 This response was put together by Shellie Poulter with the help of Elizabeth Odunlami. We have also included responses and comments from members and other contributors. 1. The reasons for induction being offered – This needs to have CLEAR medical reasons as to why an induction is being offered as birthing people are very often pressured into induction, do not know they have a choice to decline induction or are told their baby is at 50% increased risk of dying if they don’t have an induction. This is not evidence-based information and is coercion and therefore can’t be described as an informed decision that is being made.
“Patient-perceived pressure from clinicians significantly predicts labour induction and caesarean delivery. Efforts to reduce provider–patient miscommunication and minimize potentially unnecessary procedures may be warranted.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4545342/ Whilst it is clear that not all clinicians are statisticians, guidance needs to be given when asking clinicians to provide information on the increase in risk for pregnant people when considering whether or not to induce labour: the increase in risk should be provided in absolute NOT relative terms thereby giving the deciding family a clear indication of what risks they will potentially expose themselves to. The right to refuse induction of labour must be clearly communicated “Women feel unable to request anything other than what medical staff suggested” Lou S, Hvidman L, Uldbjerg N et al (2018). Women‘s experiences of post term induction of labor: A systematic review of qualitative studies. Birth: Issues in Perinatal Care. https://doi.org/10.1111/birt.12412 2. The alternative options need to be clearly laid out and explained in the guidelines so that all evidence-based information and choice are clearly stated. There are always pros and cons of all choices and this information should be balanced, not just stating negatives for one option and not the other. Long term impacts of Induction on Child and mother health and well-being also need to be considered and have not been in this guidance or evidence review The evidence in the latest research by Dahlen et all (2021) clearly indicates that “IOL for non-medical reasons was associated with higher birth interventions, particularly in primiparous women, and more adverse maternal, neonatal and child outcomes for most variables assessed.” https://bmjopen.bmj.com/content/11/6/e047040 3. The information on the NHS website needs to be evidence-based information that is accurate, true and up to date. NHS website “If you're overdue Induction will be offered if you do not go into labour naturally by 42 weeks, as there will be a higher risk of stillbirth or problems for the baby.” This is not clear information and using terms such as ‘higher risk’ is not giving people enough detail to consider all their options. This information needs to be up to date and clear, showing the figures and actual risks and also include the pros and cons of each choice. NHS website “If your waters break more than 24 hours before labour starts, there's an increased risk of infection to you and your baby.” Where is the evidence to support this? If waters break before 37 weeks, expectant management is deemed appropriate. Why is this not the case after 37 weeks? What evidence is there for a 24 hour cut off period? This used to be 96 hours and many trusts had a 48 hour guideline. Some trusts are stating reasons for induction that have not been shown in research studies. E.g. NHS Isle of Wight Induction of Labour document states that “there is an increased risk of a baby developing problems as the placenta becomes less efficient” There is no evidence to support this statement, so the information is not evidence-based that is being given as a reason for induction. Birthing people are therefore, offering their consent based on FALSE information. One approach to limiting the unnecessary use of antimicrobials is to use the “sepsis calculator” developed by Puopolo et al [205] to estimate the probability of early-onset sepsis (EOS) using maternal risk factors in neonates born at 34 weeks of gestation or Later. Utilizing data from more than 600,000 infants at at least 34 weeks’ gestation at birth, the investigators developed a model for EOS risk prediction based on objective maternal factors, then combined that model with findings from examination of the infants. [206] The model uses three categorical variables: group B Streptococcus (GBS) status (positive, negative, uncertain), maternal intrapartum antimicrobial treatment (GBS-specific or broad spectrum), and intrapartum prophylaxis or treatment given 4 hours or longer before delivery (yes, no) in addition to the following continuous variables: highest maternal intrapartum temperature (centigrade or Fahrenheit), gestational age (weeks and days), and duration of rupture of membranes (hours). A predicted probability per 1,000 live births can be estimated using the calculator (http://newbornsepsiscalculator.org). Several retrospective studies demonstrated that the use of the sepsis calculator in a population of well-appearing neonates (≥34 weeks' gestation) exposed to the clinical maternal diagnosis of chorioamnionitis would have substantially reduced the proportion of neonates undergoing laboratory tests and receiving antimicrobial agents. [202, 207, 208, 