Indução com Misoprostol – SCIMED – Análise crítica e fundamentação

Considero que o artigo escrito e publicado pelo Dr. João Cerqueira, na página de facebook Scimed – Ciência Baseada na Evidência, e no blog com o mesmo nome, não está devidamente  fundamentado e, aliás, em várias afirmações o que é utilizado como fundamento científico acaba por ser contraditório com as conclusões do autor. Lamentavelmente, o texto não promove aquilo que hoje sabemos ser a melhor evidência existente, antes pelo contrário, essencialmente por três razões:

1. Desconhecimento factual teórico e prático do uso do Misoprostol – Cytotec e Misodel (Mysodelle) em Obstetrícia.

2. Apesar de terem sido colocados links de referências científicas, por diversas vezes, o que é transmitido aos leitores é diferente do que as respectivas fontes facultam e concluem.

3. Foi dada informação errada relativamente a conteúdos da Biblioteca Cochrane, e omitida informação mais recente.

Com base em diversas citações da publicação em questão, passo a concretizar as três razões, devidamente referenciadas, citando as referências utilizadas no artigo, e acrescentando as que sustentam esta análise.

1. Desconhecimento factual teórico e prático do uso do Misoprostol – Cytotec e Misodel (Mysodelle) em Obstetrícia

1.1. Misoprostol Off-Label em Urologia e Pediatria/Cirurgia Pediátrica

1.2.  Misoprostol registado para uso obstétrico – Misodel(Mysodelle) e Angusta

https://www.nice.org.uk/advice/esnm38/chapter/Estimated-impact-for-the-NHS

“Estimated usage

It is difficult to provide estimated usage based on the available data.

According to NHS maternity statistics, 671,255 babies were delivered in NHS hospitals in England, 2012−2013. When the method of onset of labour was known, 64% of deliveries were spontaneous onset; 12.8% were medically induced; 12.7% were caesarean onset; 5.5% were medically and surgically induced; and 5.0% were surgically induced (Health and Social Care Information Centre 2013).

Currently, vaginal prostaglandin E2 is the preferred method of induction of labour unless there are specific clinical reasons for not using it (Induction of labour, NICE clinical guideline 70). The manufacturer of the misoprostol vaginal insert, Ferring Pharmaceuticals, estimates that two-thirds of the 23.3% of inductions (medical and/or surgical) are eligible for medical induction with vaginal prostaglandin E2, suggesting that the estimated patient population for medical induction of labour in England is about 100,000 women per year.

It is unclear how many of these women might receive the misoprostol vaginal insert rather than vaginal prostaglandin E2, particularly because the contraindications for the 2 drugs are similar.”

 […] The PK/PD study has several deficiencies that makes firm conclusion difficult with regards to PK. The PD outcomes offer some reassurance that Cytotec and Angusta have similar PD properties. 29,000 women have been treated for the induction of labour in Denmark, Norway and Finland with Angusta in a compassionate use program. Unfortunately, no efficacy data are available from this programme. […]

Misoprostol used for the induction of labour can cause uterus hyper-stimulation. As a possible consequence of this caesarean section, serious neonatal morbidity or perinatal death, serious maternal morbidity or death, uterine rupture and meconium staining could occur. Spontaneous adverse event reports are available from the 29,000 women who have been exposed to Angusta in the compassionate use program. These show overall, that the reported adverse events resemble the observed adverse events in the clinical studies included in the Cochrane review.

“Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.”

“Uma utilização fora das indicações autorizadas (off-label): um medicamento utilizado fora das indicações autorizadas (off-label) é, por definição, um medicamento utilizado de um modo diferente do autorizado. Por exemplo, um medicamento pode ser dado para uma doença diferente ou numa dose diferente da indicada nos documentos da sua autorização. Assim, a utilização fora das indicações autorizadas (off-label) só se aplica a medicamentos que já estão autorizados. O uso compassivo só se aplica a medicamentos que ainda não estão autorizados para qualquer doença.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4885466/?fbclid=IwAR2oWjSOv03A4qlV3kue85ggWjNWGjufi4ChGYzwrpPxHLVTJ8Aren3JMls

“Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?”

