|- candidate number||5685|
|- NTR Number||NTR1792|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2009|
|- Secondary IDs||24278 ABR |
|- Public Title||HYPITAT-II|
|- Scientific Title||Hypertension and Preeclampsia Intervention Trial in the Almost Term patient. |
|- hypothesis||We hypothesize that induction of labour in patients with gestational hypertension, deteriorating chronic hypertension or preeclampsia between 34 and 37 weeks reduce the maternal morbidity but might increase the RDS rate in neonates, compared to expectant monitoring.|
|- Healt Condition(s) or Problem(s) studied||Pre-eclampsia, Gestational hypertension, Induction of labour|
|- 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 < 110 mmHg;
2. Patients (>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 < 5 g or 2 + proteinuria with dipstick or EKR > 30.
|- 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;
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2009|
|- planned closingdate||1-dec-2013|
|- Target number of participants||680|
|- Interventions||Patients will be randomly allocated to induction of labour or to expectant management until 37 weeks gestation.|
|- Primary outcome||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 outcome||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.
|- Timepoints||1. Maternal morbidity: short term outcome after delivery;|
2. Maternal quality of life: 6 months;
3. Respiratory distress syndrome: neonatal period.
|- Trial web site||www.studies-obsgyn.nl/hypitat2|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Langenveld |
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Porath|
|- Sponsor/Initiator ||Dutch consortium for studies in obstetrics, gynaecology, fertility, neonatology, gynaecological oncology, and urogynaecology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Gestational hypertension, deteriorating chronic hypertension and preeclampsia between 34 and 37 weeks: induction of labour versus expectant monitoring. A comparison of maternal and neonatal outcome, maternal quality of life and costs.
Multicentre randomised placebo-controlled trial. The study will be performed within a consortium nationwide including ten perinatal centres, which are collaborating in several studies.
Women with a gestational age between 34+0 and 37+0 weeks who are diagnosed with gestational hypertension, deteriorating chronic hypertension or preeclampsia.
|- Main changes (audit trail)||20-Jan-2013: Inaccuracy in the description of the composite of adverse maternal outcome. Instead of 'progression to severe preeclampsia', it includes 'thrombo-embolic disease and placental abruption' which are both described in the protocol approved by the METC. Also, a neonatal adverse outcome is added: 'admission to neonatal intensive care' - NM|
|- RECORD||2-mei-2009 - 10-mrt-2013|