Abstract :
Background: Preterm labor (PTL), defined as labor occurring between 20 to 37 weeks of gestation, is one of the primaryetiological factors for neonatal diseaseburden and fatality. This study assessed the effectiveness and safety of isoxsuprine, a tocolytic agent, in women experiencing PTL.Materials and Methods: Pregnant women (n=170) were treated at onset of PTL with isoxsuprine hydrochloride intravenous infusion (four 2-mL ampoules diluted in 500 mL of 5% w/v dextrose/Ringer lactate; drip rate of 8 drops per minute, increased by 8 drops per minute every 15 minutes), until uterinequiescence was achieved. This was followed by oral isoxsuprine therapy(40 mg twice daily) for up to 48 hours.Results: Successful tocolysis was achieved in 166 (97.6%) women at 24 hours and in 165 (97.1%) women at 48 hours, after the start of therapy (primary endpoint). Ten adverse drug reactions (ADRs) were reported in 10 (5.9%) women; four were classified as serious (fetal distress syndrome [n=2], stillbirths [n=2]); all were considered unlikely to be related to the study drug. No action was taken with the study medication in response to any of the ADRs. No clinically significant abnormalities like tachycardia or hypotension were reported duringvital sign monitoring every 4 hours from baseline to 48 hours. Delivery outcomes data were available for 146 (85.9%) women. All of them had delivered healthy babies with no congenital abnormalities (mean ± standard deviation birth weight: 2.7±0.43 kg).Conclusion: Isoxsuprine was effectiveand well-tolerated in the treatment of PTL, with acceptable maternal and perinatal outcomes.Clinical Trial Registration Number: CTRI/2020/01/022643, registered at www.ctri.nic.in.
Keyword :
Effectiveness, Isoxsuprine hydrochloride, Observational study, Preterm labor, Prospective, Safety, Tocolysis.