Evidence map›Paper›PMID 22769055›Full record

ArticleBMC pregnancy and childbirth2012

Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make?

Wilfrido León, Jill Durocher, Gustavo Barrera, Ernesto Pinto, Beverly Winikoff

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC pregnancy and childbirth, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01080846 (Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01080846 nacompletednot on this map

Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

TypeinterventionalSponsorGynuity Health ProjectsRan2010 to 2010Enrolled50ConditionsPostpartum HemorrhageArmsMisoprostol
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Wilfrido LeónHospital Gineco–Obstétrico Isidro Ayora, Quito, Ecuador.
Jill Durocher
Gustavo Barrera
Ernesto Pinto
Beverly Winikoff
Gynuity Health Projects · USHospital Gineco Obstétrico Isidro Ayora

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundShivering and fever are common side effects of misoprostol. An unexpectedly high rate of fever above 40°C was documented among Ecuadorian women given treatment with 800mcg of sublingual misoprostol to manage postpartum hemorrhage (PPH) (36%). Much lower rates have been reported elsewhere (0-9%).

methodsFrom February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine whether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (≥40°C). Rates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in Ecuador following PPH treatment with 800mcg sublingual misoprostol.

resultsThe 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50; 16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the 600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases of delirium/altered sensorium were reported with the 600mcg dose and women's assessment of severity/tolerability of shivering and fever was better with the lower dose.

conclusions600mcg sublingual misoprostol was found to decrease the occurrence of high fever among Ecuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this treatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other populations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following sublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger trials to confirm the efficacy of lower dosages may be justified.

trial registrationClinical trials.gov, Registry No. NCT01080846.

Indexed as

Administration, SublingualAdolescentAdultDose-Response Relationship, DrugFemaleFeverHumansMisoprostolPilot ProjectsPostpartum HemorrhagePregnancyShiveringUterine InertiaYoung AdultMisoprostol

Identifiers

PMID22769055
PMCPMC3434079
OpenAlexW2050788289

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.