Evidence map›Paper›PMID 35650569›Full record

ArticleBMC pregnancy and childbirth2022

Facilitating safety evaluation in maternal immunization trials: a retrospective cohort study to assess pregnancy outcomes and events of interest in low-risk pregnancies in England.

Megan Riley, Dimitra Lambrelli, Sophie Graham, Ouzama Henry, Andrea Sutherland, Alexander Schmidt, Nicola Sawalhi-Leckenby, Robert Donaldson, Sonia K Stoszek

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 23% 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, 7 citations in OpenAlex.

  1. 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

9 authors at 2 institutions in 1 country.

Megan RileyGSK, 14200 Shady Grove Rd, Rockville, MD, 20850, Washington, USA. megan.x.riley@gsk.com.
Dimitra LambrelliEvidera, 201 Talgarth Rd, Hammersmith, London, W6 8BJ, UK.
Sophie GrahamEvidera, 201 Talgarth Rd, Hammersmith, London, W6 8BJ, UK.
Ouzama HenryGSK, 14200 Shady Grove Rd, Rockville, MD, 20850, Washington, USA.
Andrea SutherlandGSK, 14200 Shady Grove Rd, Rockville, MD, 20850, Washington, USA.
Alexander SchmidtGSK, 14200 Shady Grove Rd, Rockville, MD, 20850, Washington, USA.
Nicola Sawalhi-LeckenbyEvidera, 201 Talgarth Rd, Hammersmith, London, W6 8BJ, UK.
Robert DonaldsonEvidera, 201 Talgarth Rd, Hammersmith, London, W6 8BJ, UK.
Sonia K StoszekGSK, 14200 Shady Grove Rd, Rockville, MD, 20850, Washington, USA.
Universities at Shady Grove · USModerna Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMaternal characteristics like medical history and health-related risk factors can influence the incidence of pregnancy outcomes and pregnancy-related events of interest (EIs). Data on the incidence of these endpoints in low-risk pregnant women are needed for appropriate external safety comparisons in maternal immunization trials. To address this need, this study estimated the incidence proportions of pregnancy outcomes and pregnancy-related EIs in different pregnancy cohorts (including low-risk pregnancies) in England, contained in the Clinical Practice Research Datalink (CPRD) Pregnancy Register linked to Hospital Episode Statistics (HES) between 2005 and 2017.

methodsThe incidence proportions of 7 pregnancy outcomes and 15 EIs were calculated for: (1) all pregnancies (AP) represented in the CPRD Pregnancy Register linked to HES (AP cohort; N = 298 155), (2) all pregnancies with a gestational age (GA) ≥ 24 weeks (AP24+ cohort; N = 208 328), and (3) low-risk pregnancies (LR cohort; N = 137 932) with a GA ≥ 24 weeks and no diagnosis of predefined high-risk medical conditions until 24 weeks GA.

resultsMiscarriage was the most common adverse pregnancy outcome in the AP cohort (1 379.5 per 10 000 pregnancies) but could not be assessed in the other cohorts because these only included pregnancies with a GA ≥ 24 weeks, and miscarriages with GA ≥ 24 weeks were reclassified as stillbirths. Preterm delivery (< 37 weeks GA) was the most common adverse pregnancy outcome in the AP24+ and LR cohorts (742.9 and 680.0 per 10 000 pregnancies, respectively). Focusing on the cohorts with a GA ≥ 24 weeks, the most common pregnancy-related EIs in the AP24+ and LR cohorts were fetal/perinatal distress or asphyxia (1 824.3 and 1 833.0 per 10 000 pregnancies), vaginal/intrauterine hemorrhage (799.2 and 729.0 per 10 000 pregnancies), and labor protraction/arrest disorders (752.4 and 774.5 per 10 000 pregnancies).

conclusionsThis study generated incidence proportions of pregnancy outcomes and pregnancy-related EIs from the CPRD for different pregnancy cohorts, including low-risk pregnancies. The reported incidence proportions of pregnancy outcomes and pregnancy-related EIs are largely consistent with external estimates. These results may facilitate the interpretation of safety data from maternal immunization trials and the safety monitoring of maternal vaccines. They may also be of interest for any intervention studied in populations of pregnant women.

Indexed as

Abortion, SpontaneousPregnancy OutcomeEnglandFemaleHumansInfantInfant, NewbornPregnancyRetrospective StudiesUterine HemorrhageVaccinationBackground rateLow-risk pregnancyMaternal immunization trialMaternal vaccinationMiscarriagePharmacovigilancePregnancy outcomesPregnancy-related events of interestPreterm delivery

Identifiers

PMID35650569
PMCPMC9157029
OpenAlexW4281677959

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.