Evidence map›Paper›PMID 41225548›Full record

ArticleTrials2025

Pravastatin for the prevention of recurrent hypertensive disorders of pregnancy: study protocol for a randomized, open-label, parallel-group, three-arm trial.

Keiichi Kumasawa, Kosuke Kashiwabara, Mariko Inoue, Kayoko Kaneko, Hironobu Hyodo, Takahiro Yamashita, Takayuki Iriyama, Takeshi Nagamatsu, Mayumi Sako, Toru Kobayashi and 4 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. 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
–field-weighted citation impact
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.

  1. 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

14 authors.

Keiichi KumasawaDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan. kumasawak-gyn@h.u-tokyo.ac.jp.
Kosuke KashiwabaraClinical Research Promotion Center, The University of Tokyo, Tokyo, Japan.
Mariko InoueClinical Research Promotion Center, The University of Tokyo, Tokyo, Japan.
Kayoko KanekoDivision of Maternal Medicine, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.
Hironobu HyodoDepartment of Obstetrics and Gynecology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Takahiro YamashitaDepartment of Obstetrics and Gynecology, Aiiku Hospital, Tokyo, Japan.
Takayuki IriyamaDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan.
Takeshi NagamatsuDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan.
Mayumi SakoDepartment of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
Toru KobayashiDepartment of Data Science, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
Naoto TakahashiDepartment of Pediatrics, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Shigeru SaitoUniversity of Toyama, Toyama, Japan.
Yasushi HirotaDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan.
Yutaka OsugaDepartment of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan.

Funding

2022 Fiscal Year Japan Agency for Medical Research and Development (AMED) Grant for the Project for Babies and Infants in Research of Health and Development to Adolescents and Young Adults JP22gk0110059
6 · The paper itself

Abstract

backgroundHypertensive disorders of pregnancy lead to a critically ill maternal/fetal state due to maternal organ failure and fetal dysfunction related to placental abruption or impaired placental circulation. No treatment with established efficacy for hypertensive disorders of pregnancy is currently available, and delivery is the only definitive treatment. This article describes the study protocol for a trial that aims to evaluate whether early pravastatin treatment is effective in preventing hypertensive disorders of pregnancy.

methodsA randomized, open-label, parallel-group, three-arm trial will be conducted with aspirin administered as the baseline treatment across all groups. Pregnant women with a history of hypertensive disorders of pregnancy who are at high risk of developing hypertensive disorders of pregnancy will be recruited from four recruitment sites in Japan. The three interventions of the study comprise oral pravastatin 5 mg once daily with oral bayaspirin 100 mg once daily, oral pravastatin 10 mg once daily with oral bayaspirin 100 mg once daily, and oral bayaspirin 100 mg once daily alone. The primary outcome measure is the incidence of hypertension during pregnancy. The secondary outcome measures include incidence rates of preeclampsia and gestational hypertension, maternal serum soluble fms-like tyrosine kinase-1/placental growth factor ratio, as well as soluble fms-like tyrosine kinase-1 and placental growth factor levels, whether the mother is proteinuric, placental weight, umbilical cord blood lipid profile, the incidence of hypertensive disorders of pregnancy-related complications (placental abruption, hemolysis, elevated liver enzymes, and low platelet count syndrome, and eclampsia), week at diagnosis of hypertensive disorders of pregnancy, incidence of severe hypertensive disorders of pregnancy, and neonatal outcomes (birth weight, percentage of small for gestational age neonates, neonatal intensive care unit admission rate, and auditory brainstem response). DISCUSSION: The results of this study are expected to have wide-ranging implications given the effects of hypertensive disorders of pregnancy on long-term maternal and child health, as well as health economics.

trial registrationJapan Registry of Clinical Trials (Trial ID: jRCTs031230067; registered May 11, 2023; https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031230067 ).

Indexed as

Hydroxymethylglutaryl-CoA Reductase InhibitorsHypertension, Pregnancy-InducedPravastatinSecondary PreventionAdministration, OralAdultFemaleHumansJapanMulticenter Studies as TopicPlacenta Growth FactorPre-EclampsiaPregnancyRandomized Controlled Trials as TopicRecurrenceTreatment OutcomeFLT1 protein, humanHydroxymethylglutaryl-CoA Reductase InhibitorsPlacenta Growth FactorPravastatinVascular Endothelial Growth Factor Receptor-1EfficacyHypertensive disorders of pregnancyOutcomesPravastatinRandomized trialSafetyStudy protocol

Identifiers

PMID41225548
PMCPMC12613540

What Socratic 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 Socratic graph.