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For those with unexplained pregnancy loss, these results could prove promising improvements to birth outcomes.
In a real-world study, intravenous immunoglobulin (IVIG) was found to significantly improve live birth rates (LBRs) in patients with unexplained recurrent pregnancy loss (uRPL) compared to control patients, according to trial data published in the Journal of Reproductive Immunology.1
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According to a report from Green and O’Donoghue, the definition of uRPL can vary. The American Society for Reproductive Medicine and other associations define it as 2 miscarriages, whereas the Royal College of Obstetricians and Gynecologists defines it as 3 consecutive pregnancy loses.2
Generally, it is considered a spontaneous loss of 2 or more pregnancies that occur prior to the 24th gestational week. Although there are some factors that can cause the condition, most cases of RPL remain poorly understood, presenting further challenges and burden for patients.1
IVIG has previously shown promise in improving live birth outcomes in RPL populations but has also proven controversial; some randomized trials and meta-analyses have shown inconsistent results regarding the role of IVIG in improving pregnancy outcomes. However, various factors among these trials, including differences in RPL definitions, inclusion criteria, and sample sizes make this evidence unreliable.1
1. Intravenous immunoglobulin was effective in increasing live birth rates in patients with unexplained recurrent pregnancy loss (uRPL) compared to control.
2. IVIG was found to be safe in patients with uRPL.
3. These results show promise for those with uRPL seeking a safe and effective method to better their birth outcomes.
The investigators aimed to analyze the efficacy of IVIG treatment on live birth outcomes in a uRPL population, and to retrospectively review 2-year IVIG outcomes from their clinic while comparing this data to that of expected outcomes without treatment.1
Overall, 238 patients with uRPL were enrolled in the study, with 184 patients assigned to the IVIG treatment group and 54 patients assigned to the control group. Of note, the utilization of concomitant medication during pregnancy was significantly higher in the IVIG treatment group.1
After 24 weeks of gestation, the LBR in the IVIG treatment group was observed to have an approximate 20% increase compared to the control group (77.7% vs 53.7%, P = .001). Furthermore, patients with uRPL that received IVIG treatment had a later gestational week at the time of pregnancy loss (7.55 ± 1.51 vs 6.71 ± 1.40, P = .028).1
Safety outcomes for those receiving IVIG treatment were generally positive. Aside from a lower incidence of decreased platelet count in the IVIG treatment group (1.6% vs 7.4%, P = .049), there were no statistically significant differences found in white blood cell count or neutrophil count between the groups.1
A multivariable logistic regression analysis was used to correct for confounding factors in determining the association between IVIG and LBR. There was a significant association found between treatment with IVIG and increased LBR in patients with uRPL, after adjusting for age, body mass index, and previous pregnancy loses (OR = 3.012; 95% CI, 1.578-5.748).1
Subgroup analyses revealed intriguing points of data, including the fact that IVIG significantly improved the LBR in patients who previously experienced 3 or more pregnancy loses. Additionally, there were no associations found between IVIG medication regimen or the gestational week of the first medication and the LBR in patients following IVIG treatment.1
This revelation suggests that there “may be some flexibility” in the timing of IVIG treatment during early pregnancy, according to the study investigators. They noted that further work can improve the accuracy of the findings by increasing the study sample size and ensuring a balanced sample of patients for each subgroup.1
Green and O’Donoghue’s analysis ultimately found that “supportive care and selective medical management” can help achieve better outcomes among pregnant patients in clinics. Data from the current study reaffirm that point, demonstrating that IVIG can have an impactful role in improving birth outcomes within this population.1,2
“Certainly, to fully utilize the therapeutic potential of IVIG, further research is necessary to explore its efficacy, safety, and affordability in different uRPL populations,” the investigators wrote. “This will help to apply IVIG more effectively in future clinical practice and provide more optimized treatment options for uRPL patients.”1