 “[…]Angusta is produced in India and is not a registered drug in Europe.9 In order to use a non-registered drug as common treatment, a compassionate user permit is required, and thus, after the first permit for Angusta was launched by the Danish Health and Medicines Authorities in 2012, 18 of the 22 Danish obstetric departments had a compassionate user permit by June 2013.10 Such a launch of compassionate user permits to several hospitals is the first example of Danish authorities allowing the routine use of a non-registered drug in a situation where a registered drug is available.[…]

1.3. Misodel em Portugal

1.4. Asma e pré-eclâmpsia

“Misoprostol and the debate over off‐label drug use”
https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/j.1471-0528.2004.00490.x
No artigo, podemos verificar que apenas a palavra pré-eclâmpsia é referida e neste contexto:
“This is especially true in Africa where three of the biggest causes of maternal mortality—haemorrhage, septic abortion and pre‐eclampsia—could each be reduced with easy access to a stable and cheap prostaglandin.”

Asthma in pregnancy: a review

“In labour continue with asthma medications if they are required. If the woman has used systemic hydrocortisone, give 100 mgs 8th hourly during labour, maintain hydration, favour lumbar epidural analgesia and avoid bronchoconstricting agents (prostaglandin F2α). Prostaglandin E1 or E2 can be used. “

Prostaglandins to Induce Labor in Women with Asthma

Can prostaglandin be used  in an asthmatic patient?

1.5. Recomendações Misoprostol em Obstetrícia

https://www.nice.org.uk/guidance/cg70

“The NICE clinical guideline on induction of labour (NICE clinical guideline 70) states that Misoprostol (a prostaglandin E1) should only be offered as a method of induction of labour to women who have had an intrauterine fetal death or in the context of a clinical trial. If induction of labour is clinically justified, NICE states that vaginal prostaglandin E2 (dinoprostone gel, tablet or controlled-release insert) is the preferred method, unless there are specific clinical reasons for not using it (in particular the risk of uterine hyperstimulation).”

https://www.health.qld.gov.au/__data/assets/pdf_file/0020/641423/g-iol.pdf

“· Compared with placebo, Misoprostol (sustained release vaginal pessary, vaginal tablet, buccal/sublingual and oral tablet) had higher odds of uterine hyperstimulation with FHR changes than 31 other active interventions (180 studies)86 · Not currently recommended for IOL where a live birth is expected

o Not included on the Queensland Health List of Approved Medicines (LAM) for IOL with a viable baby

  1. Alfirevic Z, Keeney E, Dowswell T, Welton NJ, Medley N, Dias S, et al. Methods to induce labour: a systematic review, network metaanalysis and cost-effectiveness analysis. BJOG 2016;123(9):1462-70.

https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/j.1447-0756.2011.01653.x?fbclid=IwAR3TMEr9f0Iw3lvePwmTTlKzTpZTmSQ5Gd5e9mXBWSLbeGBL2WUfcBj6Fno

CQ412: How should labor be induced?

Answer 1. Adhere strictly to the ‘Guidelines for the use of uterotrophic drugs in Japan 2011’ regarding the use of uterotrophic drugs, such as i.v. oxytocin, i.v. prostaglandin F2α, and oral prostaglandin PGE2 tablets. (A)

1.6. Reino Unido e o Mysodelle

https://clinicaltrials.gov/ct2/show/results/NCT01127581?view=results

“Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (EXPEDITE). Sponsor:Ferring Pharmaceuticals”

https://www.nice.org.uk/advice/esnm38/chapter/Estimated-impact-for-the-NHS

“Induction of labour: Misoprostol vaginal delivery system ”

“Estimated usage

It is difficult to provide estimated usage based on the available data.

According to NHS maternity statistics, 671,255 babies were delivered in NHS hospitals in England, 2012−2013. When the method of onset of labour was known, 64% of deliveries were spontaneous onset; 12.8% were medically induced; 12.7% were caesarean onset; 5.5% were medically and surgically induced; and 5.0% were surgically induced (Health and Social Care Information Centre 2013).

