Table 1 Summary of evidence review findings aligned with GRADE EtD criteria
EtD criteria/sub-criteria | Main findings | Qualitative evidence sources |
|---|---|---|
Values | ||
Sub-criteria Patients’/beneficiaries’ values in relation to health outcomes Framing questions To what extent do patients/beneficiaries value different health outcomes? | Labour induction in general Women placed great value on knowing about the potential benefits and harms of labour induction. They were concerned about the timing of delivery and its impact on the well-being of their baby (Will the baby be harmed by being born too early? Will the baby be harmed by being born too late?); the duration of the induction process until onset of labour and birth; the severity of pain; and the likelihood of caesarean delivery. Outpatient labour induction Women who underwent outpatient labour induction had additional safety concerns about going home, particularly in relation to being able to recognize if something was wrong. Some women were also concerned that labour might start suddenly at home. Women who were induced in an inpatient setting reported how painful induction was, whereas women who had outpatient induction did not mention pain. | |
Resources | ||
Sub-criteria Financial impact Framing questions What is the cost of the intervention? What is the overall budget impact of implementing the intervention? Do cost and budget impacts vary in the short- versus longer-term, and are they sustainable? | Economic evidence was very limited for the three induction of labour topics, derived from five trial-based primary studies conducted in high-income settings only. Economic analyses were eligible for all three induction of labour topics if the majority of the population was either at or beyond term and otherwise low-risk, and additionally for induction setting if the study compared the same induction method in both arms. Induction of labour at or beyond term Goeree et al. reported a mean cost saving per woman with labour induction of CAD 193 (95% CI 133 to 252) compared with expectant management [31], with effectiveness and resource utilization data from Hannah 1992 [45]. Grobman et al. reported that women who underwent labour induction used fewer resources in the antepartum period. During the intrapartum period, overall resource use was similar between the groups, however with different types of resources used. Postpartum resource use was largely similar between the two groups [32]. Resource utilization data were from a randomized controlled trial (RCT) conducted in 41 United States hospitals [46]. Outpatient induction of labour Adelson et al. undertook a cost analysis of outpatient vs inpatient labour induction [33], with effectiveness data from an RCT conducted in two Australian hospitals using vaginal PGE2 gel [47]. It is uncertain whether outpatient labour induction results in in-hospital cost savings or overall cost savings once the cost of the outpatient priming clinic was taken into account. Mechanical methods of induction of labour Ten Eikelder et al. undertook a cost-effectiveness analysis from a hospital perspective in the period from admission to antenatal care ward to discharge [34], with effectiveness data from an RCT in 29 hospitals in the Netherlands comparing oral misoprostol with Foley catheter [48]. It is unclear whether the Foley catheter is cost-saving for labour induction compared with oral misoprostol. The authors noted that at a willingness-to-pay threshold of at least €30,000 (2013 euro) per woman, oral misoprostol may be cost-effective for preventing caesarean section [34]. Van Baaren et al. undertook a cost-effectiveness analysis from a hospital perspective [35] using effectiveness data from an RCT in 12 hospitals in the Netherlands comparing Foley catheter with vaginal prostaglandin E2 gel [49]. It is unclear whether the Foley catheter is cost-saving for labour induction compared with vaginal PGE2 gel. | |
Sub-criteria Ratio of costs and benefits Framing questions What is the value-for-money of the intervention, based on an appropriate choice of method, e.g. cost-effectiveness, cost–benefit or cost-utility? | ||
Equity | ||
Sub-criteria Impact on health equality and/or health equity Framing questions Is the intervention likely to reduce or increase existing health inequalities and/or health inequities? Does the intervention prioritize and/or aid those furthest behind? How do such impacts on health inequalities and /or health inequities vary over time, e.g. are initial increases likely to balance out over time, as interventions are scaled up? | We did not identify any direct evidence specific to induction of labour that addressed health equity. However, a 2015 WHO report on inequality in reproductive, maternal, newborn and child health states that “the poorest, the least educated and those residing in rural areas have lower health intervention coverage and worse health outcomes than the more advantaged” [50, p. xii]. The report also found that preventing and reducing morbidity and mortality in childbirth can play a key role in reducing overall health inequities [50]. Safe, effective and equitable implementation of labour induction for improved maternal and neonatal health outcomes could therefore potentially contribute to reducing inequities in maternal and perinatal health. Women living in low- to middle-income settings and/or remote or rural areas are less likely to have access to antenatal care to enable accurate gestational age estimation and risk assessment, or well-resourced facilities for monitoring and assessing maternal and foetal well-being during labour induction and/or performing caesarean sections if required [50,51,52]. This may reduce women’s ability to safely access labour induction, leading to poorer health outcomes, and reinforcing existing health inequities. | |
Sub-criteria Distribution of benefits and harms of the intervention Framing questions How are the benefits and harms of the intervention distributed across the population? Who carries the burden (e.g. all), who benefits (e.g. a very small subgroup)? | The recently updated Cochrane reviews do not provide evidence to enable assessment of whether the balance of benefits and harms in relation to the three topics varies in different population subgroups [1, 17, 18]. | |
Sub-criteria Accessibility of intervention Framing questions How accessible—in terms of physical as well as informational access—is the intervention across different population groups? | The question of physical access was considered under the sub-criteria “Impact on health equality and/or health equity”. In terms of informational access, women from communities, populations and settings who are systematically denied equitable access to social, political and economic resources may experience greater barriers to participation in healthcare decision-making than indicated in the QES findings (see below under Acceptability) [53,54,55]. | |
