UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013496
Receipt No. R000015764
Scientific Title Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study
Date of disclosure of the study information 2014/03/25
Last modified on 2018/10/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study
Acronym Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study
Scientific Title Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study
Scientific Title:Acronym Effect of intravenous immunoglobulin (IVIG) in pregnant women with refractory obstetric antiphospholipid syndrome: A prospective single-arm interventional study
Region
Japan

Condition
Condition antiphospholipid syndrome
Classification by specialty
Clinical immunology Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Obstetric antiphospholipid syndrome (APS) is characterized by recurrent early miscarriages, fetal loss in later pregnancy, and maternal thrombosis. Although the first-line treatment regimen for women with obstetric APS is anticoagulation therapy consisting of a combination of heparin and low dose aspirin (LDA), 20-30% of cases result in pregnancy failure despite appropriate treatment. In addition, these patients are at a significantly higher risk of developing recurrent severe gestational complications such as maternal thrombosis, preeclampsia, and the HELLP syndrome.
Adding immunosuppressive therapies to standard antithrombotic therapy for refractory APS patients has been anticipated. IVIg may be a good candidate treatment for refractory obstetric APS; several reports have described the efficacy of IVIg therapy in women with refractory APS.
Our objective in this study is to determine the efficacy of IVIg therapy for refractory obstetric APS.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Live birth rate after 30 weeks of gestation
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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 (FHB).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion 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.
Key exclusion 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
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Murashima
Organization National Center for Child Health and Development
Division name Center of Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
Address 2-10-1, Okura Setagaya, Tokyo, Japan
TEL 03-3416-0181
Email murashima-a@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kayoko Kaneko
Organization National Center for Child Health and Development
Division name Division of Maternal Medicine, Center of Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
Address 2-10-1, Okura Setagaya, Tokyo, Japan
TEL 03-3416-0181
Homepage URL
Email kaneko-ky@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant, Diagnosis and treatment of antiphospholipid syndrome in obstetric field
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立成育医療研究センター病院(東京都)、大阪府立母子保健総合医療センター(大阪府)、順天堂大学医学部付属順天堂医院(東京都)、名古屋市立大学医学部付属病院(愛知県)、山形大学医学部付属病院(山形県)、愛媛大学医学部付属病院(愛媛県)、北里メディカルセンター(埼玉県)、大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 24 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015764

Research Plan
Registered date File name
2016/09/24 ②研究計画書20160917修正.docx

Research case data specifications
Registered date File name
2016/09/24 APS研究登録時症例報告書20140703最終20160402改変.docx

Research case data
Registered date File name
2016/09/24 APS研究報告書(治療開始前~投与後1-2日目)20140624最終20160517改変.docx


Contact us.