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Does intrapartum CTG monitoring save lives?

Dr Kirsten Small is a project lead with the Transforming Maternity Care Collaborative. Yesterday she delivered the closing keynote address at the GOLD Obstetric Conference, speaking about why it is so difficult to align clinical practice with the research evidence. Kirsten hosts the Birth Small Talk blog and her post today reviews the research evidence she summarised in her address. She has kindly shared it here as well. 

If you are interested in pursuing research relating to the use of fetal heart rate monitoring in labour please connect with us via our contact form

 

Today’s post examines the research evidence about CTG monitoring with regards to stillbirth and neonatal death. This is a deep dive for my fellow data geeks who like to read the fine print, not the executive summary. The short version is – no. Using a CTG to monitor a woman in labour doesn’t prevent the death of her baby. If you are keen to know the details, read on!

Intrapartum CTG monitoring in low risk populations

This is the least controversial area of evidence, and the one most maternity clinicians are familiar with. Of the eleven randomised controlled trials that have compared CTG monitoring with intermittent auscultation (IA) during labour, three were done in low risk populations, five in high risk populations and the remaining three in mixed risk populations or where risk was not specified (Alfirevic et al., 2017).

The three low risk trials were Kelso et al., 1978, Leveno et al., 1986 and Wood et al., 1981. A total of 16,049 births were included in this analysis, which showed no statistically significant difference in the perinatal mortality rate (RR 0.87, 95% CI 0.29 – 2.58).

It has been almost 40 years since the last of these trials was performed. It could be argued that CTG technology has improved, or that we are better at CTG interpretation now. Heelan-Fancher et al. (2019) examined a large population data set from two states in the United States, specifically looking at birth outcomes for low risk women. This was not a randomised controlled trial – rather it was a non-experimental analysis of what happens in practice when women are monitored by CTG or by IA, with a very large sample size (1.5 million births). They didn’t report on intrapartum stillbirth. They found no significant difference in the neonatal mortality rate when CTG monitoring was used.

On the basis of available evidence, there is nothing that suggests that use of CTG monitoring rather than IA reduces the perinatal mortality rate in women considered to be at low risk. That’s not all that controversial. Most people in maternity care know this particular bit of information.

Intrapartum CTG monitoring in mixed, unknown, and high-risk populations

There is a widespread assumption that the absence of mortality benefit derived from CTG monitoring in labour ONLY applies to women considered to be low risk. We wouldn’t be using CTGs so widely if they didn’t save lives, right? But what does the evidence actually say regarding the use of intrapartum CTG monitoring in women who are not at low risk?

The randomised controlled trial evidence regarding high risk populations consists of five studies published over 6 papers, over a thirty-year period, starting in 1976 and continuing to 2006 (Haverkamp et al., 1979; Haverkamp et al., 1976; Luthy et al., 1987; Madaan and Trivedi, 2006; Renou et al., 1976; Shy et al., 1987). In addition, there are four studies published over five papers which were conducted in populations with both women considered to be at lower and higher risk or where the risk profile of the population was not described (Grant et al., 1989; Kelso et al., 1978; MacDonald et al., 1985; Neldam et al., 1986; Vintzileos et al., 1993). With my co-authors Associate Professor Mary Sidebotham, Professor Jenny Gamble, and Professor Jennifer Fenwick, we have synthesised the findings from these populations (Small et al., 2020).

In the high-risk population (n = 1,975), perinatal mortality was not significantly different when CTG was compared with IA (RR 1.17, 95% CI 0.62 – 2.22). There was also no statistically significant difference in mortality in the mixed-risk population (n = 15,994, RR 0.67, 95% CI 0.36 – 1.23). The mortality rate was higher in the mixed risk population than it was for the low risk population, and higher again for the high-risk population, indicating that researchers have correctly identified populations of women with higher risk.

Note that the number of women in the high-risk population is small. It has been argued that with a larger sample size a difference would be detected but that it would be unethical to recruit women considered to be a high-risk to further RCTs because the non-experimental evidence supporting the use of intrapartum CTG monitoring is so compelling. We set out to examine this assertion and examined the nonexperimental evidence (Small et al., 2020).

Non-experimental research

Our searches located 27 papers published between 1972 and 2018 which provided evidence about the use of intrapartum CTG monitoring in high-risk populations. We then used a tool (ROBINS-I) to assess the degree to which the findings of the research might be affected by bias – that is that the findings were due to something other than CTG use. 22 papers were at critical risk of bias and another was a serious risk. Most of these papers compared a time period prior to the introduction of CTG monitoring with a period after it was introduced, without controlling for any of the other changes to practice which might improve outcomes over time. Given the high risk of bias, the findings from these papers should not be relied on to guide practice as a consequence. The remaining five studies were assessed to be at moderate risk of bias. According to the ROBINS-I tool, studies at moderate risk of bias can be relied upon to inform clinical practice.

