INTERVIEW - Maternal health today; medical achievements and challenges - Dr. Juan Manuel Enciso

Interview to Dr. Juan Manuel Enciso Meraz. Is a gynecologist and obstetrician specialized in fetal-maternal and surgical medicine. He holds a Fetal Medicine Foundation Certificate and a Certificate from the Mexican Board of Gynecology and Obstetrics; he is a member of the International Society of Ultrasound in Obstetrics and Gynecology. A former head of the Fetal Medicine Unit from the CMNO Hospital of Gynecology and Obstetrics.

One of the main objectives of clinical research is the creation of useful generalizable knowledge. Its purpose is to resolve the questions about diseases that afflict humanity and aims to solve the lack of certainties responsibly and rigorously, with quality data and respect for the individuals involved in the study. Few of them, however, are designed to address relevant questions of interest for pregnant women.1

Dr. Juan Manuel Enciso, according to your extensive experience in maternal-fetal medicine and considering further research that could be performed in the field, WHAT ARE THE BENEFITS THAT PREGNANT WOMEN COULD OBTAIN BY ENTERING A CLINICAL TRIAL?

The patient benefits from enrolling as she will receive better medical care including tests and studies, in greater quantity, quality, and in less time than the usual care. Another important point is that these interventions usually do not generate costs, as they are absorbed by research centers and foundations. In addition, in the medium and long term, there is the potential of positive results and that the treatment and benefits will be received before the population, and without any fees. Participating in trials also implies a benefit for the society, since it is possible for the patient to help other patients to obtain better management and thus, improving the population quality of life. Likewise, by participating, support groups are formed, which provide constant information about the pathology, allowing the shaping of closer doctorpatient and patient-patient bonds, and granting for greater emotional support.

A relevant study that I can cite is the MOMS (Management of Myelomeningocele Study), carried out in 2011, in which pregnant patients with an infant with open spinal defect were invited to participate in order to perform an intrauterine surgery or an intervention once the infant was born. The study had such good outcome with fetal surgery that it had to be stopped because the benefit was so great that it was ethically not possible to continue operating on the defect until birth, establishing a change in the paradigm of treatment of fetuses with myelomeningocele, as the gold standard in the management of this pathology.

In the same vein, WHICH ARE THE ETHICAL ISSUES INVOLVED IN CLINICAL TRIALS IN PREGNANT WOMEN, WHAT SHOULD PARTICIPANTS BE AWARE OF BEFORE ENTERING ONE?

Invariably, before initiating a research protocol, an ethics committee has to grant its approval to start the study. This means that a group of people from different specialties, and even from different professions are aware of the benefits, risks, and the whole theoretical context presented by the researchers, such as results in animal models, complications, adverse effects, etc. Through this information, the committee can pronounce a judgment. In other words, it is impossible to initiate a clinical trial without the approval of the ethics committee.

Whenever a patient participates in a protocol, she is given a document that informs her of the potential benefits, as well as the adverse effects, risks, forms of management, interventions, and even whether it will be necessary for the patient to remain close to the care unit. It is important to clarify that the patient can refuse to participate in the study at any time and that she will always have a physician responsible for her care, as well as the telephone number of the physician.

After having provided care to countless pregnant patients, WHAT ARE THE DRUGS OR TREATMENTS YOU RECOMMEND FOR THE PROPER DEVELOPMENT OF INFANTS DURING PREGNANCY?

The World Health Organization recommends the use of 0.4 mg of folic acid from three months before conception, as it prevents neural tube defects, as well as adding 30 to 60 mg of elemental iron once pregnancy is established to prevent low birth weight, prematurity, maternal anemia, and even sepsis. It should be highlighted that alcohol consumption should be discontinued as there is no "safe" amount to consume since it can cause neurotoxicity and thus, reduced intellectual and motor performance. Patients who are chronically hypertensive or with epilepsy should consult with their physician about changing medications that are considered safe during pregnancy.

As is well known, all pregnancies involve some health risks, however, ARE THERE DISEASES DIRECTLY ASSOCIATED WITH POORLY CONDUCTED PREGNANCY?

Prenatal consultation is important, which provides time to correct previous maternal disorders, or even to be able to change to safer drugs during gestation. Obstetric care is individualized in each case since there are national and international standards that dictate the weeks at which patients should be screened to have a better maternal and perinatal outcome. It is important that the structural review be performed by a maternal-fetal physician These reviews are carried out from week 11 to 14, after week 18 to 24, and finally, in the third quarter of pregnancy.

