Efficacy of Oral Dydrogesterone in Improving Neonatal Birth Weight Outcomes in Idiopathic Intrauterine Growth Restriction: A Prospective Observational Study.

Background and objective Intrauterine growth restriction (IUGR) represents a significant obstetric complication with substantial global prevalence, with idiopathic cases constituting a considerable proportion where conventional therapeutic interventions demonstrate limited efficacy. Progesterone analogues have emerged as potential therapeutic agents for managing pregnancy-related complications, though evidence regarding their specific application in idiopathic IUGR remains limited. This prospective observational study aimed to evaluate the efficacy of oral dydrogesterone supplementation in improving neonatal birth weight outcomes among pregnant women diagnosed with idiopathic IUGR compared to conventional treatment modalities. Methodology A prospective observational study was conducted at the Department of Obstetrics and Gynecology, Sandeman Provincial Hospital, Quetta, over a six-month period from October 16, 2015, to April 15, 2016. The study enrolled 46 pregnant women aged 18-35 years with singleton pregnancies presenting at 28-34 weeks of gestation and diagnosed with idiopathic IUGR. Participants were allocated into two groups using a lottery method: Group A received conventional treatment comprising iron, folic acid supplementation, complete bed rest, and a high-protein diet, while Group B received identical conventional treatment plus oral dydrogesterone 10 mg twice daily for a minimum of four weeks or until delivery. The primary outcome measure was neonatal birth weight assessed within the first hour of delivery by trained nursing staff using calibrated scales. Results The study demonstrated statistically significant improvement in mean neonatal birth weight in the dydrogesterone group compared to conventional treatment, with mean birth weights of 2.10±0.19 kg versus 1.60±0.22 kg, respectively, representing a clinically meaningful difference of 0.50 kg with p<0.001. The dydrogesterone intervention achieved a 31.3% relative increase in birth weight outcomes. Subgroup analysis revealed consistent therapeutic benefits across all demographic stratifications, including age groups 18-23 years (2.08±0.21 kg versus 1.60±0.29 kg, p=0.016), 24-29 years (2.06±0.16 kg versus 1.64±0.22 kg, p<0.001), and 30-35 years (2.18±0.23 kg versus 1.62±0.20 kg, p<0.001). Parity analysis demonstrated significant improvements in primiparous (2.06±0.18 kg versus 1.65±0.23 kg, p<0.001), multiparous (2.15±0.23 kg versus 1.61±0.20 kg, p<0.001), and grand multiparous participants (2.15±0.07 kg versus 1.60±0.14 kg, p=0.039). Treatment success rate, defined as achieving a birth weight greater than 2.0 kg, was 91.3% (n=21) in the dydrogesterone group compared to 13.0% (n=3) in conventional treatment (p<0.001). Safety analysis revealed excellent tolerability with minimal adverse events reported in 8.7% (n=2) of dydrogesterone recipients. Conclusion Oral dydrogesterone supplementation demonstrates significant therapeutic efficacy in improving neonatal birth weight outcomes in idiopathic IUGR with an excellent safety profile. The substantial birth weight improvement of 0.50 kg supports potential integration into evidence-based clinical protocols for this challenging obstetric condition, warranting further large-scale randomized controlled trials for definitive clinical validation.