Informed consent (IC) consists of availing information to the patient in an understandable manner without coercion to allow the patient to make an informed decision about their health care. The decision of performing a cesarean section must be followed by a legitimate IC from the patient or her guardian. IC is an ethical and legal requirement. The rate of cesarean sections has increased many times due to various reasons, all in good faith of the patient, however, it does not escape the purview of consumer awareness and protection.
It is not clear to what extent the current consenting practice at our institute offers the patients regarding their opportunity to make a good judgment. This study aims to audit and assess the understanding of information obtained by patients undergoing cesarean section and their involvement in the consenting process. Hence, we aimed to provide insight into the sufficiency of the consenting process for cesarean sections and the level of patients’ understanding and adequacy of an IC for cesarean sections.
Materials and Methods
It was a cross-sectional study conducted in the postoperative ward of the obstetrics department of a tertiary care institute in Mangalore from July 2016 to July 2017. After obtaining ethical clearance, a questionnaire was designed including several aspects of awareness of IC, and was given to 150 postcesarean patients. The questionnaire was then evaluated, and an inference was drawn based on the patients’ answers. The data were entered into the Microsoft Excel sheet and were analyzed using the SPSS software. The adequacy of IC was assessed on the basis of their reply (i.e., strongly agree/agree) to these statements, i.e., name of the procedure, nature of the procedure, and indications of the procedure. The Chi-square test was used, and the P value was calculated.
The demographic distribution of the participants is depicted in Table 1. All details of the consent protocol by the participants are mentioned in Table 2. About 84.6% of patients knew the exact indication. About 79.3% were well explained the procedure. Ninety-six percentage were satisfied with the outcome of the procedure. Eighty-four percentage preferred the same institute for their subsequent delivery. Twelve percentage reported that consent was forcibly taken. Ninety-four percentage were unaware about the intraoperative complications. Only 4.6% were explained about the preferred mode of delivery for the next pregnancy. Ninety-two percentage wanted a vaginal delivery for the subsequent pregnancy.
Obstetric cases invariably present a very tough stand when it comes to divulging their personal information in an IC. Time and again it remains to be seen how detailed is an IC. In many instances, it is not just the IC but also the postoperative counseling that plays a vital role in good maternal care. Latika etal. in 2015 did a similar study like ours at PT. B. D. S. PGIMS, Rohtak, Haryana, India. Most of the participants in our study belonged to 2130 (78.5%) years of age group and 94.6% were married and 73.2% belonged to the rural background. About 25% of them had studied till middle standard, followed by 21.4% who had studied till matric standard. Ninety-three percentage of patients were adequately informed about the name of the procedure, and 98% of patients had adequate knowledge about the nature of the operation. Eighty-five percentage of patients had adequate knowledge of the indication of the procedure. Sixty-eight percentage had denied having been told the risks of surgery, and a majority (73%) of the patients were not given the chance to ask queries regarding their surgery. About 32.14% agreed having been told preferences for future pregnancies while 67.86% disagreed. Ninety-three percentage of patients refused having been adequately debriefed by health-care providers after surgery. About 37.5% agreed to the fact that they were told that they might need surgery in the future during their antenatal visit, while 62.5% refused.
However, many cesarean sections may undergo an emergency procedure and thus a good IC during antenatal visits will have a good impact on the decisions taken by the patient who will be all the more prepared for the overall consequences. However, it is also true that many times patients are only explained about the indication, while the procedure and complications of cesarean section and other facts are not communicated. The definition of an IC is widely accepted as a voluntary decision for medical intervention made by a sufficiently competent person on the basis of adequate information to accept rather than to reject some proposed action that will harm him or her.
Our study shows that there is still much counseling to be given regarding postoperative complications. Most women in our study wanted only vaginal delivery which undoubtedly raises the obvious question as to the need of such consent. Our findings also are similar to a study done by Ajeet et al. and Sharma et al. Other challenges that one can face in obtaining an IC include cultural diversity, illiteracy, and political will.[4–6] However, we have not analyzed the cultural and political background in our study. Despite knowing the importance of an IC, it is an alarming trend that various hospitals are still maintaining a casual approach using an unstructured proforma or forms with scanty information to obtain consent for surgery.
The government plays a pivotal role to streamline these irregularities in various hospitals and private clinics and ensure that awareness is created regarding this. In a study by Ogunbode etal., some patients have reported a feeling of fear in signing the consent form; sometimes preferring to defer such an important action to their husbands. We have not come across such a situation in our study. However, this possibility does exist. Thus, valid consent must disclose the treatment, risks, benefits, complications, and alternative treatments, in a manner that can enable an ordinary person to make a reasonable decision about its acceptance and rejection.
Consent and documentation in emergencies are another challenging aspects for both doctors and patients. In our study too, despite all formalities, the majority of our cases had to undergo an emergency LSCS. According to a study by Ogunbode etal., all emergency LSCS respondents would likely be less informed than elective cases considering the stressful situation involved while obtaining IC. RCOG Clinical Governance advice guidelines recommended explaining the procedure and obtaining consent in between contractions. We have not tried this option although it can be a useful strategy to help keep the patient focused on the anesthetic options, risks, and procedures. Language was not a barrier for us in our study, however, in a review by Kadam they raised concerns, especially in developing countries, where the core issue is the use of a variety of local languages. We have tried to stick to basic information and make the consent content as short and focused as possible. This was a key element as explained by Bazzano etal. that helped better comprehension from the participants. However, it is beyond doubt that in most cases, it is almost next to impossible for the patients to assimilate and comprehend the information given to them at that time considering the tense situation ahead for them. This was also a point noted in a review by Pietrzykowski and Smilowska. An additional limitation of our study was the small sample size. If the study participants could have been doubled, it would have given us a better perspective regarding patients’ views on IC.
An adequate structured IC brings about awareness about the risks and complications of a cesarean section. Hence, an elaborate counseling session during antenatal visits will help better decision-making. The scope of this exercise can be enhanced by explaining the possible intraoperative and postoperative complications, and by taking the consent in between contractions in emergency situations or advice the husband on the importance of the same. These areas of lacunae if corrected will lead to a better patient–doctor relationship and bring down medicolegal litigations.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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