209] https://www.cochrane.org/CD005302/PREG_it-better-baby-be-born-immediately-or-wait-labour-start-spontaneously-when-waters-break-or-after-37 - Planned early birth (compared with expectant management) after PROM at term MAY help to reduce infection for women without increasing the need for a caesarean section, and neonatal infection may also be reduced. However, evidence about longer-term effects on children is needed. There is low quality evidence to suggest that planned early birth (with induction methods such as oxytocin or prostaglandins) reduces the risk of maternal infectious morbidity compared with expectant management for PROM at 37 weeks' gestation or later. A review of the available evidence indicates that the placenta does not undergo a true aging change during pregnancy. There is, in fact, no logical reason for believing that the placenta, which is a foetal organ, should age while the other foetal organs do not: the situation in which an individual organ ages within an organism that is not aged is one which does not occur in any biological system. The persisting belief in placental aging has been based on a confusion between morphological maturation and differentiation and aging, a failure to appreciate the functional resources of the organ, and an uncritical acceptance of the overly facile concept of “placental insufficiency” as a cause of increased perinatal mortality. https://fn.bmj.com/content/77/3/F171 https://www.ajog.org/article/S0002-9378(17)30756-1/pdf - MAY contribute to placental ageing and still birth but Not Conclusive evidence, just a hypothesis that certain factors were present in still birth and other placentas https://fn.bmj.com/content/77/3/F171 - Acidosis was attributed more to a reduction in amniotic fluid level than placental degradation “The two most potent causes of increased morbidity in prolonged pregnancy are therefore clearly unrelated to any change in placental functional capacity. Examination of placentas from prolonged pregnancies shows no evidence of any increased incidence of gross placental abnormalities, such as infarcts, calcification, or massive perivillous fibrin deposition. The most characteristic histological abnormality, found in a proportion of cases but certainly not in all, is decreased fetal perfusion of the placental villi.13 The fetal villous vessels are normal in placentas from prolonged pregnancies44 and Doppler flow velocimetry studies have, in general but not unanimously, indicated that there is no increased fetal vascular resistance in such placentas.45-47 The decreased fetal perfusion is therefore probably a consequence of oligohydramnios, because umbilical vein flow studies have shown that fetal blood flow to the placenta is often reduced in cases of oligohydramnios.48 It has to be admitted that the pathophysiology of prolonged pregnancy has not been fully elucidated. It seems, however, quite clear that any ill effects which may befall the foetus in prolonged gestations can not be attributed to placental insufficiency or senescence.” 4. “There was evidence that caesarean birth, perinatal mortality and neonatal intensive care unit admission are reduced by earlier induction of labour (at41+0weeks) compared to later induction (at 42+0weeks or after), and there may also be a reduction in assisted vaginal birth with earlier induction. However, there was not enough evidence to identify the optimal timing of induction more precisely and so the committee made a research recommendation.” Surely a recommendation that does not have enough evidence to determine the effective timing should not be introduced when there are known negative impacts on maternal and infant outcomes with induction. Especially when due dates are not proven to be accurate at all and a blanket approach is going to have a negative impact on a huge number of people’s birth experiences. This is not individualised care. It is not ethical or appropriate to make a recommendation this far reaching and sweeping in nature. Especially considering the findings from Dahlen et al (2021) That showed those who had labour induced had higher rates of epidural/spinal analgesia, caesarean section (except for multiparous women induced between 37-40 weeks), instrumental birth, episiotomy and PPH than women with a similar risk profile who went into labour spontaneously. The children also had higher odds of birth asphyxia, birth trauma, respiratory disorders, major resuscitation at birth and hospitalisation for infection up to the age of 16” Surely this will cost birthing people, babies and the NHS far more than expectant management to 42 weeks. SWEPIS STUDY “It could be argued that the higher mortality in the expectant management group in our study is partly due to lack of routine foetal surveillance with cardiotocography or ultrasonography between 41 and 42 weeks unless there were clinical signs of complications. In general, however, the adverse perinatal outcomes were not higher in the expectant management group in our trial compared with the INDEX trial, and the median gestational age at delivery was higher in the expectant management group in our trial (292 days) than in the INDEX trial (289 days), which could augment mortality rates. No perinatal deaths occurred among women recruited in the Stockholm region, where all women are offered a routine ultrasound scan at 41 weeks (before randomisation), with the aim of identifying women with an increased risk for adverse outcomes. 