Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Stellenbosch University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: A diagnosis of preeclampsia and/or fetal growth restriction Gestational age between 27 weeks 0 days and 42 weeks 0 days Viable singleton pregnancy Admitted for inpatient hospital management Viable singleton pregnancy
Exclusion criteria
Exclusion criteria: Severe complications of preeclampsia which include eclampsia, pulmonary edema, HELLP syndrome, severe renal involvement, cerebrovascular event is defined as an ischaemic or haemorrhagic stroke associated with clinical symptoms and definitive signs on imaging and or a liver haematoma or rupture Placental abruption Clinical infection eg. chorioamnionitis Underlying maternal cardiac disease including a significant arrhythmia, a conduction abnormality or severe valvular disease or congenital or acquired heart disease Significant maternal vascular disease eg. renal artery stenosis Patient is unable, or unwilling to give consent, or is under the age of 18. Suspicion or diagnosis of a major fetal anomaly or malformation or chromosomal abnormality. A major fetal anomaly is defined as anomalies or malformations that create significant medical problems for the neonate or that require specific surgical or medical management. Established fetal compromise that necessitates urgent delivery History of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization or familial angioedema Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening Women with an active malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 Incidence of treatment adverse events;Part 1 Umbilical cord blood levels of DM199 after birth;Part 1 Acute change in maternal blood pressure from baseline ;Part 2.1 Change in maternal blood pressure from baseline ;Part 2.1 Incidence of treatment emergent events;Part 2.1 Umbilical cord blood levels of DM199 after birth;Part 2.2 Prolongation of pregnancy;Part 2.2 Change in 24-hour protein creatinine ratio one week after enrolment, compared to baseline values;Part 2.2 Need to increase or decrease other antihypertensive agents;Part 2.2 Incidence of treatment emergent adverse events;Part 2.1 Umbilical cord blood levels of DM199 after birth;Part 2.3 Changes in uterine artery and ophthalmic artery Doppler flow indices;Part 2.3 Changes in fetal Doppler parameters;Part 2.3 Birthweight centile;Part 2.3 Incidence of treatment emergent adverse events;Part 2.3 Umbilical cord blood levels of DM199 after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 Maternal pharmacokinetic profile of DM199 in preeclampsia ;Part 1 Change in maternal blood pressure from baseline to delivery ;Part 1 Uterine contractions;Part 2.1 Uterine contractions;Part 2.1 Episodes of severe hypertension or hypotension after administration of DM199;Part 2.1 Use of other antihypertensive agents;Part 2.1 Changes in uterine and ophthalmic artery Doppler parameters;Part 2.2 Change in maternal blood pressure from baseline ;Part 2.2 Number of women reaching 34 weeks gestation;Part 2.2 Severe hypertension or hypotension;Part 2.2 Uterine contractions;Part 2.2 Changes in uterine artery, ophthalmic artery and fetal Doppler flow indices;Part 2.2 Neonatal length of stay at Tygerberg hospital and overall, in any hospital;Part 2.3 Prolongation of delivery;Part 2.3 Fetal growth trajectory ;Changes in maternal blood pressure;Part 2.3 Use of antihypertensive medication (if unmedicated at enrolment or the need to increase or decrease other antihypertensive agents | — |
Countries
South Africa
Contacts
Public ContactCatherine Cluver
Professor
Outcome results
None listed