Pregnancy outcome prediction study 2

The evaluation and development of novel diagnostic methods to understand and prevent placentally-related complications of human pregnancy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12181427

Enrollment

13664

Registered

2019-10-07

Start date

2020-01-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia and fetal growth restriction Pregnancy and Childbirth Pre-eclampsia and fetal growth restriction

Interventions

Women will be recruited at their dating ultrasound scan, typically performed ~12wkGA. Blood will be obtained at this visit, at their anomaly scan (20wkGA), and at two research appointments (28wkGA and

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Nulliparous (no previous births >23wkGA) 2. Single viable fetus at the dating ultrasound scan with an ultrasonic estimated gestational age <18wkGA

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
The primary outcome is a composite, namely, one or more of the following: 1. Diagnosis of preeclampsia (using the ACOG 2013 definition), 2. Perinatal death or perinatal morbidity, or 3. Delivery of an infant with a birth weight 10mmol/L) or admission to the neonatal unit (defined as admission 12mmol/L.	—

Secondary

Measure	Time frame
Secondary outcomes will include each of the individual elements of the maternal and perinatal composite described above. The following additional secondary outcomes will be studied: 1. Maternal: 1.1 Maternal death 1.2 Maternal stroke 1.3 Maternal admission to any medical unit (e.g. intensive care unit, stroke unit, coronary care unit, neurosciences critical care unit) 1.4 Placental abruption 1.5 Cord prolapse 1.6 Caesarean section 1.7 Epidural anaesthesia 1.8 Instrumental vaginal delivery 1.9 General anaesthesia 1.10 Post-partum haemorrhage (any >500ml) 1.11 Post-partum haemorrhage requiring blood transfusion 1.12 Infection (pyrexia >38°C and treated with a course of antibiotics) Maternal death, stroke, admission to a medical unit, hemorrhage and infection will include all episodes occurring prior to discharge home following the delivery. 2. Perinatal: 2.1 Apgar at 1 minute 2.2 Apgar at 5 minutes 2.3 Apgar at 10 minutes 2.4 Umbilical arterial pH and base deficit 2.5 Umbilical vein pH and base deficit 2.6 Any/duration of admission to Special Care 2.7 Any/duration of admission to Neonatal Intensive Care 2.8 Fracture (any) 2.9 Seizures (any) 2.10 Prolonged hypotonia (>2h) 2.11 Abnormal level of consciousness (hyperalert, drowsy, lethargic, stupor, decreased response to pain, coma) 2.12 Tube feeding (any duration) 2.13 Head cooling 2.14 Phototherapy 2.15 Severe hypoglycemia (defined as requiring parenteral treatment or drug therapy)	—

Measure

Time frame

Secondary outcomes will include each of the individual elements of the maternal and perinatal composite described above. The following additional secondary outcomes will be studied: 1. Maternal: 1.1 Maternal death 1.2 Maternal stroke 1.3 Maternal admission to any medical unit (e.g. intensive care unit, stroke unit, coronary care unit, neurosciences critical care unit) 1.4 Placental abruption 1.5 Cord prolapse 1.6 Caesarean section 1.7 Epidural anaesthesia 1.8 Instrumental vaginal delivery 1.9 General anaesthesia 1.10 Post-partum haemorrhage (any >500ml) 1.11 Post-partum haemorrhage requiring blood transfusion 1.12 Infection (pyrexia >38°C and treated with a course of antibiotics) Maternal death, stroke, admission to a medical unit, hemorrhage and infection will include all episodes occurring prior to discharge home following the delivery. 2. Perinatal: 2.1 Apgar at 1 minute 2.2 Apgar at 5 minutes 2.3 Apgar at 10 minutes 2.4 Umbilical arterial pH and base deficit 2.5 Umbilical vein pH and base deficit 2.6 Any/duration of admission to Special Care 2.7 Any/duration of admission to Neonatal Intensive Care 2.8 Fracture (any) 2.9 Seizures (any) 2.10 Prolonged hypotonia (>2h) 2.11 Abnormal level of consciousness (hyperalert, drowsy, lethargic, stupor, decreased response to pain, coma) 2.12 Tube feeding (any duration) 2.13 Head cooling 2.14 Phototherapy 2.15 Severe hypoglycemia (defined as requiring parenteral treatment or drug therapy)

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026