230 women would need to be induced to save one life. Is this ethical? Cost effective and taking into consideration the long-term health and mental wellbeing impacts that Induction has been shown to cause in several studies. 5. “Support the woman in whatever decision she makes” We welcome this inclusion in the guidance. Especially in light of the evidence from https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-03137-x “Clinicians counselling mothers concerning the need for labour induction should be aware of mothers’ perceptions about birth and engage in true shared decision making in order to avoid the maternal perception of being pressured into labour induction. Experience about people not knowing they had a choice, people being chastise for their decision etc” “One in six (16%) women who planned to have a vaginal birth reported feeling pressure from their provider to have an induction (Table 2), with more women who actually had an induction reporting pressure (27%) than those who did not (7%), Non-Latina white women who had an induction were most likely to report having felt pressured (36%). Other groups reporting significantly higher levels of perceived pressure included women 35 or older (21%), those with at least a college education (21%), those who were obese prior to starting their pregnancy (23%), first time mothers (20%) and women who had reached week 41 of their pregnancy (26%). We also found almost 1 in 4 mothers (24%) who experienced an induction prior to 39 weeks reporting feeling pressure to do so, though most of those cases involved a medical indication. Among mothers with an elective induction at less than 40 weeks, 17% reported feeling pressure to do so. 6. In uncomplicated singleton pregnancies, offer induction of labour at 41+0 10weeks, to take place then or as soon as possible afterwards. [2021] – We strongly object to this addition to the NICE guidance due to lack of evidence as to an appropriate time to offer induction as stated in the guidance. A due date is a construct from blanket recommendations of induction at 41 weeks are not appropriate, proportionate or individualised care. If there are not risk factors, there is not a strong enough body of evidence to recommend this in the guidance as there are mounting studies showing not only the short-term physical and mental negative impacts that induction can have but also the long-term impacts on maternal mental and child physical health. Dahlen et al (2021) Also, due dates are based on a German doctor from 1812 based on a theory that pregnancy lasts 10 lunar months, which was based on the bible. This is NOT evidence-based care. Different people have different cycle lengths, the lunar cycle is in fact 29.5 and not 28 days so the calculation is inaccurate, Parikh’s formula takes cycle length into consideration but doesn’t allow for irregular cycles or differ from the average cycle length. Ultrasound dating may be accurate to within 3-5 days if performed before 12 weeks but the accuracy decreases as the baby grows, the margin for error in the 2nd trimester being 8 days and in the 3rd trimester being 14 days... This is NOT accurate data to be making life changing, sweeping guidelines on. Only 3-5% of babies are born on their estimated due date – This is NOT an accurate dating system. 80% of babies are born 2 weeks either side of the EDD so why not leave the guidelines at offering induction at 42 weeks as there is not sufficient evidence to move the recommended date earlier. It is not ethical or appropriate. 7. Explain to women that the risks associated with a pregnancy continuing beyond 41+0 weeks increase over time, and include: •increased likelihood of caesarean birth •increased likelihood of the baby needing admission to a neonatal intensive care unit 16 •increased likelihood of stillbirth and neonatal death 17 •a possible increased likelihood of assisted vaginal birth (using forceps 18 or ventouse).[2021] If these risks are stated in the NICE guidance, the risks of induction itself also need to be clearly stated. All risks should be given clear indication of their likelihood compared to other outcomes so informed decisions about care can be made. Best practice involves clearly stating numbers and comparisons so people can make an informed decision. Saying an increased risk of something tells you nothing because it could be an 0.1% increased risk or a 99% increased risk and that will change how people make informed decisions about their care If information is not clearly given at appointments and people are coerced into having an induction, this is directly contravening the Hippocratic oath as something that knowingly causes harm is being advocated for without a balanced option of expectant management and the pros and cons for this being stated. 