ABSTRACT
Background: Intrauterine growth restriction (IUGR) is one of the major reasons for neonatal morbidity and mortality. Oligohydramnios is a common finding in IUGR. In majority of these cases diminished utero-placental blood flow is observed. However, in spite of this understanding and identification of high-risk patients, the management options are limited. Sildenafil citrate, a phosphodiesterase type-5 inhibitor improves utero-placental perfusion.Methods: We present a retrospective interventional study involving 50 adult pregnant women diagnosed with early-onset IUGR (n=38) and oligohydramnios (n=12). Vaginal sildenafil citrate 25 mg t.i.d. was started from the day of diagnosis till delivery. Primary efficacy endpoints included changes in Doppler parameters i.e., amniotic fluid index (AFI), uterine artery (UA)- pulsatility index (PI), resistance index (RI) and systolic diastolic ratio (S/D ratio). Secondary endpoints included live birth, birth weight, Apgar score at birth, neonatal survival to hospital discharge and adverse maternal side effects.Results: There was a statistically significant improvement in UA-PI, RI and S/D ratios (p<0.0001) in all cases. In oligohydramnios cases, treatment showed a statistical significant increase in AFI score (2.86±1.33 cm). The mean birth weight on delivery was 2200 gm with good Apgar scores. No major adverse effects were reported by women using sildenafil citrate vaginally.Conclusions: Sildenafil citrate, by increasing utero-placental perfusion, improves uterine artery Doppler patterns, AFI, fetal weight and overall better neonatal survival rates by reducing neonatal morbidity and mortality. Sildenafil citrate may hold a promising treatment strategy for management of IUGR and oligohydramnios.
ABSTRACT
Background: Supplementation of vitamin D2 or vitamin D3 is recommended for vitamin D deficiency. Weekly supplementation of 60,000 IU of vitamin D3 increases serum 25(OH) D to optimal values. Various marketed forms of vitamin D3 include tablets, capsule, granules and oral solution. The main objective of this study is to compare the relative bioavailability of vitamin D3 oral solution with vitamin D3 tablet and capsule.Methods: This is an open-label, randomized, single-dose, three-treatment study to compare the relative bioavailability of vitamin D3 oral solution with capsule and tablet. Subjects (n=70) were supplemented with single dose of one of these formulations and their blood sample were assessed for Cmax, AUC0-28d and Tmax.Results: The logarithmic transformed data of pharmacokinetic parameters were analyzed for 90% Confidence Intervals (CI) using ANOVA. The mean (90% CI) values of vitamin D3 oral solution against tablet for the ratio of Cmax and AUC0-28d were 113.00 (105.32-121.23) and 105.54 (97.95-113.72) respectively. The mean (90% CI) values of vitamin D3 oral solution against capsule for the ratio of Cmax and AUC0-28d were 115.02 (106.38 - 124.37) and 112.33 (104.44 - 120.81) respectively. These values were within the bioequivalence range of 80-125%.Conclusions: It is concluded that vitamin D3 Oral Solution formulated with nanotechnology is bioequivalent to vitamin D3 tablet and capsule. However, oral solution of vitamin D3 shows higher Cmax and AUC when compared to tablet and capsule formulations.