Currently, vaginal prostaglandin E2 is the preferred method of induction of labour unless there are specific clinical reasons for not using it (Induction of labour, NICE clinical guideline 70). The manufacturer of the misoprostol vaginal insert, Ferring Pharmaceuticals, estimates that two-thirds of the 23.3% of inductions (medical and/or surgical) are eligible for medical induction with vaginal prostaglandin E2, suggesting that the estimated patient population for medical induction of labour in England is about 100,000 women per year.

It is unclear how many of these women might receive the misoprostol vaginal insert rather than vaginal prostaglandin E2, particularly because the contraindications for the 2 drugs are similar.”

1.7. Misoprostol e a nossa DGS

https://www.ers.pt/pages/419

“1. O que é o consentimento informado?

Entende-se por consentimento informado a autorização esclarecida prestada pelo utente antes da submissão a determinado ato médico, qualquer ato integrado na prestação de cuidados de saúde, participação em investigação ou ensaio clínico. Esta autorização pressupõe uma explicação e respetiva compreensão quanto ao que se pretende fazer, o modo de atuar, razão e resultado esperado da intervenção consentida.

Em regra, qualquer intervenção no domínio da saúde apenas pode ter lugar após prestação do consentimento livre e esclarecido pelo destinatário da mesma. Ou seja, o utente deve receber previamente a informação adequada quanto ao objetivo, natureza da intervenção, consequências, riscos e alternativas.”

http://www.jornalmedico.pt/opiniao/29635-nuno-gundar-da-cruz-uso-off-label-de-medicamentos.htm

O uso off-label de medicamentos verifica-se quando o médico prescreve uma determinada terapêutica para um estado clínico que não consta da bula do medicamento (ou, em bom rigor, da autorização de introdução no mercado).

Importa, antes do mais, esclarecer o seguinte: ao contrário do que poderia julgar-se à primeira vista, a circunstância de um médico prescrever um medicamento para um estado clínico diferente do que consta da bula não constitui, necessariamente, uma situação de violação das boas práticas médicas.

Com efeito, a posição dos especialistas sobre esta matéria, nomeadamente da Prof. Dra. Vera Lúcia Raposo, é a de que a prescrição off-label de medicamentos será lícita quando, designadamente:

(i) contar com o consentimento informado do paciente, devendo, neste caso, o grau de informação providenciado pelo médico ser especialmente rigoroso e completo;

(ii) aportar efeitos benéficos para o paciente;

(iii) resultar de uma decisão livre, autónoma (e, atrevo-me a dizer, consciente e ponderada) do médico;

(iv) a decisão do médico for baseada em dados científicos convincentes;

(v) não existir qualquer outro medicamento autorizado e com indicação terapêutica para aquele estado clínico.

É essencial que se verifique um consentimento informado do paciente. De facto, a prática de actos médicos apenas é lícita quando se verifica o consentimento livre e esclarecido do paciente. É o que resulta da Carta dos Direitos Fundamentais da União Europeia e da Convenção Europeia dos Direitos do Homem e da Biomedicina.”

“Many online guideline websites promote themselves as “evidence based,” but few have explicit links to research findings. [8] If they don’t have in-line references to relevant research findings, dismiss them. If they have, you can judge the strength of the commitment to evidence to support inference, checking whether statements are based on high-quality vs low-quality evidence using alternative 1 explained above.

Unfortunately, most guidelines have serious limitations or are outdated. [9], [10] The exercise of locating and appraising the best guideline is time consuming. This is particularly challenging for generalists addressing questions from different conditions or diseases.”

2. Apesar de terem sido colocados links de referências científicas, por diversas vezes, o que é transmitido aos leitores é diferente do que as respectivas fontes facultam e concluem.

