Karekar Sonali Rajiv, Pooja S G, Marathe Padmaja Anil
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Perspect Clin Res. 2020 Jan-Mar;11(1):8-12. doi: 10.4103/picr.PICR_157_18. Epub 2019 Apr 26.
Pregnant women undergo physiological changes which influence the efficacy as well as safety of medications used. Very few drugs are tested and approved for medical conditions during pregnancy, and less pharmacokinetic data are available to form clinical treatment guidelines. There was no data available regarding the type of research studies conducted in pregnancy in India. Hence, we conducted this study to analyze the type of research studies in pregnancy registered in the Clinical Trials Registry of India (CTRI).
Following exemption from review by the Institutional Ethics Committee, all studies in pregnant women registered in CTRI from its inception in July 2007 to June 2018 were reviewed. Data were captured with respect to geographical distribution, trimester of pregnancy, study designs used, therapy area, and funding.
The variables were analyzed using descriptive statistics using SPSS version 16.0.
Out of a total of 14,911 studies in CTRI, a total of 285 (1.91%) studies involved pregnant women. Of these studies, 199 (69.8%) were interventional, whereas 86 (30.1%) were observational. Of all the interventional studies, 119 (60%) tested drugs, 47 (24%) tested a nondrug intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and vaccines. Postgraduate theses constituted 140 (49.1%) studies, 79 (27.7%) were academic projects, 27 (9.4%) were government-funded studies, and only 16 (5.6%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was anesthesia, followed by hypertension and induction of labor.
This study depicts underrepresentation of pregnant women in clinical studies and more evidence needs to be generated with respect to drug safety and pharmacokinetics.
孕妇会经历生理变化，这会影响所用药物的疗效和安全性。在孕期针对医疗状况进行测试和获批的药物极少，且用于形成临床治疗指南的药代动力学数据也较少。关于印度孕期开展的研究类型，尚无可用数据。因此，我们开展了本研究，以分析在印度临床试验注册中心（CTRI）注册的孕期研究类型。
经机构伦理委员会批准豁免审查后，对CTRI自2007年7月成立至2018年6月期间注册的所有孕妇研究进行了审查。收集了有关地理分布、妊娠 trimester、所用研究设计、治疗领域和资金来源的数据。
使用SPSS 16.0版软件，对变量进行描述性统计分析。
在CTRI总共14911项研究中，共有285项（1.91%）研究涉及孕妇。在这些研究中，199项（69.8%）为干预性研究，而86项（30.1%）为观察性研究。在所有干预性研究中，119项（60%）测试药物，47项（24%）测试非药物干预措施，其余为营养保健品、阿育吠陀、瑜伽与自然疗法、尤那尼、悉达、顺势疗法以及疫苗。研究生论文构成140项（49.1%）研究，79项（27.7%）为学术项目，27项（9.4%）为政府资助研究，仅有16项（5.6%）为制药公司赞助研究。最常研究的治疗领域是麻醉，其次是高血压和引产。
本研究表明孕妇在临床研究中的代表性不足，需要就药物安全性和药代动力学生成更多证据。
