1. Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial
- Author
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Hideto Yamada, Masashi Deguchi, Shigeru Saito, Toshiyuki Takeshita, Mari Mitsui, Tsuyoshi Saito, Takeshi Nagamatsu, Koichi Takakuwa, Mikiya Nakatsuka, Satoshi Yoneda, Katsuko Egashira, Masahito Tachibana, Keiichi Matsubara, Ritsuo Honda, Atsushi Fukui, Kanji Tanaka, Kazuo Sengoku, Toshiaki Endo, and Hiroaki Yata
- Subjects
Abortion ,Intravenous immunoglobulin ,Pregnancy outcome ,Recurrent miscarriage ,Recurrent pregnancy loss ,Unknown aetiology ,Medicine (General) ,R5-920 - Abstract
Summary: 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 (n = 53) or placebo (n = 49). Three women were excluded; therefore 50 women received IVIG and 49 women received placebo in the ITT population. The ongoing pregnancy rate at 22 weeks of gestation (31/50 [62·0%] vs. 17/49 [34·7%]; odds ratio [OR] 3·07, 95% CI 1·35–6·97; p = 0·009) and the live birth rate (29/50 [58·0%] vs. 17/49 [34·7%]; OR 2·60, 95% CI 1·15–5·86; p = 0·03) in the IVIG group were higher than those in the placebo group in the ITT population. The ongoing pregnancy rate at 22 weeks of gestation (OR 6·27, 95% CI 2·21–17·78; p
- Published
- 2022
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