2.1. Reino Unido, Misoprostol e alterações das recomendações do NICE

https://www.ncbi.nlm.nih.gov/pubmed/27001034

“Methods to induce labour: a systematic review, network meta-analysis and cost-effectiveness analysis.” BJOG. 2016 Aug

https://www.ncbi.nlm.nih.gov/pubmed/25656228

“Labour induction with prostaglandins: a systematic review and network meta-analysis.” BMJ. 2015 Feb

https://www.ncbi.nlm.nih.gov/pubmed/25656228

“Labour induction with prostaglandins: a systematic review and network meta-analysis.” BMJ. 2015 Feb

“Low dose(<50 µg) titrated oral Misoprostol solution had the lowest probability of caesarean section, whereas vaginal Misoprostol (≥50 µg) had the highest probability of achieving a vaginal delivery within 24 hours. These findings have important implications for a series of current national and international guidelines for induction of labour and future research in this area.”

https://www.ncbi.nlm.nih.gov/pubmed/27001034

“Methods to induce labour: a systematic review, network meta-analysis and cost-effectiveness analysis.” BJOG. 2016 Aug

“Before any recommendations can be made about which intervention(s) are the safest, most effective and most cost‐effective for third‐trimester induction of labour, more research is needed. The considerable uncertainty in our findings, particularly in cost‐effectiveness estimates, points the way for further research When induction of labour is clinically indicated, a placebo or no intervention arm in a trial may not be feasible or ethical. Given the relatively high rates of hyperstimulation with buccal/sublingual misoprostol, we suggest that titrated low‐dose oral misoprostol should be used as a comparator, and future RCTs should be powered to detect a method that is more cost‐effective. Clearly, the fact that oral misoprostol is unlicensed for labour induction with virtually no pharmacokinetic data, poses a considerable research governance challenge.”

 

2.2. Dosagem e segurança

https://www.ajog.org/article/S0002-9378(18)30249-7/pdf
“Induction of labor using one dose vs multiple doses of Misoprostol: a randomized controlled trial”

https://www.ncbi.nlm.nih.gov/pubmed/25656228

“Labour induction with prostaglandins: a systematic review and network meta-analysis.” BMJ. 2015 Feb

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5638087/

“Simplifying oral Misoprostol protocols for the induction of labour”

https://www.ajog.org/article/S0002-9378(18)30249-7/pdf

“Induction of labor using one dose vs multiple doses of Misoprostol: a randomized controlled trial”

“In this first randomized controlled trial in the literature to compare a single with a multiple dosing of Misoprostol, we found that the 1-dose regimen is an acceptable alternative for the induction for labor, especially for multiparous women and for patients with a Bishop score >4 after the first dose.”

https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1111/1471-0528.12935

“Balancing the efficacy and safety of Misoprostol: a meta-analysis comparing 25 versus 50 micrograms of intravaginal Misoprostol for the induction of labour”

“Conclusions Although 50 micrograms of intravaginal Misoprostol may be more efficacious, safety concerns make the 25-microgram dose preferable.

https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1111/1471-0528.12935

“Balancing the efficacy and safety of Misoprostol: a meta-analysis comparing 25 versus 50 micrograms of intravaginal Misoprostol for the induction of labour”

“Conclusions Although 50 micrograms of intravaginal Misoprostol may be more efficacious, safety concerns make the 25-microgram dose preferable.

Crítica a este estudo (a) https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.13020

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5638087/

“Simplifying oral Misoprostol protocols for the induction of labour”

“[…] Titrated low‐dose oral Misoprostol was identified as likely to be the most cost‐effective method, and also had a favourable safety profile.[…] ‘Oral Misoprostol’, however, is not a single entity and systematic reviewers have struggled to cope with the wide variation in protocols (Table 1).[…]Is there evidence to suggest that any of these protocols are superior? Subgroup analyses of some important clinical outcomes show a clear dose effect. For example, when comparing oral Misoprostol with dinoprostone, the rate of hyperstimulation increases as the initial dose rises from 25 to 200 μg.4 It would therefore appear that there are safety benefits of using doses of 20–25 μg, even if they may result in a slower induction process. This is supported by a systematic review of just the studies that used 20–25 μg of oral Misoprostol, which found lower caesarean section and lower hyperstimulation rates compared with standard induction methods.[…]

https://www.cochrane.org/CD001338/PREG_oral-misoprostol-induction-labour

“Oral Misoprostol is effective at inducing (starting) labour. It is more effective than placebo, as effective as vaginal Misoprostol and vaginal dinoprostone, and results in fewer caesarean sections than oxytocin. However, there are still not enough data from randomised controlled trials to determine the best dose to ensure safety.[…] Where oral Misoprostol is used, evidence suggests that an appropriate dose may be 20 to 25 mcg in solution. Given that safety is the primary concern, the evidence supports the use of oral regimens over vaginal regimens.[…]”

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/misoprostol-marketed-cytotec-information

Misoprostol (marketed as Cytotec) Information. FDA ALERT – Risks of Use in Labor and Delivery

“This Patient Information Sheet is for pregnant women who may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.