Starting with the studies at critical or serious risk of bias, only five of these studies showed a statistically significant reduction in perinatal mortality out of fourteen where this could be calculated. In the studies at moderate risk of bias (which ranged in size from 235 to 1.2 million women), no significant differences in perinatal mortality rates were reported. The argument that the non-experimental evidence presents a compelling argument for intrapartum CTG monitoring can’t be sustained on the basis of the available evidence.

Where to next?

Where does that leave us as clinicians and what recommendations can we make on the basis of these findings? We have an ethical obligation to include information regarding the lack of effectiveness of CTG monitoring in our discussions about intrapartum fetal monitoring with birthing women, regardless of their risk profile (Sartwelle et al., 2020) and to support their informed decision making. However, doing currently places clinicians at odds with professional guidelines. Professional guidelines are meant to be evidence informed, yet this is clearly not the case for intrapartum fetal monitoring. In order to support clinicians to provide evidence-informed care, there needs to be stronger recognition in professional guidelines that the evidence in favour of intrapartum CTG monitoring is far from compelling and that using IA instead is not proof of unprofessional practice.

The full reference list is available on the post on Birth Small Talk. 

 

Mental health screening during pregnancy and after birth is even more important right now

Professor Debra Creedy 

Up to 15% of pregnant women in Australia, and 21% of mothers of infants up to four months of age will experience depression. The presence of anxiety, which frequently co-exists with depression, is estimated to also be as high as 20%. Depression during pregnancy and/or the postpartum period can have profound effects on not only a woman’s long-term health and well-being but can also adversely affect her relationship with the baby and her partner.

We currently don’t know the impact of life changes and restrictions related to COVID 19 on the emotional wellbeing of childbearing women. A systematic review of clinical outcomes of 3559 hospitalised patients (in 72 different studies) was published in the Lancet (18th May, 2020). Rogers and colleagues concluded that if the pattern for COVID 19 follows that of similar pandemics (such as SARS in 2002) many admitted patients will experience confusion, acute depression, anxiety, and sleep difficulties. After the illness, 32.2% patients from these combined studies reported post-traumatic stress, and around 15% reported symptoms of depression and anxiety. This data highlights the importance of assessing the emotional wellbeing of not only people with COVID19 but for members of the community who may be at risk, such as pregnant women. However, the approach to screening for depression and/or anxiety during pregnancy and the postpartum varies a great deal.

In an effort to promote common approaches to assessment and measurement of patient outcomes and experiences, core outcome sets are being developed for a range of conditions and used in practice. A core outcome set is an agreed set of outcomes that should be measured and reported. In 2016 the International Consortium for Health Outcomes Measurement (ICHOM) published a core outcome set to evaluate value in maternity care. Acknowledging mental health as an outcome important to women, the ICHOM Working Party included the Patient Health Questionnaire (PHQ-2) and the Edinburgh Postnatal Depression Scale (EPDS) to measure symptoms of perinatal depression.

Currently in Australia, United States, and Canada clinical guidelines recommend that all women should be screened during pregnancy and at least once in the postpartum using the Edinburgh Depression Scale (EPDS). Whereas in the United Kingdom, health professionals undertake selective screening using two brief questions similar to the PHQ-2 – During the past 2 weeks, have you been bothered by (1) ‘feeling down, depressed or hopeless’; and (2) ‘little interest or pleasure in doing things’. If a woman says ‘yes’ (been bothered for several days =1; more than half the days = 2; or nearly every day =3) to one or both questions, then she is asked to complete the EPDS (10 questions). Subsequently, ICHOM recommended using the 2-item PHQ-2 to screen all women, followed by the EPDS if a woman obtains a score of 3 or more (known as a ‘positive’ screen). But the extent to which the PHQ-2 could correctly identify and not miss childbearing women at risk of depressive symptoms had not been tested and further research was needed.

We aimed to compare the screening accuracy of the PHQ-2 to identify women at risk of probable depression during pregnancy and the postpartum. We recruited 309 pregnant women who completed the PHQ-2 and EPDS (at their booking-in appointment around 36-weeks) and postpartum (at 6 and 26-weeks) 4.

The accuracy of the PHQ-2 was tested using two methods (1) scored cut-points >2 and >3, and (2) dichotomous yes/no (positive response to either question) against EPDS cut-points for probable major and probable minor depression. We were interested in the ‘sensitivity’ of the tool – that is, the ability of the PHQ-2 to correctly identify women with depression (known as the true positive rate), and ‘specificity’ – the ability of the PHQ-2 to correctly identify those women who do not have depression (true negative rate).

Our analysis revealed that the dichotomous yes/no (positive response to either question) had the highest sensitivity (81 – 100%). While specificity was low (60 – 74%) we felt that this shortcoming was outweighed by the ability of the PHQ-2 to correctly identify those women at risk for depression.

COVID19 will challenge the mental health of many people in our community, so we shouldn’t stop mental health screening. Our research highlights the importance of supporting women’s mental health through pregnancy and the first year post birth, and why having screening tools that are simple, easy to use tools, and ‘fit for purpose’ in the face of changes to care provision are important. Women receiving continuity of care from a known midwife throughout pregnancy and up to 6 weeks postpartum are more likely to be screened for depression and are more likely to confide in their midwife about concerns and worries.