Evidence map›Paper›PMID 31075246›Full record

Trial reportAmerican journal of obstetrics and gynecology2019

A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.

David M Haas, Joanne Daggy, Kathleen M Flannery, Meredith L Dorr, Carrie Bonsack, Surya S Bhamidipalli, Rebecca C Pierson, Anthony Lathrop, Rachel Towns, Nicole Ngo and 3 more

Abstract readComparative StudyEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Low-dose oral misoprostol for induction of labour.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Article
  4. Methods of induction of labour: a network meta-analysis.The Cochrane database of systematic reviews · 2026
    Article
  5. Misoprostol use in obstetrics.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023
    Article
  6. Review
  7. Article
  8. Review of Evidence-Based Methods for Successful Labor Induction.Journal of midwifery & women's health · 2021
    Review
  9. 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

13 authors.

David M HaasDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana; Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: dahaas@iupui.edu.
Joanne DaggyDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.
Kathleen M FlanneryDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana.
Meredith L DorrHealthNet, Indianapolis, Indiana.
Carrie BonsackHealthNet, Indianapolis, Indiana.
Surya S BhamidipalliDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.
Rebecca C PiersonDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana; Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana.
Anthony LathropHealthNet, Indianapolis, Indiana.
Rachel TownsDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana.
Nicole NgoInvestigational Pharmacy, Eskenazi Health, Indianapolis, Indiana.
Annette HeadInvestigational Pharmacy, IU Health, Indianapolis, Indiana.
Sarah MorganHealthNet, Indianapolis, Indiana.
Sara K QuinneyDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana; Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana.

Funding

Indiana University Comprehensive Training in Clinical PharmacologyT32GM008425 · NIGMS · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI Zeruesenay Desta, Michael Thomas Eadon · 1992 to 2026
$7.7M
Pharmacokinetics and modeling of betamethasone therapy in threatened preterm birthR01HD088014 · NICHD · INDIANA UNIVERSITY INDIANAPOLIS · PI HAAS, DAVID M. · 2016 to 2020
$2.6M
NICHD NIH HHS R01 HD088014NIGMS NIH HHS T32 GM008425
6 · The paper itself

Abstract

backgroundCervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route.

objectiveTo compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term. STUDY

designThe IMPROVE trial was an institutional review board-approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) and a matching placebo tablet by the opposite route. The primary outcomes were time to delivery and the rate of cesarean delivery performed urgently for fetal nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis.

resultsThe trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, P

conclusionWe were unable to demonstrate noninferiority. In leading to a higher rate of vaginal deliveries, more rapid vaginal delivery, and fewer cesareans for fetal issues, vaginal misoprostol may be superior to buccal misoprostol for cervical ripening at term.

Indexed as

Cervical RipeningAdministration, BuccalAdministration, IntravaginalAdolescentAdultCesarean SectionDouble-Blind MethodFemaleFollow-Up StudiesHumansLabor, InducedMisoprostolOutcome Assessment, Health CareOxytocicsPregnancyTime FactorsMisoprostolOxytocicsBuccalcervical ripeninglabor inductionmisoprostolterm pregnancyvaginal

Identifiers

PMID31075246
PMCPMC7692024

What OpenQuestion holds

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Registered trials

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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.