Prednisone and Aspirin in Women with Autoantibodies and Unexplained Recurrent Fetal Loss

Laskin, Carl A.; Bombardier, C.; Hannah, ME; Mandel, F. P.; Ritchie, J. W. K.; Farewell, Vernon T.; Farine, Dan; Spitzer, Karen A.; Fielding, L P; Soloninka, C A; Yeung, May T.

doi:10.1056/nejm199707173370302

Cited by 388 publications

(205 citation statements)

References 22 publications

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“…The fact that many important studies on the treatment of obstetric APS (27)(28)(29)(30)(31)(32) evoked letters to the editor (33-39) disputing their reported cutoffs in the aCL ELISA illustrates that consensus is urgently needed.…”

Section: The Obstetric Apsmentioning

confidence: 99%

“…In those women whose pregnancy and clinical histories put them in the second category (those with recurrent early fetal loss or at least 1 fetal loss, without SLE or previous thrombosis), 3 observational studies evaluated the outcome in women treated with aspirin alone (44), those who received a combination of heparin and aspirin (45), and those who declined pharmacologic treatment and received standard care (46). In 9 prospective studies (12,(29)(30)(31)(32)(47)(48)(49)(50), 2 treatment strategies were compared. All but 2 of these studies (47,50) were randomized studies.…”

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

“…All but 2 of these studies (47,50) were randomized studies. The treatments included placebo (12,29,32), aspirin alone (12,(30)(31)(32)47,49), aspirin plus prednisone (29,48,49), and heparin plus aspirin (30,31,47,48,50) (Table 3). Evaluation of pregnancies started with a positive pregnancy test (12,29,32,44,47,48,50) or the presence of fetal heart activity (30,31,45,46,49).…”

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

“…Three randomized studies included a regimen of prednisone and aspirin (29,48,49). The pregnancy outcome of women receiving this treatment was compared with that of women receiving a combination of heparin and aspirin (48), aspirin alone (49), or placebo (29). The daily dose of aspirin was 80-100 mg. Each study used a different dosage of prednisone, as follows: a standard daily dose of 40 mg throughout pregnancy, starting when pregnancy was confirmed (48); a daily dose of 20 mg starting when viability was confirmed, with dose adjustments throughout pregnancy based on results of aPL tests (daily dose 10-40 mg) (49); and a daily dose of 0.8 mg/kg of body weight (maximum 60 mg) for 4 weeks, followed by 0.5 mg/kg of body weight per day until delivery (29).…”

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

See 4 more Smart Citations

Management of the obstetric antiphospholipid syndrome

Derksen¹,

Khamashta²,

Branch³

2004

Arthritis & Rheumatism

185

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Section: The Obstetric Apsmentioning

confidence: 99%

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

Section: Treatment Of Pregnancy In Women With Aplmentioning

confidence: 99%

See 3 more Smart Citations

Management of the obstetric antiphospholipid syndrome

Derksen¹,

Khamashta²,

Branch³

2004

Arthritis & Rheumatism

185

View full text Add to dashboard Cite

Prednisone vs Placebo and Live Birth in Patients With Recurrent Implantation Failure Undergoing In Vitro Fertilization

Sun

Cui

et al. 2023

JAMA

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ImportanceImplantation failure remains a critical barrier to in vitro fertilization. Prednisone, as an immune-regulatory agent, is widely used to improve the probability of implantation and pregnancy, although the evidence for efficacy is inadequate.ObjectiveTo determine the efficacy of 10 mg of prednisone compared with placebo on live birth among women with recurrent implantation failure.Design, Setting, and ParticipantsA double-blind, placebo-controlled, randomized clinical trial conducted at 8 fertility centers in China. Eligible women who had a history of 2 or more unsuccessful embryo transfer cycles, were younger than 38 years when oocytes were retrieved, and were planning to undergo frozen-thawed embryo transfer with the availability of good-quality embryos were enrolled from November 2018 to August 2020 (final follow-up August 2021).InterventionsParticipants were randomized (1:1) to receive oral pills containing either 10 mg of prednisone (n = 357) or matching placebo (n = 358) once daily, from the day at which they started endometrial preparation for frozen-thawed embryo transfer through early pregnancy.Main Outcomes and MeasuresThe primary outcome was live birth, defined as the delivery of any number of neonates born at 28 or more weeks’ gestation with signs of life.ResultsAmong 715 women randomized (mean age, 32 years), 714 (99.9%) had data available on live birth outcomes and were included in the primary analysis. Live birth occurred among 37.8% of women (135 of 357) in the prednisone group vs 38.8% of women (139 of 358) in the placebo group (absolute difference, −1.0% [95% CI, −8.1% to 6.1%]; relative ratio [RR], 0.97 [95% CI, 0.81 to 1.17]; P = .78). The rates of biochemical pregnancy loss were 17.3% in the prednisone group and 9.9% in the placebo group (absolute difference, 7.5% [95% CI, 0.6% to 14.3%]; RR, 1.75 [95% CI, 1.03 to 2.99]; P = .04). Of those in the prednisone group, preterm delivery occurred among 11.8% and of those in the placebo group, 5.5% of pregnancies (absolute difference, 6.3% [95% CI, 0.2% to 12.4%]; RR, 2.14 [95% CI, 1.00 to 4.58]; P = .04). There were no statistically significant between-group differences in the rates of biochemical pregnancy, clinical pregnancy, implantation, neonatal complications, congenital anomalies, other adverse events, or mean birthweights.Conclusions and RelevanceAmong patients with recurrent implantation failure, treatment with prednisone did not improve live birth rate compared with placebo. Data suggested that the use of prednisone may increase the risk of preterm delivery and biochemical pregnancy loss. Our results challenge the value of prednisone use in clinical practice for the treatment of recurrent implantation failure.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR1800018783

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