Dr. Saswati Tripathy is currently working as Professor of Obstetrics and Gynaecology at SRM Medical College Hospital and Research Centre, Tamil Nadu. She has done her post-graduation from the prestigious SCB Medical College, Cuttack, Odisha. She is a fellow of Indian College of Obstetricians and Gynecologists. Her area of interests are operative obstetric care, high risks pregnancy and infertility.
Informed consent process has become a challenging issue before surgery for any emergency obstetric care during this COVID pandemic. There is an increased risk of morbidity if there is a need of intensive care unit postoperatively and a risk of high mortality if patient has symptoms of COVID-19. Admission to intensive care unit adds on to the financial burden to the patient. Also, there is an increased risk of perinatal anxiety and depression during the COVID pandemic. When an asymptomatic carrier develops symptoms of COVID after delivery or caesarean section, the morbidity increases. So we have designed an informed consent form for patients undergoing emergency obstetric surgeries incorporating some points specific for COVID-19.
Keywords COVID-19 • Pandemic • Informed consent
Pregnancy and delivery pose unique challenges during the coronavirus disease (COVID-19) pandemic due to altered maternal immune system [1]. In India, the institutional deliveries have been increased in last decade and there is a huge burden in hospital settings during this pandemic. Obtaining a valid informed consent in humanitarian emergencies such as COVID-19 is a challenge. There are practical difficulties in identifying a COVID-19 positive patient. According to the recent ICMR (Indian Council of Medical Research) guidelines, if a woman meets the criteria for COVID-19 testing like travel history from an affected area or close contact with a confirmed case of COVID-19, she should be tested. Until RT-PCR (real-time reverse transcription polymerase chain reaction) test results are available, she should be treated as though she has confirmed COVID-19 [2]. So during that time it is a challenge to obtain the consent from the patient covering all aspects of the informed consent process. Informed consent is a continuous process involving three main components—providing relevant information, ensuring competence, ensuring comprehension and voluntariness [3]. In addition, the decisional capacity of the hospitalized patient would be very low during this pandemic. Also, there is an increased risk of the need of intensive care unit (ICU) for ventilator facilities as well as an associated risk of high morbidity and mortality if the patient exhibits symptoms of COVID-19 in the postoperative period.
Therefore, we have devised a new informed consent format for all patients undergoing emergency obstetric surgeries incorporating a few points specific for the COVID-19 disease.
Informed consent for emergency obstetric care, which is a critical component of surgical practice, has become a challenging issue in the time of COVID-19 infection. There are few specific requirements which need to be discussed pre-op during this pandemic with the patient and the relatives, in order to avoid any unnecessary medico legal issues. Reports have shown that over a recent 5-year period, 65% of medico legal cases involving informed consent were surgical and only 21% of these cases were decided in favor of the surgeon [4]. It is mandatory that prior to obtaining consent for the proposed surgery, the obstetrician must provide the patient with detailed information about the nature of the surgery, the expected risk and benefits, alternate treatments and the consequence of not having the surgery [5].
In India, the need for ICU and ventilator support in the post-op period, if required, must be discussed with the patient's relative as it involves an increased financial burden. There are also concerns about the lack of pre-op COVID testing due to paucity of commercial testing kits. But preop COVID testing should be done for elective surgeries if the facilities are available. A normal patient may develop or contract coronavirus infection in the peri- or postoperative period which should be again documented in the consent form. All the potential risks, short term or long term should be informed to the patient.
Hence, a detailed modified consent form was designed exclusively for the patients who require emergency obstetric surgeries during this pandemic.
Conflict of interest The author declares thatthere is no conflict of interest.
Ethical Statement This article does not contain any studies with animals performed by any of the authors.
