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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38165

Enrollment

680

Registered

2008-11-25

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-eclampsia toxemia

Interventions

Induction of labour, if necessary preceded by artificial cervical ripening versus expectant monitoring.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary outcomes will be neonatal morbidity due to prematurity, caesarean section rate, instrumental vaginal delivery rate, maternal quality of life and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)