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…
ID
Bron
Verkorte titel
Aandoening
Preeclampsia, gestational hypertension, induction of labour
Preeclampsie, zwangerschaps hypertensie, inleiden van de baring
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.<br>
The neonatal primary outcome measure is respiratory distress syndrome (RDS).
Achtergrond van het onderzoek
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.
Study design:
Multicentre randomised placebo-controlled trial. The study will be performed within a consortium nationwide including ten perinatal centres, which are collaborating in several studies.
Study population:
Women with a gestational age between 34+0 and 37+0 weeks who are diagnosed with gestational hypertension, deteriorating chronic hypertension or preeclampsia.
Doel van het onderzoek
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.
Onderzoeksopzet
1. Maternal morbidity: short term outcome after delivery;
2. Maternal quality of life: 6 months;
3. Respiratory distress syndrome: neonatal period.
Onderzoeksproduct en/of interventie
Patients will be randomly allocated to induction of labour or to expectant management until 37 weeks gestation.
Publiek
Postbus 5800
J. Langenveld
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
Josje_langenveld@hotmail.com
Wetenschappelijk
Postbus 5800
J. Langenveld
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3876543
Josje_langenveld@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1691 |
| NTR-old | NTR1792 |
| Ander register | ABR : 24278 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |