The global market for intrapartum monitoring devices was worth over USD 1,298.5 million in 2018, and is predicted to reach USD 2,105.7 million by the end of 2025, with a CAGR of 7.2 percent between 2019 and 2025.
Continuous monitoring during labour is accomplished through the use of intrapartum monitoring equipment. These are used to ascertain the patient’s health status and to rule out preventable complications associated with pregnancy and childbirth, such as infection, excessive bleeding, and hypertension. Along with innovations in gynaecological equipment, advancements in intrapartum monitoring devices are critical in mother care. Concerns about enhanced maternity care, an increase in the incidence of preterm deliveries, and global development of healthcare infrastructure all contribute to the growth of the intrapartum monitoring industry.
Additionally, factors such as affordability of intrapartum care facilities and accessibility of access are expected to contribute to improved maternity care. Costly technologies are classified according to their cost, technical feasibility, safety, local use, and efficacy.
The market is segmented by end user into hospitals, maternity centres, and others. In 2018, hospitals accounted for the lion’s share of the market, owing to the availability of enhanced intrapartum devices in this category. The regional segmentation includes present and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa, as well as sub-segments for significant countries.
North America dominated the market in 2018 as a result of increased obesity rates, preterm birth rates, and infant mortality rates in this area. According to CDC (Centers for Disease Control and Prevention) statistics, one in every ten infants born in the United States in 2017 was premature.
Intrapartum monitoring devices are used to monitor women continuously throughout labour. These are used to ascertain the patient’s health state and to rule out preventable pregnancy-related complications such as severe bleeding, infection, and high blood pressure. Advances in intrapartum monitoring technologies are critical for maternal health. Increased preterm births, growing concerns about improved maternity care, and worldwide healthcare infrastructure development are all factors driving the market for intrapartum monitoring devices. Additionally, variables such as price and accessibility of access contribute to improved maternal care.
The market’s growth has been accelerated by technological advancements in the realm of intrapartum monitoring devices. According to WHO statistics, 99.0 percent of maternal deaths occur in settings with limited access to healthcare. As a result, focus is placed on the development of more advanced and cost-effective intrapartum care devices. Additionally, industry participants are delivering higher-quality products to meet growing demand. However, the complications involved with these devices and the stringent regulatory environment are impeding their global market expansion.
The regional segmentation includes present and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa, as well as sub-segments for significant countries. North America and Europe accounted for the lion’s share of the market, owing to the region’s rising obesity rates, infant mortality rates, and preterm birth rates. According to CDC (Centers for Disease Control and Prevention) statistics, one in every ten infants born in the United States in 2017 was premature. Additionally, the growing life expectancy and female population in the European region provide opportunities for market expansion.
According to WHO statistics 99.0 % of maternal deaths occur in situations with little resources for healthcare. Thus, the development of cost-effective and better intrapartum care technology is prioritised. Additionally, advancements in the realm of intrapartum monitoring technologies are propelling the industry forward. Industry leaders are committed to providing superior-quality gadgets in order to meet growing demand. However, the rigorous regulatory environment and complications connected with these devices are impeding their global market expansion.
Intrapartum Fetal Monitoring Devices
One of the most difficult tasks that clinicians confront on a daily basis is delivering a vibrant and neurologically intact infant to each patient. Any result that falls short of this objective instantly compels the physician, the patient, and frequently plaintiff counsel to analyse the intrapartum foetal monitoring process’s techniques and outcomes. Typically, this examination is exhaustive in nature in order to unearth any signs of foetal compromise that may have gone unnoticed or was not addressed effectively.
This chapter discusses the current methods for assessing foetal health during the transition from intrauterine to extrauterine life. The advantages and disadvantages of the various monitoring methods are discussed, as well as their inherent limits. The chapter’s objective is to give a fair and reasonable approach to the difficulty of intrapartum foetal assessment to the practitioner. The importance of continuous intrapartum electronic foetal monitoring (EFM) is highlighted, but the utility and efficacy of supplementary methods like as foetal scalp pH sampling and evoked foetal responses are also discussed.
MEDICATIONS AFFECTING FETAL HEART RATE PATTERNS
It is critical to remember that drugs administered intrapartum to the mother can potentially be transferred over the placenta to the foetus, affecting intrapartum monitoring. The table below highlights several often observed cases.
Table 1: The effect of several drugs on the foetal heart rate
|Butorphanol (Stadol)||Transient sinusoidal pattern|
|Cocaine||No characteristic changes|
|Corticosteroids (such as betamethasone or dexamethasone)||Decrease in variability with betamethasone (not seen with dexamethasone)|
|Meperidine (Demerol)||No characteristic changes|
|Morphine||Decreased frequency of accelerations|
|Nalbuphane (Nubain)||Decreased frequency of accelerations, decreased variability|
|Terbutaline||Abolishment or decrease in frequency of late decelerations|
|Zidovudine (AZT)||No changes|
Risks in intrapartum
EFM performed intrapartum is not without danger. Although serious complications are rare, they might arise in either the mother or the foetus. The single largest danger linked with ongoing EFM use is likely the increased likelihood of caesarean and surgical vaginal birth. The association between continuous intrapartum EFM usage and an increased frequency of diagnosing unsatisfactory foetal condition is widely documented. Similarly, the majority of studies have reported increased rates of caesarean or surgical vaginal delivery when continuous EFM was employed, owing to the increased frequency with which unsatisfactory foetal condition was detected.
These findings are unsurprising, as the goal of intrapartum FHR monitoring is to identify signs that may predict adverse events in order to facilitate intervention, and clinicians have demonstrated an increasing willingness to intervene via caesarean section in order to minimise the risk of foetal hypoxemic morbidity and mortality. It is impossible to identify with certainty the extent to which medicolegal factors contribute to greater detection of possible foetal deterioration and the associated increase in caesarean delivery rates. However, experienced clinicians acknowledge that litigation for failure to conduct a caesarean delivery in a timely manner is far more common than litigation for doing an unnecessary caesarean delivery.
Perforation of the uterus can occur during the insertion of the intrauterine pressure catheter. This risk can be reduced by using soft catheters, avoiding excessive force during placement, and employing an insertion technique that minimises the potential of the catheter guide extending beyond the clinician’s outstretched fingers. If there is a suspicion of perforation due to the absence of pressure changes with palpable uterine contractions or a positive change with a maternal Valsalva manoeuvre, the catheter should be withdrawn promptly. After catheter removal, close maternal–fetal surveillance is recommended, but surgical exploration (e.g., due to sudden intra-abdominal bleeding) is uncommon.
Significant foetal bleeding following the placement of an internal scalp electrode or the assessment of the foetal scalp pH is uncommon. When haemorrhage occurs following scalp electrode implantation, it is reasonable to suspect placental perforation or abruptio placentae. Apt or Kleihauer–Betke tests may be used to determine the source of such bleeding. If bleeding continues after three contractions following scalp penetration for pH testing, despite application of pressure with long, cotton-tipped swabs, some writers recommend inserting a small clip over the puncture site to achieve hemostasis. If vaginal birth is not imminent, persistent bleeding that occurs with any monitoring adjustment and is accompanied by unsettling FHR variations may be an indicator for abdominal delivery.
Intrapartum monitoring with an intrauterine pressure catheter, a scalp electrode, or scalp pH determination increases the risk of infection problems in the mother or foetus. Neither postpartum endometritis in the mother nor newborn scalp infection are common complications. Often, sterile neonatal scalp abscesses resolve fast with cautious surgical drainage and local treatment. However, more significant scalp infections have been recorded as a result of FSE placement sites. There is scant evidence that the rate of postpartum endometritis is significantly higher in patients monitored invasively than in people followed externally during vaginal birth. However, invasive foetal monitoring should be avoided in patients who test positive for HIV or hepatitis.
Intrapartum EFM may encounter resistance from some individuals and health-care providers. As Jessica Mitford observed in a scathing best-seller attacking contemporary obstetric techniques, “one of the most sincere objections (of mothers) to their hospital experience… was their coerced endurance of this obstetrician’s weapon of the trade.” Anxiety and aversion to intrapartum EFM may be a result of a lack of or inaccurate information.
EFM is not incompatible with natural delivery, and prepared birthing classes should provide accurate information about the procedures and rationale for foetal monitoring. Monitoring is a screening test meant to identify prospective difficulties, not a test done exclusively when the foetus appears to be in distress. When appropriately read and communicated, continuous EFM data can reassure the patient, her family, and the entire health care team. Patient education, which may include educational materials and consultation with nursing and physician staff, will assist in resolving several patient concerns and reducing patient anxiety. In an ideal world, this educational process would begin during prenatal care.