IV immunoglobulin may improve pregnancy outcomes in women with recurrent pregnancy loss: Lancet

Japan: A high intravenous immunoglobulin (IVIG) dosage given early in pregnancy improved pregnancy outcomes in women with four or more recurrent pregnancy losses (RPLs) of unknown cause, says an article published in The Lancet.

There is no effective therapy available for women who have unexplained recurrent pregnancy loss. As a result, Hideto Yamada and colleagues undertook this trial to see if treating women with unexplained RPL with a high dosage of intravenous immunoglobulin in early pregnancy might enhance pregnancy outcomes.

Women with primary RPL of unknown cause received 400 mg/kg IVIG daily or placebo for five consecutive days beginning at 4-6 weeks of gestation in a randomized, double-blind, placebo-controlled experiment. Except for biochemical pregnancy loss and at least one miscarriage of normal chromosomal karyotype, they had four or more losses. The primary objective was the continued pregnancy rate at 22 weeks of gestation, while the secondary outcome was the live birth rate. All women who received the trial treatment (intention-to-treat, ITT) and all women who miscarried owing to fetal chromosomal abnormalities (modified-ITT) were extensively examined.

The key findings of this study were as follows:

1. From June 3, 2014, to January 29, 2020, 102 women were allocated at random to either IVIG (n = 53) or placebo (n = 49).

2. Because three women were excluded, 50 women in the ITT group got IVIG and 49 women received a placebo.

3. In the ITT population, the IVIG group had a greater rate of continued pregnancy at 22 weeks of gestation and a higher rate of live birth than the placebo group.

4. The continued pregnancy rate and the live birth rate rose considerably in women who got IVIG at 4-5 weeks of gestation compared to placebo, but similar gains were not seen in those who received IVIG at 6 weeks of gestation.

5. Congenital abnormalities were found in four babies in the IVIG group and none in the placebo group.

In conclusion, a high IVIG dosage in very early pregnancy enhanced pregnancy outcomes in women with 4 RPLs of unknown cause. This breakthrough therapy will provide women with severe unexplainable RPL with the hope of having a healthy child.

Reference:

Yamada, H., Deguchi, M., Saito, S., Takeshita, T., Mitsui, M., Saito, T., Nagamatsu, T., Takakuwa, K., Nakatsuka, M., Yoneda, S., Egashira, K., Tachibana, M., Matsubara, K., & Yata, H. (2022). Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial. In eClinicalMedicine (Vol. 50, p. 101527). Elsevier BV. https://doi.org/10.1016/j.eclinm.2022.101527