Level II or structural screening allows the diagnosis of malformations, deformities, disruptions, sequences, associations, as well as establishing the risk for chromosomal alterations such as Down syndrome, prematurity, and preeclampsia. In case of chromosomal alterations, invasive or non-invasive procedures will be established jointly with the patient in order to be certain of the diagnosis. In the event of finding a structural defect, a management plan, prognosis and, in some cases, fetal surgery will be established. So, comprehensive care can be offered, minimizing maternal and/or fetal risks.

Keeping in mind the thalidomide tragedy, which occurred in the late 1950s, when more than 10,000 infants born to mothers who consumed this drug during pregnancy were born with severe irreversible malformations, WHAT MEASURES HAVE BEEN IMPLEMENTED IN THE WORLD OF CLINICAL RESEARCH TO AVOID SIMILAR MISFORTUNES?

Thalidomide was a drug used for nausea that caused a large number of malformations (phocomelia). Following this unfortunate event, reforms were made to clinical testing of drugs, which impose strict limits on the tests and distribution of drugs, establishing that efficacy must be determined before marketing. There are different organizations such as the FDA (United States Food and Drug Administration) and COFEPRIS (Mexican Federal Commission for the

Protection against Sanitary Risks) which, together with those responsible for public health, guarantee the safety and efficacy of drugs, biological products, medical devices, food supply, cosmetics, dietary supplements, and radiation-emitting products.

FINALLY, WHAT IS THE GREATEST CHALLENGE CURRENTLY FACED BY PHYSICIANS AND HEALTH CARE PROVIDERS IN THE FIELD OF MATERNITY AND PUBLIC HEALTH?

COVID-19 is undoubtedly the issue, as it is currently the leading cause of maternal death in Mexico, surpassing preeclampsia, and obstetric hemorrhage, which have been the main causes of death before the pandemic. This represents a great effort on the part of institutions to be able to provide adequate and timely care to avoid complications. However, due to the nature of the pandemic, it will be necessary to consider vaccinating pregnant women as soon as information on the safety of vaccination is available since this group is undoubtedly at risk.

Given the prevalence of obesity and its association with hypertensive disorders of pregnancy and gestational diabetes, it is necessary to take the relevant measures to reduce the potential of presenting these pathologies that confer a high risk of unfavorable outcomes. These include changing the concept of the traditional diet based on high carbohydrate content, encouraging routine exercise, and carrying out universal prenatal monitoring in order to identify mothers at risk of preeclampsia and initiate timely treatment and follow-up, as well as to detect fetuses at risk of chromosomopathies, prematurity, altered growth, malformations, and, in the latter, to be able to carry out, in some instances, intrauterine treatment, or to bring both the mother and fetus in optimal conditions for a safe birth.

Finally, WHAT HAVE BEEN SOME OF THE MOST RELEVANT ADVANCES IN THE HISTORY OF MODERN MEDICINE IN TERMS OF CLINICAL RESEARCH AND MATERNAL HEALTH?

Several events have changed the management of fetal medicine; previously, mothers with Rh-negative hemotype, who already had antibodies against the positive fetal blood type, had amniotic fluid extracted through an abdominal puncture to assess the degree of anemia. Nowadays, the diagnosis is made through a non-invasive test, performed by ultrasound in a modality described as doppler of the middle cerebral artery of the fetus, allowing to accurately determine if the fetus is anemic.

Another great advance is fetal surgery, which allows improving the prognosis of several malformations, as well as the quality of life, e.g., the separation of placentas by laser in fetal-fetal transfusion, a pathology characterized by sharing placental circulation in a twin pregnancy, which significantly improves the potential of life of both fetuses with no neurological sequelae.

1. Salmún, D. (2019). Investigación clínica en el embarazo: un llamado a participar en el cambio de paradigma – Parte l. Revista del Hospital Materno Infantil Ramón Sardá. 2(4). Retrieved from: http://www.sarda.org.ar/images/2019/2019-2_1_Editorial.pdf 2. As of February 15, 2021.

Dr. Juan Manuel Enciso Meraz

The interview was generated by the publishing house of the Clinical Research Insider.