Evidence map›Paper›PMID 32116725›Full record

ArticleFrontiers in pharmacology2020

A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration.

Mahdi Amini, Margareta Reis, Dag Wide-Swensson

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

NCT02516631 phase1completednot on this map

A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following Single Oral or Sublingual Administration and Comparison of Safety of the Two Formulations Following Repeat Dosing Until Labour

TypeinterventionalSponsorRegion SkaneRan2014 to 2016Enrolled72ConditionsLabour, InducedArmsAngusta™, Cytotec®
NCT05424445 phase3completednot on this mapstarted 2022, after this paper: background citation

Orally Administered Misoprostol Solution (Cytotec®) Versus Orally Administered Misoprostol as a Tablet (Angusta®) for Induction of Labor in Women With Mixed Parity and an Unfavorable Cervix, a Randomized Controlled Trial.

TypeinterventionalSponsorKarolinska InstitutetRan2022 to 2023Enrolled884ConditionsInduced Vaginal DeliveryArmsMisoprostol
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Observational
  4. Article
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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

3 authors at 1 institution in 1 country.

Mahdi AminiDepartment of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden.
Margareta ReisDepartment of Clinical Chemistry and Pharmacology, Skåne University Hospital, Lund, Sweden.
Dag Wide-SwenssonDepartment of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden.
Skåne University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMisoprostol (Cytotec) was primarily made for treating gastric ulcers. However today it is mostly used for abortion, treating postpartum hemorrhage, and for induction of labor. The tablet contains 200 µg of misoprostol, yet the dosages used for induction of labor are much smaller (25-50 µg), leading to uncertainty of dosage in daily use.

aimTo evaluate and compare the relative bioavailability of two misoprostol products (Angusta 25 µg and Cytotec 200 µg tablets) administered orally or sublingually given in a daily clinical setting to women admitted for induction of labor at term.

methodsWomen carrying a live, singleton fetus in a cephalic position and with a gestational age between 259 and 296 days were included. Blood samples were collected at 0, 5, 10, 20, 30, 40, 50, 75, 100, 120, 180, and 240 minutes. A serum analytical assay was performed and pharmacokinetic parameters were calculated. Patients were assigned to one of three groups.

resultsA total of 72 patients were included. No significant differences demographic characteristics were found. The ratios for AUC, AUC (

conclusionThe relative bioavailability between Angusta and Cytotec could not be confirmed as being equal at the 25 µg or 50 µg level because the 90% CI-values when comparing the ratios for AUC, AUC CLINICAL

trial registrationwww.ClinicalTrials.gov, identifier NCT02516631.

Indexed as

humaninduction of labormisoprostolpharmacokineticspregnancy

Identifiers

PMID32116725
PMCPMC7029744
OpenAlexW3006599932

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.