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Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial

Not Applicable
Conditions
Circulatory System
Pregnancy and Childbirth
Hypertensive 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
Inclusion Criteria

<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

Exclusion Criteria

- 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
NameTimeMethod
Pregnancy-induced hypertension
Secondary Outcome Measures
NameTimeMethod
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
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