Effect of nitric oxide donor and plasma volume expansion on pregnancies with early onset fetal growth restriction: a randomized controlled trial
Abstract
Purpose: To evaluate the effect of nitric oxide (NO) donor, in combination with plasma volume expansion, on both fetal and maternal outcomes in pregnancies complicated by early-onset fetal growth restriction (FGR).
Methods: A total of 40 pregnant women diagnosed with early onset FGR were recruited from Ain Shams University Maternity Hospital between June 2023 to December 2023. The patients were randomly assigned into two groups, 20 in each group. Group A received Nitroderm TTS ® 5 mg for 12 h daily with plasma volume expansion (PVE) in the form of 2.5 L of water per day. Group B represented the control group. The primary endpoint of the study, assessed after 2 weeks of treatment initiation, focused on fetal growth parameters as the primary outcome. In addition, amniotic fluid volume, umbilical artery Doppler changes, development of fetal complications, maternal vital signs, and any side effects, were recorded. At the time of delivery, the following also documented: timing, mode, and interval to delivery, along with neonatal outcomes.
Results: Group A exhibit statistically significant enhancement in fetal growth compared to Group B in terms of estimated fetal weight, abdominal circumference, head circumference, biparietal diameter, femur length, amniotic fluid volume, and umbilical artery pulsatility index. Furthermore, Group A demonstrated more favorable outcomes in terms of gestational age at delivery, interval to delivery, birth weight, APGAR score and rates of NICU…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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