Choudhary Chahat, Bandyopadhyay Arkapal, Bahadur Anupama, Chaturvedi Jaya, Handu Shailendra, Dhamija Puneet
Department of Pharmacology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
J Family Med Prim Care. 2021 Nov;10(11):4176-4181. doi: 10.4103/jfmpc.jfmpc_211_21. Epub 2021 Nov 29.
Safety of drug usage during pregnancy is of utmost importance. Unrestricted usage of drugs may lead to undesirable and unpredictable pregnancy outcomes. This study was designed to detect drug-related adverse pregnancy outcomes, perform prescription audit and develop a pregnancy drug registry.
A prospective observational study was conducted at a tertiary care hospital in northern India. Pregnant females attending antenatal clinic, irrespective of their duration of pregnancy were included in the study over a period of 1 year. The participants were followed up monthly during their pregnancy till the pregnancy outcome. Adverse pregnancy outcomes were evaluated and causality assessment was done using the WHO-UMC scale.
Descriptive and inferential statistical tools were used for appropriate variables. Regression model was used to establish relationship between factors proposed to be responsible for adverse pregnancy outcomes. Presence of adverse pregnancy outcome was used as an independent variable. Microsoft Excel and Strata (version 12) were used for statistical analysis.
A total 326 pregnant women were screened out of which 305 were included in the final analysis. Mean age of participants was 27.82 (±4.51) years. Pre-existing comorbidities were present in 4.26% of participants. Average number of drugs per participant was 6.32 (±1.94). Most drugs prescribed to participants were from FDA category B (49.23%) and category A (33.60%). Mean ADR reported per patient was 1.16 (±1.18) with involvement of musculoskeletal (56.42%) and gastrointestinal (7.16%) being most frequent. Adverse pregnancy outcomes were reported in 25 participants among which IUGR (24%) followed by IUD (20%) and ectopic pregnancy (16%) were most frequently observed. Multivariate logistic regression showed number of comorbidities ( = 0.037) and number of drugs consumed during pregnancy ( = 0.02) to be statistically significantly associated with occurrence of adverse pregnancy outcome.
Pregnancy registries have been instrumental in detection of signals for further research in drug-related adverse outcomes. Inappropriate usage of drugs has been shown to be associated with adverse pregnancy outcomes. Our study warrants need for further well-designed studies on adverse pregnancy outcomes in larger patient populations.
孕期用药安全至关重要。药物的无节制使用可能导致不良且不可预测的妊娠结局。本研究旨在检测与药物相关的不良妊娠结局，进行处方审核并建立妊娠药物登记册。
在印度北部的一家三级护理医院开展了一项前瞻性观察研究。在1年的时间里，纳入了到产前诊所就诊的怀孕女性，无论其孕周如何。参与者在孕期每月接受随访直至妊娠结局。评估不良妊娠结局并使用WHO-UMC量表进行因果关系评估。
对适当的变量使用描述性和推断性统计工具。使用回归模型建立拟认为对不良妊娠结局负责的因素之间的关系。将不良妊娠结局的存在作为自变量。使用Microsoft Excel和Strata（版本12）进行统计分析。
共筛查出326名孕妇，其中305名纳入最终分析。参与者的平均年龄为27.82（±4.51）岁。4.26%的参与者存在既往合并症。每位参与者的平均用药数量为6.32（±1.94）。给参与者开具的大多数药物来自FDA B类（49.23%）和A类（33.60%）。每位患者报告的平均药物不良反应为1.16（±1.18），其中肌肉骨骼系统（56.42%）和胃肠道（7.16%）受累最为常见。25名参与者报告了不良妊娠结局，其中最常观察到的是胎儿生长受限（24%），其次是宫内死亡（20%）和异位妊娠（16%）。多因素逻辑回归显示合并症数量（ = 0.037）和孕期用药数量（ = 0.02）与不良妊娠结局的发生在统计学上显著相关。
妊娠登记册有助于发现药物相关不良结局的进一步研究信号。已表明药物的不当使用与不良妊娠结局相关。我们的研究有必要对更大患者群体的不良妊娠结局开展进一步精心设计的研究。
