopathy, sepsis, necrotizing enterocolitis and supplementary oxygen therapy (> 4 days))
- Secondary Outcome Measures
Name Time Method