Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
- Conditions
- Circulatory SystemPregnancy and ChildbirthHypertensive disorders in pregnancy, pregnancy-induced hypertension, preeclampsia
- Registration Number
- PACTR201311000700893
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 440
<16 weeks of gestation and over 18 years of age,
- Intention to have subsequent antenatal visits and delivery at the same clinic.
- Can receive text messages by phone or through the phone of a proxy.
- A moderate to high risk (>20%) of developing PIH
- Pre-existing hypertension or hypertension before 20 weeks gestation.
- Likely non-compliance with the protocol in view of the treating physician
- Comorbidity interfering with the protocol
- Known contraindications to Investigational Product components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pregnancy-induced hypertension
- Secondary Outcome Measures
Name Time Method eonatal and infant outcomes: preterm birth, Intra uterine death, stillbirth, neonatal mortality, congenitial abnormality, NICU admission or pediatrician referral, birth weight, small for gestational age, apgar scores, other adverse effects. Infant outcomes: weight and hight, health, occurrence of disease and general health status. ;Tertiary: uptake and tolerability;Maternal/obstetric outcomes: maternal death, preeclampsia, eclampsia, HELLP syndrome, hemorrhage, saesarian section, other complications during pregnancy or delivery