Preeclampsia, gestational hypertension, induction of labour Preeclampsie, zwangerschaps hypertensie, inleiden van de baring
Conditions
Interventions
Patients will be randomly allocated to induction of labour or to expectant management until 37 weeks gestation.
Sponsors
Dutch consortium for studies in obstetrics, gynaecology, fertility, neonatology, gynaecological oncology, and urogynaecology.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Maternal age > 18 years; 2. Gestational age 34+0 - 37+0; 3. Informed consent. Diagnosed with gestational hypertension: 1. 100 mmHg ≤ diastolic blood pressure 110mmHg) who reach a stable diastolic blood pressure of ≤ 110 mmHg after medication. Patients with chronic hypertension (diagnosed before 20 weeks of pregnancy): 1. Who develop preeclampsia between 34 and 37 weeks of pregnancy; 2. Who have the need for additional medication after 34 weeks. Diagnosed with pre-eclampsia: 1. Diastolic blood pressure ≥ 90 mmHg ¡Ü (at two occasions at least six hours apart); 2. 0,3 g ≤ proteinuria 30.
Exclusion criteria
Exclusion criteria: 1. Diastolic blood pressure equal/greater than 110 mmHg despite medication; 2. Systolic blood pressure equal/greater than 170 mmHg despite medication; 3. Proteinuria equal/greater than 5 g/L; 4. Renal disease; 5. Heart disease; 6. Seropositive for HIV; 7. Eclampsia; 8. HELLP syndrome; 9. Pulmonary edema or cyanosis; 10. Oliguria less than 500 mL in 24 hours; 11. Non-reassuring fetal heart rate; 12. Ruptured membranes; 13. Fetal abnormalities including abnormal karyotype; 14. Severe preeclamptic complaints, such as frontal headache.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are for the mother a composite endpoint of maternal mortality, maternal complications (eclampsia, HELLP syndrome, pulmonary edema), thrombo-embolic disease and placental abruption. The neonatal primary outcome measure is respiratory distress syndrome (RDS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary maternal outcomes will be caesarean section rate, instrumental vaginal delivery rate, maternal quality of life and quality of recovery and costs. Secondary neonatal outcome will be neonatal morbidity defined as neonatal infection or sepsis, intravenous therapy needed hypoglycaemia, wet lung syndrome, meconium aspiration syndrome, pneumothorax and/or pneumomediastinum, periventricular leucomalacia, convulsions and other neurological abnormalities necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH) or asphyxia. Adverse neonatal outcome will be defined as a 5-minute Apgar score below 7 and an umbilical artery pH below 7.05 or admission to neonatal intensive care. | — |
Contacts
Public ContactJ. Langenveld
P.Debeyeplein 25 Postbus 5800
Outcome results
None listed