Evidence map›Paper›PMID 33681738›Full record

ArticleEClinicalMedicine2021

Mifepristone followed by misoprostol compared with placebo followed by misoprostol as medical treatment for early pregnancy loss (the Triple M trial): A double-blind placebo-controlled randomised trial.

Charlotte Hamel, Sjors Coppus, Joyce van den Berg, Esther Hink, Jacoba van Seeters, Paul van Kesteren, Ashley Merién, Bas Torrenga, Rafli van de Laar, Josien Terwisscha van Scheltinga and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03212352 (Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT03212352 phase4terminatednot on this map

Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)

TypeinterventionalSponsorRadboud University Medical CenterRan2018 to 2020Enrolled342ConditionsEarly Pregnancy FailureArmsMifepristone, Misoprostol
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Methods for managing miscarriage: a network meta-analysis.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Ectopic pregnancy.Nature reviews. Disease primers · 2024
    Review
  5. Article
  6. Article
  7. Article
  8. Retained Products of Conception (RPOC): Diagnosis, Complication & Management.Journal of obstetrics and gynaecology of India · 2023
    Review
  9. Article
  10. Article
  11. Surgical intervention after medical treatment for early pregnancy loss according to gestational size.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2023
    Article
  12. Article
  13. Article
  14. Diagnostic criteria for retained products of conception-A scoping review.Acta obstetricia et gynecologica Scandinavica · 2021
    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

16 authors at 12 institutions in 2 countries.

Charlotte HamelDepartment of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.
Sjors CoppusDepartment of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands.
Joyce van den BergDepartment of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, the Netherlands.
Esther HinkDepartment of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands.
Jacoba van SeetersDepartment of Obstetrics and Gynaecology, Amphia Hospital, Breda, the Netherlands.
Paul van KesterenDepartment of Obstetrics and Gynaecology, OLVG, the Netherlands.
Ashley MeriénDepartment of Obstetrics and Gynaecology, Rijnstate, Arnhem, the Netherlands.
Bas TorrengaDepartment of Obstetrics and Gynaecology, Ikazia Hospital, the Netherlands.
Rafli van de LaarDepartment of Obstetrics and Gynaecology, Vie Curi Medical Centre, the Netherlands.
Josien Terwisscha van ScheltingaDepartment of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands.
Ingrid Gaugler-SendenDepartment of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Peppino GraziosiDepartment of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Minouche van RumsteDepartment of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, the Netherlands.
Ewka NelissenDepartment of Obstetrics and Gynaecology, Laurentius Hospital, Roermond, the Netherlands.
Frank VandenbusscheDepartment of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands.
Marcus SnijdersDepartment of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.
Radboud University Nijmegen · NLAmphia Ziekenhuis · NLCanisius-Wilhelmina Ziekenhuis · NLIkazia Ziekenhuis · NLJeroen Bosch Ziekenhuis · NLLaurentius Ziekenhuis · NLMaasstad Ziekenhuis · NLOLVG · NLRijnstate Hospital · NLSt. Antonius Ziekenhuis · NLVieCuri Medisch Centrum · NLZiekenhuis Gelderse Vallei · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWorldwide, millions of women seek treatment for early pregnancy loss (EPL) annually. Medical management with misoprostol is widely used, but only effective 60% of the time. Pre-treatment with mifepristone prior to misoprostol might improve the success rate of medical management.

methodsThis was a multi-centre, double-blind, placebo-controlled randomised trial in 17 Dutch hospitals. Women with a non-viable pregnancy between 6 and 14 weeks of gestation were eligible for inclusion after at least one week of expectant management. Participants were randomised (1:1) between oral mifepristone 600 mg or an oral placebo tablet. Participants took 400 μg misoprostol orally, repeated after four hours on day two and, if necessary, day three. Primary outcome was expulsion of gestational sac and endometrial thickness <15 mm after 6-8 weeks. Analyses were done according to intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT03212352.

findingsBetween June 28th 2018 and January 8th 2020, 175 women were randomised to mifepristone and 176 to placebo, including 344 in the intention-to-treat analysis. In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group (

interpretationPre-treatment with mifepristone prior to misoprostol was more effective than misoprostol alone in managing EPL.

fundingHealthcare Insurers Innovation Foundation, Radboud University Medical Centre, Canisius Wilhelmina Hospital.

Indexed as

Early pregnancy lossMifepristoneMisoprostol

Identifiers

PMID33681738
PMCPMC7910666
OpenAlexW3119713954

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.