HYpertension and Preeclampsia Intervention Trial in the Almost Term Patient (HYPITAT-2)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 680

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be severe maternal and neonatal morbidity,<br /><br>which can be complicated by maternal and neonatal mortality in rare cases.<br /><br>Severe maternal morbidity will be defined as; eclampsia, HELLP syndrome,<br /><br>pulmonary edema, trombo-embolic disease and/or placental abruption,<br /><br>multi-organ-failure, admission to an intensive care unit. Severe neonatal<br /><br>morbidity will be defined as IRDS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be neonatal morbidity due to prematurity, caesarean<br /><br>section rate, instrumental vaginal delivery rate, maternal quality of life and<br /><br>costs. </p><br>