8. Consider induction of labour from 39+0 weeks in women with otherwise uncomplicated singleton pregnancies who are at a higher risk of complications associated with continued pregnancy (for example, BMI 2230kg/m2or above, age 35 years or above, with a black, Asian or minority ethnic family background, or after assisted conception). Why induce early at 39 weeks when trying to prevent continued pregnancy. Normal gestation is 37-42 weeks so offer induction past 42 weeks not before – in uncomplicated singleton pregnancies, why are guidelines suggesting introducing an intervention with known complications and side effects that in your own words can cause a negative experience for birthing people and their babies when you can leave them to birth naturally, which is known to be more beneficial physically and mentally for them. Induction can be offered when people reach continued pregnancy, not well before. Induction in people with increased BMI- Cesarean birth was more common among women with obesity compared with women of normal weight following labour induction (Mantel-Haenszel fixed-effect odds ratio, 1.82; 95% CI, 1.55-2.12; P < .001). Maternal obesity was associated with a longer time to birth, higher doses of prostaglandins, less frequent success of cervical ripening methods, and higher dose of synthetic oxytocin, as well as a longer time to birth after oxytocin use. Therefore why consider induction early when you know that it is more likely to cause problems and be unsuccessful thus wasting money, NHS time and causing upset and trauma to birthing people and their babies. Suggesting that the BMI is used as a standalone tool for measuring risk or as a risk indicator puts racial minorities at increased risk; it is well known that the BMI has a racial bias (NICE has produced research on the subject matter). It is generally weighted towards White people but also ignores variables such as lifestyle, bone density and muscle mass. For instance, an active gym goer who regularly carries out weight bearing exercises is more likely to fall into the overweight/obese range on the index because of their healthy lifestyle will likely result in increased muscle mass and bone density. Using outdated tools such as the BMI as standalone risk indicators increases risk for minority races and people who actively exercise. 35 years or above - “With people who are 35 or older, the care provider’s perception that a person is “high-risk” because they are older might lead to a higher chance of them having an intervention, regardless of the actual need for the intervention. So there needs to be a lot of conclusive, good quality evidence before putting this recommendation in the guidelines as people are likely to be offered induction for no other reason than bias and that is not ethical. There has been one trial in induction of people aged over 35 and it indicated that induction of labour did not improve outcomes or caesarean rates, it was too small to determine if induction could reduce the risk of stillbirth or newborn death. There were 600 participants and 0 deaths. (35/39 trial). Therefore there is not enough evidence to induce people early based soley on their age when they have otherwise uncomplicated singleton pregnancies. This is just ageist and not acceptable to be in the guidance. Black birthing people are 1.5-2 times more likely than white birthing people to have stillbirth at every week of pregnancy (Muglu et al, 2019). Racial health disparities are due to racism in all of its forms, including the effect of prejudice and institutional/systemic racism (Williams and Mohammed, 2013; Bailery at al. 2017). Evidence-based solutions to mitigate racial disparities in pregnancy outcome include doula support and midwife-led models of care (Bohren et al. 2017; Kozhimannil et al. 2016; Thoma et all. 2017; Sandall et al. 2016). Race specific guidance on IOL reinforces racist idea that minority people’s bodies are deficient and are at issue rather than addressing the disparity in quality of care that causes the statistical divergence in risk. This specific guidance gives room for the healthcare system not to pick up mistreatment of monitory patients and allows room for preventable deaths to exist without being picked up. Where is the evidence that putting people from all of these “categories” on a highly medicalised induction pathway will close the disparity gap? This will lead to severely limited choices for these people (no birth centres / homebirths / midwifery-led care - all of which improve outcomes) This recommendation is treating racism with racism - black and brown bodies are not inferior and it is not ethical to induce healthy babies and women with uncomplicated pregnancies at 39 weeks based on the colour of their skin. Inducing black and brown bodied people early will not end the disparities in outcomes The ARRIVE trial stated that a policy of induction was linked to fewer perinatal deaths compared to expectant management, though absolute rates were small (0.4 versus 3 deaths per 1000, “high-certainty evidence”). Overall, the number needed to treat was 544 people with induction to prevent 1 perinatal death. This again is not ethical, practical, or financially viable. The difference in spontaneous birth for ART babies versus spontaneous conception is non-existent beyond 28 weeks so why is routine induction with no complications being suggested? Also the increased risk of still birth is likely to be attributable to the factors that meant that people were not able to get pregnant in the first place, not the actual procedures themselves, so this would not be relevant for same sex couples or surrogates who have undergone Assisted Conception in order to have a baby, so this is not individualised care but a blanket inclusion that does not make logical or ethical sense. Risk of stillbirth and infant deaths after assisted reproductive technology: a Nordic study from the CoNARTas group A A Henningsen et al. Hum Renprod. 