Acceptability and human rights | ||
Sub-criteria Sociocultural acceptability of intervention to patients/beneficiaries and those implementing the intervention Framing questions Is the intervention socioculturally acceptable to patients/beneficiaries as well as to those implementing it? To which extent do patients/beneficiaries value different non-health outcomes? | Labour induction in general (women) Women have varying, and sometimes contradictory, views on the acceptability of labour induction. Acceptability varies according to women’s trust in their healthcare provider, their perception of birth as a natural process, their need for certainty, and the duration of waiting. Labour induction is widely acceptable to women when there is a recognized need to avert harm to the baby. Some women prefer interventions they can employ themselves to medical induction of labour. Outpatient induction of labour (women) Women value aspects of outpatient induction such as access to continuous social support; the freedom to move around and continue with their daily activities; being comfortable and being able to rest; having distractions waiting from waiting and pain. However, women who underwent outpatient induction also had additional safety concerns about going home. Coates et al. concluded that “outpatient IoL [induction of labour] is not preferable for all women, and individuals will have preferences about what constitutes a comfortable and safe environment for labour” [36, p. 26]. Labour induction in general (implementers) There is limited evidence available on the acceptability of labour induction to clinicians. A single study of obstetrician and midwife opinions on labour induction conducted in a high-income setting found that obstetricians felt there was a lack of clear evidence on the risks and benefits of labour induction to guide their decision-making. They were particularly concerned about neonatal safety and the potential for medical litigation, and were uncertain about the optimal timing for induction and the risks of caesarean birth following induction [42]. | |
Sub-criteria Sociocultural acceptability of intervention to the public and other relevant stakeholder groups Framing questions Is the intervention sensitive to sex, age, ethnicity, culture or language, sexual orientation or gender identity, disability status, education, socioeconomic status, place of residence or any other relevant characteristics? | We did not find any direct evidence to answer this question. | |
Sub-criteria Accordance with universal human rights standards and principles Framing questions Is the intervention in accordance with universal human rights standards and principles? | Human rights include claims for health goods and services, and the right to information that enables women to be active agents when making decisions that affect their health [56]. Effective communication, respect and preservation of dignity, and emotional support are also vital to protection of human rights in healthcare [57]. Women generally wanted more timely and complete information about the risks and benefits, and process, of labour induction to enable them to make a competent, informed and voluntary decision about the intervention. They wanted to receive this information at a time and in a context that allowed them to process the information before a decision was required. There was a general perception that the timing and decision to induce labour was determined by the healthcare professional, or facility or system constraints. Women valued setting and systems that provided them with privacy, dignity and control, and where they could communicate their needs and have them responded to. Women were disturbed by the lack of privacy and freedom to move in the hospital setting. Women could also feel isolated and alone, and unable to access continuous support from induction through to birth. Some women experienced undergoing labour induction in hospital as a place of safety and security, knowing they had immediate access to healthcare providers and technology. | |
Feasibility | ||
Sub-criteria Need for, usage of and impact on infrastructure Framing questions How does the intervention interact with the need for and usage of the existing health system infrastructure (e.g. types of health facilities, health information system, medical products and technologies) at national and subnational levels? Is it likely to impact on these and their performance in positive or negative ways? | Labour induction is widely implemented in high-, middle- and low-income settings [41, 50,51,52], however performing induction of labour safely requires availability of appropriate drugs or mechanical devices, monitoring equipment and access to facilities for safe caesarean section. Inconsistent supply, or lack of, drugs and medical equipment and availability of appropriate facilities may be an issue in some settings. | |
Sub-criteria Need for, usage of and impact on health workforce and human resources Framing questions How does the intervention interact with the need for and usage of the existing health workforce? Is it likely to impact on these in positive or negative ways, for example by affecting the number or distribution of staff, their skills, responsiveness or productivity? | Labour induction in general In lower- and middle-income country settings, trained healthcare worker shortages may reduce the feasibility of performing antenatal ultrasound scans and other risk assessment [50]. Time constraints can also be a barrier to information provision in antenatal care clinics [36]. Healthcare worker shortages in low- and middle-income country settings may require staff to attend to much higher numbers of women on the labour ward than in other settings. Providing the required level of support, assessment and monitoring in these settings may be challenging and impact on responsiveness [52]. Availability of surgical obstetric and operating theatre staff for women who require caesarean delivery if labour induction is not successful may also impact on feasibility. A higher number of induction deliveries are attended by medical doctors than non-induction deliveries [52]. This may have implications for the distribution and productivity of medical doctors, particularly in under-resourced settings Outpatient induction of labour There may be a greater need for staff who are available to answer questions, monitor and assess women remotely, and/or organize care or transfer for women who experience adverse reactions at home, such as uterine hyperstimulation, for outpatient induction of labour [18]. | |