There can be serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.”

2.3. Preço e “vantagens”

Vaginal misoprostol for cervical ripening and induction of labour.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5638087/

“Simplifying oral Misoprostol protocols for the induction of labour”

https://www.ncbi.nlm.nih.gov/pubmed/20927722

AUTHORS’ CONCLUSIONS:

Vaginal misoprostol in doses above 25 mcg four-hourly was more effective than conventional methods of labour induction, but with more uterine hyperstimulation. Lower doses were similar to conventional methods in effectiveness and risks. The authors request information on cases of uterine rupture known to readers. The vaginal route should not be researched further as another Cochrane review has shown that the oral route of administration is preferable to the vaginal route. Professional and governmental bodies should agree guidelines for the use of misoprostol, based on the best available evidence and local circumstances.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5638087/

“[…]Simplifying oral Misoprostol protocols for the induction of labour”

‘Oral Misoprostol’, however, is not a single entity and systematic reviewers have struggled to cope with the wide variation in protocols (Table 1). Published randomised trials have a wide variety of Misoprostol doses (20–200 μg) and frequency of administration (1–6 hourly).[…]

2.4. Misoprostol e a cesariana anterior

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678051/

Misoprostol for Labour Induction after Previous Caesarean Section – Forever a “No Go”?Misoprostol for Labour Induction after Previous Caesarean Section – Forever a “No Go”?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678051/

Misoprostol for Labour Induction after Previous Caesarean Section – Forever a “No Go”?

“Medical induction of labour after previous caesarean section is regarded as an independent risk factor for uterine rupture, whether using oxytocin, PGE2 or Misoprostol. We aimed to critically re-evaluate the “historical” literature on the use of Misoprostol in this setting with respect to the current state of knowledge, thus hoping to end years of stagnation and stimulate discussion to initiate new trials on the subject. We did not aim to declare the association of Misoprostol and uterine rupture as harmless, nor did we intend to propagate the unconsidered use of Misoprostol after previous caesarean; current guidelines should be regarded as valid and unchanged in this issue. Rather, after detailed examination of trials to date, we believe we have shown clearly that the evidence behind current guidelines against the use of Misoprostol is insufficient. The question remains: should these guideline recommendations simply be accepted and fixed for the future or is there a need for the generation of new data?”

2.5. Misoprostol e a taquissistolia

“Misoprostol vaginal delivery system (Mysodelle): reports of excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment”

“Tachysystole Following Cervical Ripening and Induction of Labor Is Not Associated with Adverse Outcomes”

“Misoprostol vaginal delivery system (Mysodelle): Reports of excessive uterine tachysystole (contractions) that may not respond to tocolytic treatment”

“Acute tocolysis for uterine tachysystole or suspected fetal distress”

[…]There is insufficient evidence to determine the effects of tocolytics for uterine tachysystole or suspected fetal distress during labour. The clinical significance for some of the improvements in measures of fetal wellbeing with tocolytics is unclear. The sample sizes were too small to detect effects on neonatal morbidity, mortality or serious adverse effects. […]

Tachysystole in term labor: incidence, risk factors, outcomes, and effect on fetal heart tracings.

[…]Use of oxytocin or misoprostol, an epidural, hypertension, and induction of labor were associated with an increased risk of TS. We found a doubling of TS events with any oxytocin, a dose-response correlation between oxytocin and TS, FHR changes occurring in a quarter of TS events and, finally, that presence of TS increases the chance of composite neonatal morbidity.[…]

2.6. A taxa de mortalidade infantil e os obstetras portugueses

3. Foi dada informação errada relativamente a conteúdos da Biblioteca Cochrane, e omitida informação mais recente.

3.1. Misoprostol vaginal vs dinosprosterona

https://www.ncbi.nlm.nih.gov/pubmed/20927722

“Vaginal misoprostol for cervical ripening and induction of labour.”