2014 May (Pubmed.gov) 9. Expectant management until 37+0 weeks. [2008, updated 2021 Your own evidence review and guidance states: “1.1.10.3 Imprecision and clinical importance of effects Neonatal infections were lower in the immediate delivery group compared with expectant management. When the 2 included studies were meta-analysed, this effect had a high degree of imprecision, and was non-significant, with confidence intervals crossing the line of no effect.” How can one low quality study be used to effect a nationwide policy? Why can expectant management not be continued as long as mother and baby are healthy? https://www.nice.org.uk/guidance/ng195/evidence/c-timing-of-delivery-to-reduce-the-risk-of-earlyonset-neonatal-infection-pdf-9078465712 10. “When making a shared decision, take into consideration the following factors” The decision is NOT shared. The discussion should include the birthing person, options should be presented clearly to them but the decision is their own and not anyone else’s. This needs to be made clear in the guidance as bodily autonomy is very clear in human rights law and needs to be clear in the NICE guidance. 11. Risks for induction also need to be included in this discussion in order to make a balanced point from which the birthing person can make an informed decision. Here only the risks of not inducing have been included. They need to be presented in the guidance as they will be presented in practice. Any risk discussed should be provided in absolute NOT relative terms thereby giving the deciding family a clear indication of what risks they will potentially expose themselves to. 12. induction of labour as soon as possible or expectant management for up to 24 hours. The evidence for a 24 hour window when people who are not at term are offered expectant management sometimes for weeks seems to contradict your own evidence review and guidance which states: “1.1.10.3 Imprecision and clinical importance of effects Neonatal infections were lower in the immediate delivery group compared with expectant management. When the 2 included studies were meta-analysed, this effect had a high degree of imprecision, and was non-significant, with confidence intervals crossing the line of no effect.” How can one low quality study be used to effect a nationwide policy? https://www.nice.org.uk/guidance/ng195/evidence/c-timing-of-delivery-to-reduce-the-risk-of-earlyonset-neonatal-infection-pdf-9078465712 13. a woman has prelabour rupture of membranes at term (at or over 37+04weeks) and has had a positive group B streptococcus test at any time in their current pregnancy, offer immediate induction of labour or caesarean birth.[2021] Surely they should also be offered expectant management, even though there is an increased risk, the choice is still that of the birthing person and is clear in human rights law that their decision should be respected even if it risks theirs or their baby’s life 14. We welcome the inclusion of supporting the birthing person’s decision in accordance with human rights law 15. “That membrane sweeping might make it more likely that labour will start naturally, and so reduces the need for induction of labour” - We do not feel that offering more membrane sweeping is justified with the lack of evidence for effectiveness and the potential increased risk of infection https://www.cochrane.org/CD000451/PREG_membrane-sweeping-induction-labour “Membrane sweeping appears to be effective in promoting labour but current evidence suggests this did not, overall, follow-on to unassisted vaginal births. Membrane sweeping may reduce formal induction of labour. Only three studies reported on women’s satisfaction with membrane sweeping. Women reported feeling positive about membrane sweeping. While acknowledging that it may be uncomfortable, they felt the benefits outweighed the harms and most would recommend it to other women. Further research is needed to confirm our review findings and to identify the ideal time for membrane sweep and whether having more than one sweep would be beneficial. Further information on women’s views is also needed. Evidence Based Birth says: “However, in general, there was a high risk of bias for performance bias due to the fact that all 44 studies did not do any masking in the study. This is sometimes called blinding. Masking would mean that clinicians and researchers did not know who was receiving which treatment, either the actual treatment or the no treatment or the placebo or sham. When no masking is used, as with all of these studies, this may lead to performance bias in which clinicians may be biased towards giving better care to the treatment group in hopes that the treatment will be shown to be effective. For example, if a provider knew someone was in the treatment group for membrane sweeping, they might delay scheduling a formal induction in hopes that the person in the treatment group will go into spontaneous labor on their own. https://evidencebasedbirth.com/updated-evidence-on-the-pros-and-cons-of-membrane-sweeping/ Membrane sweeping IS a form of physical induction and intervention and should be clearly stated as such. We do not naturally or physiologically do this to ourselves so it is therefore an intervention that can disrupt the physiological process of labour. It IS and intervention “The aim of this Cochrane Review is to find out if membrane sweeping is a safe and effective way of inducing labour* at or near term and if it is more effective than the formal methods of induction.” As you can see from this