In view of the outcome of the HYPITAT study, one can raise the question how women with preeclampsia or severe hypertension between 34 and 37 weeks of gestation should be managed. Induction of labour might prevent maternal complications. However,…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be severe maternal and neonatal morbidity,
which can be complicated by maternal and neonatal mortality in rare cases.
Severe maternal morbidity will be defined as; eclampsia, HELLP syndrome,
pulmonary edema, trombo-embolic disease and/or placental abruption,
multi-organ-failure, admission to an intensive care unit. Severe neonatal
morbidity will be defined as IRDS.
Secondary outcome
Secondary outcomes will be neonatal morbidity due to prematurity, caesarean
section rate, instrumental vaginal delivery rate, maternal quality of life and
costs.
Background summary
10% to 15% of all pregnancies are complicated by hypertensive disorders, i.e.
gestational hypertension or preeclampsia (19.000 women per year in The
Netherlands). The large majority of these cases occur beyond 34 weeks of
pregnancy. There is no causal treatment but termination of pregnancy. In case
of pre-term pregnancies complicated by hypertension, conservative management is
advocated to as long as the risks for the mother are acceptable.
Recently, our group evaluated whether a policy of induction of labour in women
with mild preeclampsia or gestational hypertension was superior to a policy of
expectant management. We found that induction of labour reduced the number of
complications, such as severe hypertension, whereas there was no increase in
caesarean sections. Based on these data, we recommended induction of labour in
women with mild preeclampsia or hypertension at term.
Study objective
In view of the outcome of the HYPITAT study, one can raise the question how
women with preeclampsia or severe hypertension between 34 and 37 weeks of
gestation should be managed. Induction of labour might prevent maternal
complications. However, late preterm births are common and associated with
significantly increased neonatal mortality and morbidity compared with births
at 39 weeks. We aim to make a comparison of maternal and neonatal outcome,
maternal quality of life and costs.
Study design
Multicentre randomised controlled clinical trial.
Intervention
Induction of labour, if necessary preceded by artificial cervical ripening
versus expectant monitoring.
Study burden and risks
We think that the estimated burden and risk for the patient is low, while a
delivery will happen anyway in short time notice. The exact moment though will
be influenced.
PO Box 22700
1105 DE Amsterdam
NL
PO Box 22700
1105 DE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients 18 years of age or older which have gestational hypertension or pre-eclampsia at a gestational age between 34+0 and 37+0 weeks of gestation. A diagnosis of pregnancy induced hypertension is made in case the diastolic blood pressure is above 100 mmHg at two occasions at least six hours apart in a woman who was normotensive until at least 20 weeks of gestation. A diagnosis of preeclampsia is made in case the diastolic blood pressure is above 90 mmHg and there exists a proteinuria > 300 mg total protein in a 24 hour urine collection.
inclusion criteria:
- Maternal age * 18 years
- Gestational hypertension defined as:
o 100 mmHg < diastolic blood pressure < 110 mmHg
o at two occasions at least six hours apart
- Pre-eclampsia defined as:
o 90 mmHg * diastolic blood pressure < 110 mmHg
o at two occasions at least six hours apart
o 0,3 g * proteinuria < 10 g
o proteinuria > 300 mg total protein in an 24 hour urine collection
- Gestational age between 34+0 and 37+0 weeks
- Informed consent
- Women with singleton or multiple pregnancy
- Women with a child in cephalic or breech presentation
Exclusion criteria
* Diastolic blood pressure * 110 mmHg despite medication
* Systolic blood pressure * 170 mmHg despite medication
* Renal disease
* Heart disease
* Seropositive for HIV
* HELLP syndrome
* Pulmonary edema or cyanosis
* Proteinuria * 5 g/L
* Oliguria < 500 mL in 24 hours
* Non-reassuring foetal heart rate
* Foetal abnormalities including abnormal karyotype.
* Severe preeclamptic complaints, such as frontal headache
* Ruptured membranes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT1792 |
| CCMO | NL24278.018.08 |