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000941.pub2/full

“Vaginal misoprostol for cervical ripening and induction of labou.”

“Authors’ conclusions

Vaginal misoprostol in doses above 25 mcg fourhourly was more effective than conventional methods of labour induction, but with more uterine hyperstimulation. Lower doses (25 mcg fourhourly or less) were similar to conventional methods in effectiveness and risks. The authors request information on cases of uterine rupture known to readers. The vaginal route should not be researched further as another Cochrane review has shown that the oral route of administration is preferable to the vaginal route. Professional and governmental bodies should agree guidelines for the use of misoprostol, based on the best available evidence and local circumstances.”

3.2. Misoprostol e segurança em cesariana prévia

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678051/

Misoprostol for Labour Induction after Previous Caesarean Section – Forever a “No Go”?Misoprostol for Labour Induction after Previous Caesarean Section – Forever a “No Go”?

https://www.cochrane.org/CD001338/PREG_oral-Misoprostol-induction-labour

“Oral Misoprostol for induction of labour”. 2014

“[…]Although there were no reported uterine ruptures in the 160 women in this review who were induced with Misoprostol having had a previous caesarean sections, observational studies suggest that the uterine rupture rate is high with Misoprostol, even when used in low doses. We therefore continue to recommend that it should not be used for women with previous caesarean section scars.[…]”

  1. https://www.cochrane.org/CD009792/PREG_induction-methods-women-who-have-had-prior-caesarean-birth

Induction methods for women who have had a prior caesarean birth”. 2017

[…] Vaginal Misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received Misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. […]

Implications for practice

There is insufficient information available from randomised controlled trials to inform clinical decisions regarding the optimal method of induction of labour in women with a prior caesarean birth. For women with an unfavourable cervix who require induction of labour, the risks and benefits of mechanical and pharmacologic options of cervical ripening, as well as labour induction and augmentation need to be considered. Whilst the data in this review are insufficient to inform practice in terms of the best method of induction for women with a prior caesarean, it is important to highlight that one study, which used Misoprostol, was stopped early due to serious complications associated with its use.[…]”

Resumindo…

” “[…] na ausência de condições de risco de vida para a mãe e o bebé, não há consenso sobre o que constitui um risco aceitável de indução do parto. É provável que a maioria dos pais e dos clínicos não estejam preparados para aceitar um aumento dos resultados adversos de 0,5% para 1%. De facto, é de esperar que as mulheres estejam dispostas a estar mais tempo nas salas de parto, se isso significar um parto mais seguro, mas há uma assinalável falta de dados sobre isso. Na verdade, a maioria dos estudos nesta revisão não avaliou as opiniões das mulheres nem os índices de satisfação. […] Os dados actualmente disponíveis estão longe de ser suficientes para lidar com a questão da segurança quer do processo de indução, quer, a longo prazo, de seguimento dos bebés expostos ao misoprostol.
É importante reiterar aqui que ‘nenhuma evidência de diferença’, nesta revisão da Cochrane, não significa ‘evidência de nenhuma diferença’. Por outras palavras, quanto mais dados randomizados ficarem disponíveis, mais visíveis se tornam as pequenas mas importantes diferenças clínicas entre os vários regimes, isto é, mais estatisticamente significativas se tornam. […] Para avaliar a questão dos efeitos adversos fetais, são necessários estudos ou meta-análises com força suficiente, com uma amostra além das 30 mil mulheres. Até se ter os recursos logísticos e financeiros disponíveis para se conduzir tais estudos, deve-se encontrar alternativas para avaliar os riscos. Uma hipótese é fazer-se o registo das mulheres que foram induzidas com misoprostol.”

Cochrane Library
Oral Misoprostol for induction of labor

( tradução dos dois últimos parágrafos da secção “Risk of Induction”)

April 2014

PDF da análise crítica
Misoprostol em Induções de Parto – Fundamentação
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