Cochrane review, a sweep is a way of inducing labour. It is a form of physical or mechanical induction Also, membrane sweeping is a medical procedure that requires informed consent so if this medical procedure is NOT to induce labour, what is it for? Sara Wickham makes these observations: https://www.sarawickham.com/articles-2/what-is-a-stretch-and-sweep/ The stretch and sweep is a controversial procedure for a number of reasons. As above, it isn’t as effective as some people would like you to think. it will only work for a few people and it doesn’t bring labour forward by much anyway. It has potential downsides as well as potential benefits. There’s another reason it’s controversial. Some women have found that this procedure is offered or suggested during an antenatal visit without much prior discussion. And, shockingly, sometimes it is suggested while a midwife or doctor is in the middle of a vaginal examination. This is not OK. Neither is it OK for someone to do this without your full consent. A recent review of the literature on this has confirmed some of these things. Roberts et al (2020) found that, “There is a lack of evidence around women’s information needs, decision-making and experiences of membrane sweeping. This is concerning, especially in the context of rising rates of formal induction of labour. Further research is needed to investigate how women are being offered membrane sweeping and what information women need to make informed choices about membrane sweeping to promote spontaneous labour.” Therefore we object to more membrane sweeping being offered, at earlier appointments AND furthermore insist that it is a mechanical form of attempting to induce labour 16. We are encouraged by the inclusion of obtaining informed consent before performing a sweep. It is essential. 17. At antenatal visits from 39+0weeks, offer women a vaginal examination for membrane sweeping. [2008, amended 2021 https://www.sarawickham.com/articles-2/what-is-a-stretch-and-sweep/ The stretch and sweep is a controversial procedure for a number of reasons. As above, it isn’t as effective as some people would like you to think. it will only work for a few people and it doesn’t bring labour forward by much anyway. It has potential downsides as well as potential benefits. There’s another reason it’s controversial. Some women have found that this procedure is offered or suggested during an antenatal visit without much prior discussion. And, shockingly, sometimes it is suggested while a midwife or doctor is in the middle of a vaginal examination. This is not OK. Neither is it OK for someone to do this without your full consent. A recent review of the literature on this has confirmed some of these things. Roberts et al (2020) found that, “There is a lack of evidence around women’s information needs, decision-making and experiences of membrane sweeping. This is concerning, especially in the context of rising rates of formal induction of labour. Further research is needed to investigate how women are being offered membrane sweeping and what information women need to make informed choices about membrane sweeping to promote spontaneous labour.” Therefore, we object to more membrane sweeping being offered, at earlier appointments AND furthermore insist that it is a mechanical form of attempting to induce labour How about increased risk of infection with 5+ vaginal exams – has this been considered alongside the effectiveness/lack thereof of vaginal sweeps? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183634/ 18. “This can include simple analgesia, labour in water and epidural 15analgesia. [2008, amended 2021]” We welcome the inclusion of water as a pain management option and hope that it will actually be provided in trusts as it seems that it is often not offered or facilitated even when requested 19. Offering a rest period if clinically appropriate – We welcome the inclusion of this in the guidance 20. Why is membrane sweeping not considered a form of induction in this guidance when it is a form of physical induction that would not occur naturally? We do not naturally separate our membranes with two fingers; therefore it is a form of physical induction. It is not physiological and is an intervention with associated risks. This should be made clear in the guidance for the reasons stated above. 21. Changes to the recommended time for induction should not be made until there is evidence to show that it would be beneficial changing the recommendation from 42 to 41 weeks. If there is not enough evidence for appropriate timing of induction, which is stated there is not, the change to the guidance should not be made. This evidence is needed BEFORE the recommendation is made, not after, as induction is known to have negative consequences for everyone involved, including financially for the NHS, so this should not be introduced as a guideline until such a time as there is clear evidence. 22. We welcome this research and feel that extra membrane sweeps from 39+0 weeks should not be introduced in the guidance until such a time as there is evidence showing the efficacy and highlighting possible increased risk of infection, risk of rupture of membranes and the further possible cascade of interventions, etc compared to the possible questionable benefits. 