HYPITAT-II
Completed
- Conditions
- Preeclampsia, gestational hypertension, induction of labourPreeclampsie, zwangerschaps hypertensie, inleiden van de baring
- Registration Number
- NL-OMON29619
- Lead Sponsor
- Dutch consortium for studies in obstetrics, gynaecology, fertility, neonatology, gynaecological oncology, and urogynaecology.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 680
Inclusion Criteria
1. Maternal age > 18 years;
2. Gestational age 34+0 - 37+0;
Exclusion Criteria
1. Diastolic blood pressure equal/greater than 110 mmHg despite medication;
2. Systolic blood pressure equal/greater than 170 mmHg despite medication;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures are for the mother a composite endpoint of<br>maternal mortality, maternal complications (eclampsia, HELLP syndrome, pulmonary edema), thrombo-embolic disease and placental abruption.<br /><br>The neonatal primary outcome measure is respiratory distress syndrome (RDS).<br>
- Secondary Outcome Measures
Name Time Method Secondary maternal outcomes will be caesarean section rate, instrumental vaginal delivery rate, maternal quality of life and quality of recovery and costs. <br /><br>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.