Evidence map›Paper›PMID 29566729›Full record

ArticleTrials2018

Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2).

Lauren M Bullens, Alexandra D J Hulsenboom, Suzanne Moors, Rohan Joshi, Pieter J van Runnard Heimel, M Beatrijs van der Hout-van der Jagt, Edwin R van den Heuvel, S Guid Oei

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.1field-weighted citation impact, top 22% 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

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Lauren M BullensDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands. laurenbullens@gmail.com.ORCID http://orcid.org/0000-0003-0520-657X
Alexandra D J HulsenboomDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Suzanne MoorsDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Rohan JoshiDepartment of Clinical Physics, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Pieter J van Runnard HeimelDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
M Beatrijs van der Hout-van der JagtDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Edwin R van den HeuvelDepartment of Mathematics and Computer Science, Eindhoven University of Technology, PO Box 513, 5600, MB, Eindhoven, The Netherlands.
S Guid OeiDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
Radboud University Nijmegen · NLEindhoven University of Technology · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPerinatal asphyxia is, even in developed countries, one the major causes of neonatal morbidity and mortality. Therefore, if foetal distress during labour is suspected, one should try to restore foetal oxygen levels or aim for immediate delivery. However, studies on the effect of intrauterine resuscitation during labour are scarce. We designed a randomised controlled trial to investigate the effect of maternal hyperoxygenation on the foetal condition. In this study, maternal hyperoxygenation is induced for the treatment of foetal distress during the second stage of term labour. METHODS/

designThis study is a single-centre randomised controlled trial being performed in a tertiary hospital in The Netherlands. From among cases of a suboptimal or abnormal foetal heart rate pattern during the second stage of term labour, a total of 116 patients will be randomised to the control group, where normal care is provided, or to the intervention group, where before normal care 100% oxygen is supplied to the mother by a non-rebreathing mask until delivery. The primary outcome is change in foetal heart rate pattern. Secondary outcomes are Apgar score, mode of delivery, admission to the neonatal intensive care unit and maternal side effects. In addition, blood gas values and malondialdehyde are determined in umbilical cord blood. DISCUSSION: This study will be the first randomised controlled trial to investigate the effect of maternal hyperoxygenation for foetal distress during labour. This intervention should be recommended only as a treatment for intrapartum foetal distress, when improvement of the foetal condition is likely and outweighs maternal and neonatal side effects.

trial registrationEudraCT, 2015-001654-15; registered on 3 April 2015. Dutch Trial Register, NTR5461; registered on 20 October 2015.

Indexed as

Labor Stage, SecondOxygen Inhalation TherapyRandomized Controlled Trials as TopicResuscitationData Interpretation, StatisticalFemaleFetal DistressHeart Rate, FetalHumansOutcome Assessment, Health CareOxygenPregnancySample SizeOxygenCardiotocogramFoetal distressFoetal heart rateFree oxygen radicalsIntrauterine resuscitationMaternal hyperoxygenationNeonatal outcomeRandomised controlled trial

Identifiers

PMID29566729
PMCPMC5865381
OpenAlexW2794196203

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.