23. The committee were aware that certain groups of women may be at higher risk of adverse events with prolonged pregnancy and that these women may benefit from earlier induction. The committee noted that in their knowledge and experience, women from the Black, Asian and minority ethnic family background, women with 25BMI of 30 kg/m2or more, women aged 35 years or more, and women who had assisted conception were at a higher risk of adverse events in a pregnancy that was prolonged beyond term. The committee were aware that this is consistent with national audit data. DRAFT FOR CONSULTATION Inducing labour: NICE guideline DRAFT (May2021) As there was no evidence to identify the optimal timing of induction in these groups the committee made a research recommendation. How the recommendations might affect practice. The recommendations will decrease the gestational age at which induction of labour is offered to prevent prolonged pregnancy, and may increase the number of women who are offered induction. Why induce early at 39 weeks when trying to prevent continued pregnancy? Normal gestation is 37-42 weeks so offer induction past 42 weeks not before – in uncomplicated singleton pregnancies, why are you suggesting introducing an intervention with no known complications and side effects, that in your own words can cause a negative experience for birthing people and their babies when you can leave them to birth naturally, which is known to be more beneficial physically and mentally for them. Induction can be offered when people reach continued pregnancy, not well before. Induction in people with increased BMI - Caesarean birth was more common among women with obesity compared with women of normal weight following labour induction (Mantel-Haenszel fixed-effect odds ratio, 1.82; 95% CI, 1.55-2.12; P < .001). Maternal obesity was associated with a longer time to birth, higher doses of prostaglandins, less frequent success of cervical ripening methods, and higher dose of synthetic oxytocin, as well as a longer time to birth after oxytocin use. Therefore, why consider induction early when you know that it is more likely to cause problems and be unsuccessful thus wasting money, NHS time and causing upset and trauma to birthing people and their babies. 35 years or above - With people who are 35 or older, the care provider’s perception that a person is “high-risk” because they are older might lead to a higher chance of them having an intervention, regardless of the actual need for the intervention. So there needs to be a lot of conclusive, good quality evidence before putting this recommendation in the guidelines as people are likely to be offered induction for no other reason than bias and that is not ethical. There has been one trial in induction of people aged over 35 and it indicated that induction of labour did not improve outcomes or caesarean rates, and it was too small to determine if induction could reduce the risk of stillbirth or newborn death. There were 600 participants and 0 deaths. (35/39 trial). Therefore, there is not enough evidence to induce people early based solely on their age when they have otherwise uncomplicated singleton pregnancies. This is just ageist and not acceptable to be in the guidance. Black birthing people are 1.5-2 times more likely than white birthing people to have stillbirth at every week of pregnancy (Muglu et al, 2019). Racial health disparities are due to racism in all of its forms, including the effect of prejudice and institutional/systemic racism (Williams and Mohammed, 2013; Bailery at al. 2017). Evidence-based solutions to mitigate racial disparities in pregnancy outcome include doula support and midwife-led models of care (Bohren et al. 2017; Kozhimannil et al. 2016; Thoma et all. 2017; Sandall et al. 2016). In our opinion, this recommendation is treating racism with racism - Black and Brown bodies are not inferior and it is not ethical to induce healthy babies and women with uncomplicated pregnancies at 39 weeks based on the colour of their skin. We believe that inducing black and brown bodied people early will not end the disparities in outcomes. The ARRIVE trial stated that a policy of induction was linked to fewer perinatal deaths compared to expectant management, though absolute rates were small (0.4 versus 3 deaths per 1000, “high-certainty evidence”). Overall, the number needed to treat was 544 people with induction to prevent 1 perinatal death. This again is not ethical, practical, financially viable. The difference in spontaneous birth for ART babies versus spontaneous conception is non-existent beyond 28 weeks so why is routine induction with no complications being suggested? Also, the increased risk of still birth is likely to be attributable to the factors that meant that people were not able to get pregnant in the first place, not the actual procedures themselves, so this would not be relevant for same sex couples, or surrogates, who have undergone Assisted Conception in order to have a baby so this is not individualised care but a blanket inclusion that does not make logical or ethical sense. (Risk of stillbirth and infant deaths after assisted reproductive technology: a Nordic study from the CoNARTas group A A Henningsen et al. Hum Renprod. 