Assessment of Adequacy of Informed Consent Process before Caesarean Section: A Cross-sectional Study

Introduction: Caesarean section is the most common surgery performed in obstetrics. Legitimate informed consent should be obtained from the patient or her guardian before a caesarean section. Aim: To assess the adequacy of the informed consent process and to understand the reasons for any inadequacy in obtaining informed consent. Materials and Methods: A cross-sectional study was conducted in the Department of Obstetrics and Gynaecology at Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India from January 2022 to December 2022. The study included all patients undergoing caesarean sections. A total of 460 patients were included after obtaining prior legitimate consent. A pretested and pre-validated questionnaire was adopted for the study, consisting of 16 questions related to details of the informed consent process for the surgery performed and the anaesthesia. The responses were recorded on a five-point Likert scale. Responses of “strongly agree” (1) and “agree” (2) were considered adequate, while responses of “neutral” (3), “disagree” (4), and “strongly disagree” (5) were regarded as inadequate. Data from the questionnaires were collected and entered into a Microsoft Excel sheet and analysed using Statistical Packages of Social Sciences (SPSS) software. Results: Out of 460 patients, 242 (52.6%) were aged 18 to 25 years. Most of the women, 424 (92.2%), were literate. Additionally, 263 (57.2%) had undergone repeat caesarean sections, and 364 (79.1%) had emergency caesarean sections. A majority of the women, 414 (90%), were aware of the benefits of caesarean sections, and 394 (85.7%) were informed about the major risks involved in the surgery. Most respondents, 395 (85.9%), also received information regarding possible complications during their surgery. Information about the need for blood transfusion was provided to most respondents, 402 (87.4%). Furthermore, 388 (84.3%) of them were aware of the type of anaesthesia, but only a few patients, 27 (5.9%), were explained about the risks associated with anaesthesia. The effect of caesarean section on future pregnancy was not explained to 368 (80%) of the respondents. Conclusion: Although most patients were well informed about the procedure and the associated risks and complications, some elements of the consent process were inadequately addressed, indicating a need for improvement.