Side effects of oral misoprostol for the prevention of postpartum hemorrhage: Results of a community-based randomised controlled trial in rural India

Patted, Suresh; Goudar, Shivaprasad S.; Naik, Vijaya A.; Bellad, Mrutyunjaya; Edlavitch, Stanley A.; Kodkany, Bhala; Patel, Ashlesha; Chakraborty, Hrishikesh; Derman, Richard J.; Geller, Stacie E.

doi:10.1080/14767050802452309

Cited by 30 publications

(34 citation statements)

References 15 publications

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“…Récemment, certains auteurs ont montré l'efficacité du misoprostol, analogue de la prostaglandine E1, dans la prévention de l'hémorragie de la délivrance [2,3]. Il existe actuellement une littérature abondante sur l'apport du misoprostol dans la prévention de l'hémorragie de la délivrance en cas d'accouchement par voie basse [6,[8][9][10][11]. Il ressort clairement de l'analyse de ces travaux que l'ocytocine est sans conteste plus efficace que le misoprostol dans la prévention de l'hémorragie de la délivrance.…”

Section: Discussionunclassified

“…Il ressort clairement de l'analyse de ces travaux que l'ocytocine est sans conteste plus efficace que le misoprostol dans la prévention de l'hémorragie de la délivrance. Cette dernière molécule demeure, en revanche, plus efficace qu'un placebo dans la prévention de l'hémorragie de la délivrance et donc son utilisation pourrait être réservée aux situations d'absence de disponibilité de l'ocytocine et notamment dans les accouchements non médicalement assistés en cas de difficulté d'accès aux centres de santé et structures hospitalières comme dans les pays en voie de développement [6,8,9]. Les posologies de 600 mcg et 400 mcg per os utilisées à cet effet paraissent équivalentes en attendant les résultats d'essais prospectifs comparant ces deux doses [6].…”

Section: Discussionunclassified

“…Il est décrit que la voie orale est la plus pourvoyeuse d'effets indésirables surtout de type gastro-intestinaux (nausées, vomissements, diarrhée) [8,14,16,17], la voie sublinguale, en évitant le premier passage hépatique, offre une absorption rapide du misoprostol à l'origine d'un pic sérique immédiat et d'un taux sérique optimal, avec des effets secondaires qui ne semblent pas plus importants que pour la voie orale. Il existe un seul essai ayant comparé ces deux voies [13] mais la taille réduite de cet essai ne permet pas de tirer des conclusions définitives.…”

Section: Discussionunclassified

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Intérêt du misoprostol dans la prévention de l’hémorragie du post-partum immédiat en cas de césarienne : essai prospectif randomisé

Fékih

Jnifene

Fathallah

et al. 2009

Journal de Gynécologie Obstétrique et Biologie de la Reproducti

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Section: Discussionunclassified

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Intérêt du misoprostol dans la prévention de l’hémorragie du post-partum immédiat en cas de césarienne : essai prospectif randomisé

Fékih

Jnifene

Fathallah

et al. 2009

Journal de Gynécologie Obstétrique et Biologie de la Reproducti

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“…One trial comparing 600 micrograms oral versus 600 micrograms rectal misoprostol confirmed that the oral dose resulted in significantly higher rates of shivering (76 versus 54%) and fever (9 versus 1%) 7. Nevertheless, the reported rates of shivering and fever vary greatly in the literature 10. For example, rates of shivering and fever following a prophylactic oral dose of 600 micrograms of misoprostol range from 18 to 71% and from 1 to 38%, respectively 7,11,12.…”

