Evidence map›Paper›PMID 41789451›Full record

Trial reportHypertension (Dallas, Tex. : 1979)2026

Randomized Study of Antithrombin in Early-Onset Preeclampsia: KOUNO-TORI Study.

Jun Takeda, Daisuke Tachibana, Atsuo Itakura, Kenichi Takagi, Shoichi Nakami, Hirotaka Mano, Takao Kobayashi, Naohiro Kanayama, Hiroshi Sameshima, Mamoru Morikawa and 8 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hypertension (Dallas, Tex. : 1979), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04182373 (A Phase 3, Randomized, Placebo-controlled, Double Blind Study of KW-3357 in Patients With Early Onset Severe Preeclampsia), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04182373 phase3completednot on this map

A Phase 3, Randomized, Placebo-controlled, Double Blind Study of KW-3357 in Patients With Early Onset Severe Preeclampsia

TypeinterventionalSponsorKyowa Kirin Co., Ltd.Ran2019 to 2023Enrolled181ConditionsPreeclampsiaArmsAntithrombin gamma, physiological saline
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

Jun TakedaDepartment of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Bunkyo-ku, Japan (J.T., A.I., S.T.).ORCID 0000-0002-6195-8971
Daisuke TachibanaDepartment of Obstetrics and Gynecology, Osaka Metropolitan University Graduate School of Medicine, Japan (D.T.).ORCID 0009-0009-8029-5921
Atsuo ItakuraDepartment of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Bunkyo-ku, Japan (J.T., A.I., S.T.).ORCID 0000-0002-4554-164X
Kenichi TakagiClinical Science Department, Development Division (K.T.), Kyowa Kirin Co., Ltd., Chiyoda-ku, Japan.
Shoichi NakamiClinical Development Center, Development Division (S.N.), Kyowa Kirin Co., Ltd., Chiyoda-ku, Japan.
Hirotaka ManoBiostatistical Science Group, Biometrics Department, Development Division (H.M.), Kyowa Kirin Co., Ltd., Chiyoda-ku, Japan.
Takao KobayashiDepartment of Obstetrics and Gynecology, Hamamatsu Medical Center, Japan (T.K.).
Naohiro KanayamaShizuoka College of Medicalcare Science, Hamamatsu, Japan (N.K.).
Hiroshi SameshimaUniversity of Miyazaki, Japan (H.S.).ORCID 0000-0001-8898-4857
Mamoru MorikawaDepartment of Obstetrics and Gynecology, Kansai Medical University, Hirakata, Japan (M.M.).
Haruhiko SagoSanno Birth Center, Minato-ku, Japan (H.S.).ORCID 0000-0001-9387-1849
Tomoko AdachiImperial Gift Foundation, Aiiku Maternal and Child Health Center, Aiiku Hospital, Minato-ku, Japan (T.A.).
Akihide OhkuchiDepartment of Obstetrics and Gynecology, Jichi Medical University, Shimotsuke, Japan (A.O.).ORCID 0000-0002-8861-1572
Satoru TakedaDepartment of Obstetrics and Gynecology, Juntendo University Faculty of Medicine, Bunkyo-ku, Japan (J.T., A.I., S.T.).ORCID 0000-0001-9547-1435
Hisashi MasuyamaDepartment of Obstetrics and Gynecology, Okayama University Hospital, Kita-ku, Japan (H.M.).
Hiroyuki SekiSaitama Medical Center, Saitama Medical University, Kawagoe, Japan (H.S.).
Shigeru SaitoUniversity of Toyama, Japan (S.S.).ORCID 0000-0002-8940-3708
KOUNO-TORI Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn preeclampsia, prolonging pregnancy decreases the risks of fetal morbidity and death. This study aimed to evaluate the efficacy and safety of antithrombin in prolonging pregnancy early-onset severe preeclampsia.

methodsThis was a randomized, double-blind, placebo-controlled study involving women with early-onset preeclampsia from 61 institutions. Participants developed early-onset severe preeclampsia from 24+0 to 31+6 weeks' gestation and had ≤100% antithrombin activity. Two groups were created, with random and blinded assignment of the participants 1:1 to a placebo (saline) group (n=92) or a recombinant human antithrombin-gamma (rhAT-gamma) group (n=90). The number of days from treatment initiation to delivery was recorded in each group, as the primary end point.

resultsPregnancy was prolonged by 13 days (95% CI, 10.4-15.6) in the placebo group and 16.9 days (95% CI, 13.8-20.0) in the rhAT-gamma group (

conclusionsNo significant difference in pregnancy prolongation was found between the placebo and rhAT-gamma participants with early-onset severe preeclampsia. However, compared with the placebo group, the rhAT-gamma group appeared to have higher rates of hemorrhage-related adverse events and anemia. REGISTRATION: URL: https://jrct.niph.go.jp/en-top; Unique identifier: jRCT2080224912. URL: https://clinicaltrials.gov/; Unique identifier: NCT04182373.

Indexed as

AntithrombinsPre-EclampsiaAdultDouble-Blind MethodFemaleGestational AgeHumansPregnancyTreatment OutcomeAntithrombinsantithrombinsclinical trialhemorrhagepre-eclampsiapregnancy

Identifiers

PMID41789451
PMCPMC13189381

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.