Hypertension in Pregnancy
Conditions
Keywords
Chronic hypertension in pregnancy, Pre-term delivery, Preeclampsia, Endothelial Health, Docosahexaenoic acid (DHA)
Brief summary
The Investigator would like to see if taking a DHA supplement at a dose recommended for heart health will improve brachial artery dilation (relaxation) and help blood pressure. As a second goal the Investigator would like to see if this supplement can delay preterm delivery by improving heart health. In this research study, the Investigator is asking pregnant women with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver their baby.
Detailed description
The Investigator will be supplementing pregnant mothers with Expecta. This is an over the counter supplement often used by pregnant and nursing mothers and will be given to expectant mothers during the research study. This DHA supplement is available to anyone at most any store. The dose often used over the counter is 200mg, we are testing the heart recommended dose of 1000mg. Because the Investigator is using the heart health recommended dose and because there may be a health claim, the Investigator is doing the study using an FDA- food and drug administration IND. IND means investigational drug. This dose has recently been used safely and effectively in pregnancy both here in the United States and in Australia in hundreds of women. There are no risks to the fetus as the placenta prefers to transfer this important nutrient for fetal eye and brain development. The large studies done in pregnancy have followed their babies into school age and found no adverse effects.
Interventions
DIETARY_SUPPLEMENTDocosahexaenoic acid 200 mg
Participants will be randomized to 200 mg docosahexaenoic acid daily (1-200mg capsule) PO beginning at 18-20 weeks gestation through 6 weeks post-partum.
DRUGDocosahexaenoic acid 1000 mg
Participants will be randomized to 1000 mg (5-200mg capsules) docosahexaenoic acid PO daily beginning at 18-20 weeks gestation through 6 weeks post-partum.
Sponsors
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women coming for their 19-20 week ultrasound for fetal anatomy and that have been diagnosed with hypertension by their Obstetrician will be eligible for inclusion.
Exclusion criteria
* Exclusions to enrollment will include: women \< 18 years old * Bleeding disorders * Lupus * Autoimmune diseases * The presence of infant congenital (trisomy 13,18, 21, urethral, gastrointestinal and cardiac defects)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improve maternal endothelial health | Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum | To test this hypothesis, the Investigator will undertake a RCT of 90 women with hypertension (chronic or newly diagnosed) in the second trimester of pregnancy, who will be randomized to 1000mg DHA or standard supplement and followed through to delivery with serial measures of blood pressure and vascular constriction by the Doppler method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improve immune homeostasis | Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum | Measured by decreased maternal blood and cord blood concentrations of pro-inflammatory cytokines IL-6, I L-8, TNF a, and receptor sRAGE. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decrease the number of infants born <34 weeks | Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum | In addition to the primary aims, we will examine evidence that DHA will prolong gestation |
Countries
United States
Outcome results
None listed