DM199 for Pregnancy Complications

Launched by DIAMEDICA THERAPEUTICS INC · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DM199, which aims to help women with pregnancy complications like preeclampsia and fetal growth restriction (FGR). Preeclampsia is a condition that can cause high blood pressure in pregnant women and can harm both the mother and baby. DM199 has shown promise in early studies by potentially lowering blood pressure, improving blood flow in the placenta, and being safe for both mother and baby. The trial will carefully test different doses of DM199 to find the most effective amount for women experiencing these complications.

To be eligible for the trial, women must be diagnosed with preeclampsia and/or FGR, be between 27 and 42 weeks pregnant, and have a single healthy baby. They should also be admitted to the hospital for care. However, certain serious conditions, like severe preeclampsia complications or significant heart problems, may disqualify them from participating. Women who join the trial can expect to receive the new treatment while being closely monitored by healthcare professionals. This research is important as it could lead to better management of pregnancy complications and improved outcomes for mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • A diagnosis of preeclampsia and/or fetal growth restriction
• • Gestational age between 27 weeks 0 days and 42weeks 0 days
• • Viable singleton pregnancy
• • Admitted for inpatient hospital management
• Exclusion Criteria:
• • Severe complications of preeclampsia which include;
• • Eclampsia
• • Pulmonary edema
• • HELLP syndrome
• • Severe renal involvement
• • Cerebrovascular event is defined as an ischemic or hemorrhagic stroke associated with clinical symptoms and definitive signs on imaging and or a liver hematoma or rupture.
• • Placental abruption
• • Clinical infection e.g.. 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 e.g.. 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 necessitate surgent 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