2014 May (Pubmed.gov)) 24. In women who did not have a positive group B streptococcus test, but who had prelabour rupture of the membranes after 37+0 weeks, the committee were aware that expectant management for 24 hours was an option as the risk of infection to the baby was low. However, after that period, induction should be advised. Your own evidence review and guidance states: “1.1.10.3 Imprecision and clinical importance of effects Neonatal infections were lower in the immediate delivery group compared with expectant management. When the 2 included studies were meta-analysed, this effect had a high degree of imprecision, and was non-significant, with confidence intervals crossing the line of no effect.” How can one low quality study be used to affect a nationwide policy? This is no logical or ethical. https://www.nice.org.uk/guidance/ng195/evidence/c-timing-of-delivery-to-reduce-the-risk-of-earlyonset-neonatal-infection-pdf-9078465712 25. Women with uncomplicated pregnancies should be given every opportunity to go into spontaneous labour. This recommendation has been deleted because the next recommendation states which women with uncomplicated pregnancies should be offered induction, and so the committee agreed this recommendation was unnecessary. *We strongly disagree and believe this recommendation IS necessary and there is not enough evidence for the appropriate timing of induction for a sweeping statement of offering induction at 41 weeks to be made. This is not individualised care The evidence in the latest research by Dahlen et all (2021) clearly indicates that “IOL for non-medical reasons was associated with higher birth interventions, particularly in primiparous women, and more adverse maternal, neonatal and child outcomes for most variables assessed.” This includes long-term health implications for birthing person and children. https://bmjopen.bmj.com/content/11/6/e047040 26. In uncomplicated singleton pregnancies, offer induction of labour at 41+0 weeks, to take place then or as soon as possible afterwards. 1.2.3Explain to women that the risks associated with a pregnancy continuing beyond 41+0 weeks increase over time, and include: increased likelihood of caesarean birth• increased likelihood of admission of the baby to a neonatal intensive care unit• increased likelihood of stillbirth and neonatal death• a possible increased likelihood of assisted vaginal birth (using forceps or ventouse). [2021] *No risks of induction are included here – this is hugely biased presentation of information and does not constitute evidence to make an informed decision about care. There are no relative risks mentioned here and these are often presented in a catastrophic way to coerce agreement into induction rather than offering evidence-based information upon which the birthing person can make an informed decision 27. Induction of labour is appropriate approximately 24 hours after prelabour rupture of the membranes at term. What evidence are you basing this sweeping statement on when your own reviews of the evidence were not conclusive: “1.1.10.3 Imprecision and clinical importance of effects Neonatal infections were lower in the immediate delivery group compared with expectant management. When the 2 included studies were meta-analysed, this effect had a high degree of imprecision, and was non-significant, with confidence intervals crossing the line of no effect.” How can one low quality study be used to effect a nation wide policy? This is unethical and not logical https://www.nice.org.uk/guidance/ng195/evidence/c-timing-of-delivery-to-reduce-the-risk-of-earlyonset-neonatal-infection-pdf-9078465712 28. At antenatal visits from 39+0 weeks, offer women a vaginal examination for membrane sweeping. [2008, amended 2021] https://www.sarawickham.com/articles-2/what-is-a-stretch-and-sweep/ The stretch and sweep is a controversial procedure for a number of reasons. As above, it isn’t as effective as some people would like you to think. it will only work for a few people and it doesn’t bring labour forward by much anyway. It has potential downsides as well as potential benefits. There’s another reason it’s controversial. Some women have found that this procedure is offered or suggested during an antenatal visit without much prior discussion. And, shockingly, sometimes it is suggested while a midwife or doctor is in the middle of a vaginal examination. This is not OK. Neither is it OK for someone to do this without your full consent. A recent review of the literature on this has confirmed some of these things. Roberts et al (2020) found that, “There is a lack of evidence around women’s information needs, decision-making and experiences of membrane sweeping. This is concerning, especially in the context of rising rates of formal induction of labour. Further research is needed to investigate how women are being offered membrane sweeping and what information women need to make informed choices about membrane sweeping to promote spontaneous labour.” Therefore we object to more membrane sweeping being offered, at earlier appointments AND furthermore insist that it is a mechanical form of attempting to induce labour How about increased risk of infection with 5+ vaginal exams – has this been considered alongside the effectiveness/lack thereof of vaginal sweeps? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183634/ 29. Welcome the change to unsuccessful induction 30. Welcome the more consultative nature of the process 31. Welcome the offering of a rest period for more person-centred care 32. We welcome the clearer wording of checking of foetal position before considering induction to improve safety of the procedure
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