Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study

JRCT ID: jRCTs031180116

Registered date:12/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: anti-phospholipid antibody syndrome
• Date of first enrollment: 22/08/2015
• Target sample size: 8
• Study type: Interventional

Intervention(s)

Intravenous immunoglobulin administration (IVIG) during early pregnancy, in addition to standard anticoagulation therapy.
A five-day course of IVIG (400 mg/kg body weight) was initiated soon after confirmation of a fetal heartbeat.

Outcome(s)

• Primary Outcome: Live birth rate after 30 weeks of gestation

Secondary Outcome

1 Comparison of pregnancy outcomes (including birth outcomes) between previous pregnancies and the current pregnancy with the intervention (efficacy)
2 Assessment of the prevalence of pregnancy complications (gestational hypertension, preeclampsia, HELLP syndrome, placental abruption, and fetal growth restriction [FGR]) (efficacy)
3 Changes in antiphospholipid antibody titers (aCL IgG/IgM, aCL&beta2GP-I IgG, LA) (efficacy)
4 All adverse events, including laboratory test results during pregnancy and the postpartum period (safety)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 50age old
• Gender: Female

Include criteria

Pregnant women with APS diagnosed according to the international criteria who meet the following inclusion criteria will be enrolled:
1.One or more unexplained episodes of fetal death of a morphologically normal fetus at or beyond the 10th week of gestation, an episode of fetal death without fetal chromosomal abnormalities at or beyond the 10th week of gestation, or an episode of preterm delivery before the 30th week of gestation due to pregnancy complications (e.g., severe preeclampsia or gestational hypertension, FGR, or placental abruption) despite standard anticoagulation therapy.
2.A history of vascular thrombosis due to pregnancy despite standard anticoagulation therapy.

Exclude criteria

1 History of drug hypersensitivity
2 History of heparin-induced thrombocytopenia
3 Hereditary fructose intolerance
4 IgA deficiency
5 Uterine anomalies, uterine submucosal myomas, or intrauterine tumors more than 10 cm in diameter
6 Inability to obtain written informed consent
7 Abnormal laboratory blood test results:
Platelets are less than 50000/mm3
ALT, ALT, LDH, and ganma-GTP are more than 1.5 times the upper limit at each institution
Plasma creatinine is more than 0.8 mg/dl

Related Information

• Primary Sponsor: Murashima Atsuko
• Source(s) of Monetary Support: Japan Blood Products Organization,Japan Blood Products Organization