Gestational Hypertension, Preeclampsia and Eclampsia, Pregnancy Induced Hypertension
Conditions
Keywords
Pregnancy Induced Hypertension
Brief summary
The target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily L-citrulline supplementation or placebo.
Detailed description
Healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy will be eligible for this study. The purpose of this study will be to determine if daily supplementation of oral L-citrulline can reduce the incidence of pregnancy induced hypertension. This will be a double blind study, subjects will be randomized to receive either L-citrulline (3 gram sachet) or a placebo for a total of 8 weeks. Participants will be asked to provide urine and blood samples at time of enrollment, be asked to respond to a phone survey to assess for side effects, and again be asked to provide urine and blood samples at the end of 8 weeks. Participants will continue with routine prenatal care throughout the study.
Interventions
DRUGL-citrulline
3 gram sachet, L-citrulline
DRUGPlacebo
Milk powder placebo
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous (no previous pregnancy greater than 20 weeks) * Gestational age of pregnancy between 12 and 16 weeks
Exclusion criteria
* Known fetal anomaly or chromosomal abnormality * Early fetal growth restriction * Fetal demise or planned termination * Participation in another study that may influence this study * Known maternal kidney disease * Known maternal electrolyte imbalance * Known allergies to study interventions * Preexisting hypertension (chronic hypertension) * Known gastric ulcer * Incarcerated status * Planned delivery at non-UTMB hospital * Known lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pregnancy induced hypertension | To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization. | Incidence of pregnancy induced hypertension conditions (gestational hypertension, preeclampsia, or eclampsia) between treatment and placebo groups will be assessed by chart review after end of pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maternal nitric oxide levels with L-citrulline supplementation | Baseline at start of study and again after 8 weeks treatment | Assessment of change in nitric oxide levels between treatment and placebo groups by measurement of baseline and 8 week post treatment urine nitrate and nitrite concentrations |
| Maternal blood pressure | Baseline at start of study, and approximately every 1-4 weeks after randomization at prenatal appointments throughout pregnancy. Also at time of delivery approximately 8-9 months after randomization.. | Assessment of maternal blood pressure throughout study |
| Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration | Baseline at start of study and again after 8 weeks treatment | Assessment of change in serum L-citrulline and asymmetric dimethyl arginine (ADMA ) levels with L-citrulline administration between treatment and placebo groups. Serum samples will be collected at the beginning of study and after 8 weeks and assayed for ADMA and L-citrulline |
| Birth weight | To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization. | To assess the actual birthweight of neonate by chart review at time of delivery. This outcome is different than fetal growth restriction noted in outcome 5. |
| Neonatal Outcomes | To be assessed by chart review 8-9 months after enrollment at time of delivery | To determine the incidence of neonatal outcomes by chart review after delivery that include respiratory distress syndrome, necrotising enterocolitis, bronchopulmonary dysplasia (BPD), and BPD related pulmonary hypertension, retinopathy of prematurity, age at full feed, and length of hospital stay, fetal growth restriction defined as less than 10% of predicted gestational age, fetal death after 20 weeks gestation, and neonatal death |
| Maternal Morbidity | To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization. | Composite assessment of incidence of maternal outcomes to include development of preeclampsia; Hemolysis, Elevated liver enzymes, Low Platelets (HELLP) syndrome; eclampsia; indicated preterm birth less than 32 weeks due to hypertension related disorders |
Countries
United States
Outcome results
None listed