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"Nama, Naseeb"
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Efficacy of Oral Dydrogesterone in Improving Neonatal Birth Weight Outcomes in Idiopathic Intrauterine Growth Restriction: A Prospective Observational Study
2025
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.
Journal Article
Preoperative Sublingual Misoprostol for Intraoperative Blood Loss Reduction in Total Abdominal Hysterectomy: A Randomized Controlled Trial
2025
Background and objective Total abdominal hysterectomy represents one of the most frequently performed gynecological procedures globally, with intraoperative hemorrhage constituting a significant clinical concern impacting surgical outcomes and patient morbidity. Misoprostol, a synthetic prostaglandin E1 analog, demonstrates established uterotonic properties with potential hemostatic benefits in gynecological surgery. This randomized controlled trial aimed to evaluate the efficacy of a preoperative single sublingual dose of 400 μg misoprostol versus placebo in reducing mean operative blood loss during total abdominal hysterectomy among women undergoing elective procedures. Methodology This randomized controlled trial (Trial registration number: SPH0000567) was conducted at the Department of Obstetrics and Gynecology Unit-I, Sandeman Provincial Hospital, Quetta, from October 2015 to April 2016. The study enrolled 434 women aged 18-70 years undergoing elective total abdominal hysterectomy, randomly allocated into two groups using computer-generated randomization with sealed envelope concealment. Group A received a single sublingual folic acid tablet of 5 mg 30 minutes preoperatively, while Group B received a single sublingual misoprostol tablet of 400 μg 30 minutes before surgery. The primary outcome measure was mean operative blood loss, calculated through a comprehensive methodology incorporating suction chamber volume and gravimetric gauze weight measurement. Secondary endpoints included operative duration, postoperative hemoglobin drop, transfusion requirements, and adverse event profile. All surgical procedures were performed by a single surgical team, with blood loss measurement conducted by a single resident to eliminate inter-observer bias. Double-blinding was maintained, and outcome assessors were masked to treatment allocation. Results The study demonstrated a statistically significant reduction in mean operative blood loss in the misoprostol group compared to the placebo group, with values of 364.55±53.26 ml versus 422.65±56.77 ml, respectively, representing a mean difference of 58.1 ml (13.7%) reduction (p<0.001). Age-stratified analysis revealed consistent hemostatic efficacy across all demographic categories: 35-40 years group 361.97±56.25 ml versus 420.11±51.95 ml (p<0.001), 41-45 years group 367.43±43.05 ml versus 419.07±62.96 ml (p<0.001), and 46-50 years group 362.79±60.96 ml versus 426.67±53.26 ml (p<0.001). Parity-based subgroup analysis demonstrated universal statistical significance across nulliparous, primiparous, multiparous, and grand multiparous women. Secondary endpoints revealed significant reductions in postoperative hemoglobin drop, 1.85±0.42 g/dl versus 2.34±0.56 g/dl (p<0.001), and transfusion requirements, 8 patients (3.7%) versus 23 patients (10.6%) (p=0.003), representing a 65% relative risk reduction. Hospital length of stay was reduced to 2.8±0.6 days versus 3.1±0.7 days (p=0.012). Adverse events were predominantly gastrointestinal, with a higher incidence in the misoprostol group, but no serious complications were reported. Conclusion Preoperative sublingual misoprostol 400 μg administered 30 minutes before total abdominal hysterectomy significantly reduces intraoperative blood loss with an acceptable safety profile. The intervention demonstrates universal efficacy across age and parity subgroups, supporting routine clinical implementation for hemorrhage prevention in gynecological surgery.
Journal Article