Evidence map›Paper›PMID 34170943›Full record

Trial reportPloS one2021

Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study).

Pim B B Schol, Natascha M de Lange, Mallory D Woiski, Josje Langenveld, Luc J M Smits, Martine M Wassen, Yvonne M Henskens, Hubertina C J Scheepers

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
4.7field-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.

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

4 citing papers in PubMed, 16 citations in OpenAlex.

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

8 authors at 3 institutions in 1 country.

Pim B B ScholDepartment of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0002-6486-4508
Natascha M de LangeDepartment of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Mallory D WoiskiDepartment of Obstetrics and Gynecology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Josje LangenveldDepartment of Obstetrics and Gynecology, Zuyderland, Sittard-Geleen, The Netherlands.
Luc J M SmitsDepartment of Epidemiology, Caphri School for Public Health and Primary Care, Maastricht, The Netherlands.
Martine M WassenDepartment of Obstetrics and Gynecology, Zuyderland, Sittard-Geleen, The Netherlands.
Yvonne M HenskensCentral Diagnostics Laboratory, Maastricht University Medical Centre, Maastricht, The Netherlands.
Hubertina C J ScheepersDepartment of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Maastricht University Medical Centre · NLZuyderland Medisch Centrum · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy.

objectiveWe hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH. STUDY

designIn four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle.

resultsFrom August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups.

conclusionsAlthough a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation.

trial registrationNTR3789.

Indexed as

Blood TransfusionFluid TherapyHemostaticsResuscitationAdultFemaleHumansMiddle AgedPostpartum HemorrhageHemostatics

Identifiers

PMID34170943
PMCPMC8232446
OpenAlexW3175584485

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.