Evidence map›Paper›PMID 35795714›Full record

ArticleEClinicalMedicine2022

Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial.

Hideto Yamada, Masashi Deguchi, Shigeru Saito, Toshiyuki Takeshita, Mari Mitsui, Tsuyoshi Saito, Takeshi Nagamatsu, Koichi Takakuwa, Mikiya Nakatsuka, Satoshi Yoneda and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02184741 (A Double-Blind, Randomized, Placebo-Controlled Study of GB-0998 in Patients With Unexplained Recurrent Miscarriage.), which is not on this map. Cited by 30 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 6 pooled it
4.6field-weighted citation impact, top 4% 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.

NCT02184741 phase3completednot on this map

A Double-Blind, Randomized, Placebo-Controlled Study of GB-0998 in Patients With Unexplained Recurrent Miscarriage.

TypeinterventionalSponsorJapan Blood Products OrganizationRan2014 to 2020Enrolled99ConditionsRecurrent MiscarriageArmsGB-0998, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 6 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Australasian recurrent pregnancy loss clinical management guideline 2024, part II.The Australian & New Zealand journal of obstetrics & gynaecology · 2024
    Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. ACCEPT Group Condensed Position Paper on the Management of Recurrent Pregnancy Loss.The Australian & New Zealand journal of obstetrics & gynaecology · 2025
    Article
  15. Review
  16. Review
  17. Article
  18. Article
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  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 1 country.

Hideto YamadaCentre for Recurrent Pregnancy Loss, Teine Keijinkai Hospital, 1-40 Maeda 1-jho 12-chome Teine-ku, Sapporo, Japan.
Masashi DeguchiDepartment of Obstetrics and Gynecology, Kobe University School of Medicine, 7-5-1 Kusunoki-cho Chuo-ku, Kobe, Japan.
Shigeru SaitoDepartment of Obstetrics and Gynecology, the Toyama University, 2630, Sugitani, Toyama, Japan.
Toshiyuki TakeshitaDepartment of Obstetrics and Gynecology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
Mari MitsuiDivision of Reproductive Medicine and Maternal Care, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, Japan.
Tsuyoshi SaitoDepartment of Obstetrics and Gynecology, Sapporo Medical University, Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo, Japan.
Takeshi NagamatsuDepartment of Obstetrics and Gynecology, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Koichi TakakuwaDepartment of Obstetrics and Gynecology, Niigata University, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan.
Mikiya NakatsukaOkayama University, Graduate School of Health Sciences, 2-5-1 Shikata, Kita-ku, Okayama, Japan.
Satoshi YonedaDepartment of Obstetrics and Gynecology, the Toyama University, 2630, Sugitani, Toyama, Japan.
Katsuko EgashiraDepartment of Obstetrics and Gynecology, Kyushu University Graduate School of Medicine, 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan.
Masahito TachibanaDepartment of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan.
Keiichi MatsubaraDepartment of Obstetrics and Gynecology, Ehime University School of Medicine, 454, Shitsukawa, Toon, Japan.
Ritsuo HondaDepartment of Obstetrics and Gynecology, Kumamoto University School of Medicine, 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
Atsushi FukuiDepartment of Obstetrics and Gynecology, Hirosaki University School of Medicine, 53,Honcho, Hirosaki, Japan.
Kanji TanakaDepartment of Obstetrics and Gynecology, Hirosaki University School of Medicine, 53,Honcho, Hirosaki, Japan.
Kazuo SengokuDepartment of Obstetrics and Gynecology, Asahikawa Medical University, 1-1-1 Midorigaoka-higashi 2-jo, Asahikawa, Japan.
Toshiaki EndoDepartment of Obstetrics and Gynecology, Sapporo Medical University, Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo, Japan.
Hiroaki YataResearch & Development Division, Japan Blood Products Organization, 15F Tamachi Station Tower N 3-1-1 Shibaura, Minato-ku, Tokyo, Japan.
Hirosaki University · JPSapporo Medical University · JPUniversity of Toyama · JPAsahikawa Medical University · JPEhime University · JPKobe University · JPKumamoto University · JPKyushu University · JPNational Center For Child Health and Development · JPNiigata University Medical and Dental Hospital · JPNippon Medical School · JPOkayama University · JPTeine Keijinkai Hospital · JPThe University of Tokyo · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There is no effective treatment for women with unexplained recurrent pregnancy loss (RPL). We aimed to investigate whether treatment with a high dose of intravenous immunoglobulin (IVIG) in early pregnancy can improve pregnancy outcomes in women with unexplained RPL. Methods: In a double-blind, randomised, placebo-controlled trial, women with primary RPL of unexplained aetiology received 400 mg/kg of IVIG daily or placebo for five consecutive days starting at 4-6 weeks of gestation. They had experienced four or more miscarriages except biochemical pregnancy loss and at least one miscarriage of normal chromosome karyotype. The primary outcome was ongoing pregnancy rate at 22 weeks of gestation, and the live birth rate was the secondary outcome. We analysed all women receiving the study drug (intention-to-treat, ITT) and women except those who miscarried due to fetal chromosome abnormality (modified-ITT). This study is registered with ClinicalTrials.gov number, NCT02184741. Findings: From June 3, 2014 to Jan 29, 2020, 102 women were randomly assigned to receive IVIG ( Interpretation: A high dose of IVIG in very early pregnancy improved pregnancy outcome in women with four or more RPLs of unexplained aetiology. Funding: The Japan Blood Products Organization.

Indexed as

AbortionIntravenous immunoglobulinPregnancy outcomeRecurrent miscarriageRecurrent pregnancy lossUnknown aetiology

Identifiers

PMID35795714
PMCPMC9251568
OpenAlexW4283688364

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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.