Section: Introductionmentioning

confidence: 99%

High fever following postpartum administration of sublingual misoprostol

Durocher

Bynum

León³

et al. 2010

BJOG

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ObjectiveTo explore what triggers an elevated body temperature of ≥40.0°C in some women given misoprostol, a prostaglandin E1 analogue, for postpartum haemorrhage (PPH).DesignPost hoc analysis.SettingOne tertiary-level hospital in Quito, Ecuador.PopulationA cohort of 58 women with a fever of above 40°C following treatment with sublingual misoprostol (800 micrograms) for PPH.MethodsSide effects were documented for 163 Ecuadorian women given sublingual misoprostol to treat their PPH. Women’s body temperatures were measured, and if they had a fever of ≥40.0°C, measurements were taken hourly until the fever subsided. Temperature trends were analysed, and the possible physiological mechanisms by which postpartum misoprostol produces a high fever were explored.Main outcome measuresThe onset, duration, peak temperatures, and treatments administered for cases with a high fever.ResultsFifty-eight of 163 women (35.6%) treated with misoprostol experienced a fever of ≥40.0°C. High fevers followed a predictable pattern, often preceded by moderate/severe shivering within 20 minutes of treatment. Body temperatures peaked 1–2 hours post-treatment, and gradually declined over 3 hours. Fevers were transient and did not lead to any hospitalisation. Baseline characteristics were comparable among women who did and did not develop a high fever, except for known previous PPH and time to placental expulsion.ConclusionsAn unexpectedly high rate of elevated body temperature of ≥40.0°C was documented in Ecuador following sublingually administered misoprostol. It is unclear why temperatures ≥40.0°C occurred with a greater frequency in Ecuador than in other study populations using similar treatment regimens for PPH. Pharmacogenetic studies may shed further light on variations in individuals’ responses to misoprostol.

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“…After exclusion criteria were applied, seven studies remained (Figure 1), of which two were duplicate. Derman 13 and Patted 17 reported the results of their study in two separate papers: the former reporting effectiveness of misoprostol and the Programme 7. The EU is not responsible for views advanced here latter reporting side-effects experienced.…”

Section: Results Of Literature Searchmentioning

confidence: 99%

Rethinking WHO guidance: review of evidence for misoprostol use in the prevention of postpartum haemorrhage

2012

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SUMMARYThis article describes and critically appraises clinical trials assessing misoprostol effectiveness in preventing primary postpartum haemorrhage (PPH) in home and community settings in low-and middle-income countries. Of 172 identified studies of misoprostol use in labour only six fulfilled the inclusion criteria. All trials used 600μg misoprostol in the intervention arm; three assessed misoprostol alongside components of active management of the third-stage labour (AMTSL), two used expectant management of labour and one allowed birth attendants to choose management practice. The three AMTSL studies showed no significant differences in PPH incidence or referral to higher centres and only one study showed significant decrease in severe PPH using misoprostol. One expectant management study and the choice of management by birth attendants study found significant decreases in PPH incidence with misoprostol. All studies showed significantly increased risk of shivering with misoprostol. Studies were biased by use of alternative uterotonics in the control arm, confounding management practices, and subjective assessment and, with one exception, exclusion of high-risk women. PPH incidence fell in both the control and intervention groups in both the landmark papers that informed the World Health Organization (WHO) decision to admit misoprostol to the Essential Medicines List. This suggests factors other than misoprostol use are crucial. Current evidence does not support misoprostol use in home and community settings in low-and middle-income countries for PPH prevention. WHO should rethink its recent decision to include misoprostol on the Essential Medicines List.

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Side effects of oral misoprostol for the prevention of postpartum hemorrhage: Results of a community-based randomised controlled trial in rural India

Abstract: Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.

Cited by 30 publications

References 15 publications

Intérêt du misoprostol dans la prévention de l’hémorragie du post-partum immédiat en cas de césarienne : essai prospectif randomisé

Intérêt du misoprostol dans la prévention de l’hémorragie du post-partum immédiat en cas de césarienne : essai prospectif randomisé

High fever following postpartum administration of sublingual misoprostol

Rethinking WHO guidance: review of evidence for misoprostol use in the prevention of postpartum haemorrhage

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