UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013496 |
|---|---|
| Receipt number | 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 | 2023/03/15 12:39:00 |
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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 | Obstetrics 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 | Atsuko |
| Middle name | |
| Last name | Murashima |
Organization
National Center for Child Health and Development
Division name
Center of Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
1578535
Address
2-10-1, Okura Setagaya, Tokyo, Japan
TEL
0334160181
kaneko-ky@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | 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
1578535
Address
2-10-1, Okura, setagaya-ku
TEL
0334160181
Homepage URL
kaneko-ky@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
Certified Clinical Research Review Board, National Center for Child Health and Development
Address
2-10-1, Okura, setagaya-ku
Tel
0334160181
rinken@ncchd.go.jp
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）、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）、大阪医科薬科大学（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
8
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/15764
