Evidence map›Paper›PMID 28870155›Full record

Trial reportBMC pregnancy and childbirth2017

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

Maud D van Zijl, Bouchra Koullali, Christiana A Naaktgeboren, Ewoud Schuit, Dick J Bekedam, Etelka Moll, Martijn A Oudijk, Wilhelmina M van Baal, Marjon A de Boer, Henricus Visser and 21 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Cervical pessary for preventing preterm birth in singleton pregnancies.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

31 authors at 20 institutions in 2 countries.

Maud D van ZijlDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. m.d.vanzijl@amc.nl.
Bouchra KoullaliDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Christiana A NaaktgeborenDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Ewoud SchuitJulius Centre for General Practice and Health Sciences, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands.
Dick J BekedamDepartment of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) Oost, Amsterdam, The Netherlands.
Etelka MollDepartment of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) West, Amsterdam, The Netherlands.
Martijn A OudijkDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Wilhelmina M van BaalDepartment of Obstetrics and Gynaecology, Flevoziekenhuis, Almere, The Netherlands.
Marjon A de BoerDepartment of Obstetrics and Gynaecology, VU Medical Centre (VUmc), Amsterdam, The Netherlands.
Henricus VisserDepartment of Obstetrics and Gynaecology, Tergooi Hospital, Hilversum, The Netherlands.
Joris van DrongelenDepartment of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.
Flip W van de MadeDepartment of Obstetrics and Gynaecology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands.
Karlijn C VollebregtDepartment of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands.
Moira A MullerDepartment of Obstetrics and Gynaecology, Spaarne Gasthuis, Hoofddorp, The Netherlands.
Mireille N BekkerDepartment of Obstetrics and Gynaecology, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands.
Jozien T J BronsDepartment of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, The Netherlands.
Marieke SuetersDepartment of Obstetrics and Gynaecology, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.
Josje LangenveldDepartment of Obstetrics and Gynaecology, Zuyderland Hospital, Heerlen, The Netherlands.
Maureen T FranssenDepartment of Obstetrics and Gynaecology, University Medical Centre Groningen (UMCG), Groningen, The Netherlands.
Nico W SchuitemakerDepartment of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands.
Erik van BeekDepartment of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, The Netherlands.
Hubertina C J ScheepersDepartment of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
Karin de BoerDepartment of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands.
Eveline M TepeDepartment of Obstetrics and Gynaecology, Slingeland Hospital, Doetinchem, The Netherlands.
Anjoke J M HuisjesDepartment of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, The Netherlands.
Angelo B HookerDepartment of Obstetrics and Gynaecology, Zaans Medical Centre (ZMC), Zaandam, The Netherlands.
Evelyn C J VerheijenDepartment of Obstetrics and Gynaecology, Maasziekenhuis Pantein, Boxmeer, The Netherlands.
Dimitri N PapatsonisDepartment of Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands.
Ben Willem J MolRobinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
Brenda M KazemierDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Eva PajkrtDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Academic Medical Center · NLOLVG · NLUniversity Medical Center Utrecht · NLAmphia Ziekenhuis · NLAmsterdam UMC Location VUmc · NLDiakonessenhuis hospital · NLFlevoziekenhuis · NLGelre Hospitals · NLLeiden University Medical Center · NLMaaslandziekenhuis · NLMaastricht University Medical Centre · NLMedisch Spectrum Twente · NLRadboud University Medical Center · NLRijnstate Hospital · NLSint Franciscus Gasthuis · NLSlingeland Ziekenhuis · NLSpaarne Gasthuis · NLSpaarne Ziekenhuis · NLSt. Antonius Ziekenhuis · NLTergooi · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. METHODS/

designThe Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. DISCUSSION: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples.

trial registrationTrial registration number: NTR 4414 . Date of registration January 29th 2014.

Indexed as

PessariesAdministration, IntravaginalAdolescentAdultCervical Length MeasurementCervix UteriClinical ProtocolsFemaleHumansPregnancyPregnancy OutcomePremature BirthProgesteroneProgestinsTreatment OutcomeUterine Cervical DiseasesProgesteroneProgestinsMultiplesPessaryPreterm birthPreventionProgesteroneSingletons

Identifiers

PMID28870155
PMCPMC5584011
OpenAlexW2750897569

What OpenQuestion holds

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LicenceCC BY
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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.