Journal article
A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial
Trials, Vol.21(1), 771
09/09/2020
DOI: 10.1186/s13063-020-04716-1
PMCID: PMC7488113
PMID: 32907619
Abstract
Background
Undifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation. Anticoagulation can prevent pregnancy morbidities. However, it is unknown whether the addition of immune suppressants to anticoagulation can prevent spontaneous pregnancy loss in UCTD patients. The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and low-dose prednisone on recurrent pregnancy loss for women with UCTD.
Methods
The Immunosuppressant for Living Fetuses (ILIFE) Trial is a three-arm, multicenter, open-label randomized controlled trial with the primary objective of comparing hydroxychloroquine combined with low-dose prednisone and anticoagulation with anticoagulation alone in treating UCTD women with recurrent spontaneous abortion. The third arm of using hydroxychloroquine combined with anticoagulant for secondary comparison. A total of 426 eligible patients will be randomly assigned to each of the three arms with a 1:1:1 allocation ratio. The primary outcome is the rate of live births. Secondary outcomes include adverse pregnancy outcomes and progression of UCTD.
Discussion
This is the first multi-center, open-label, randomized controlled trial which evaluates the efficacy of immunosuppressant regimens on pregnancy outcomes and UCTD progression. It will provide evidence on whether the immunosuppressant ameliorates the pregnancy prognosis in UCTD patients with RSA and the progression into defined connective tissue disease.
Details
- Title: Subtitle
- A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial
- Creators
- Shaoying Yang - Renji HospitalRuoning Ni - Saint Agnes HospitalYikang Lu - Renji HospitalSuli Wang - Renji HospitalFeng Xie - ImpactChunyan Zhang - Shanghai Jiao Tong UniversityLiangjing Lu - Renji Hospital
- Resource Type
- Journal article
- Publication Details
- Trials, Vol.21(1), 771
- DOI
- 10.1186/s13063-020-04716-1
- PMID
- 32907619
- PMCID
- PMC7488113
- NLM abbreviation
- Trials
- ISSN
- 1745-6215
- eISSN
- 1745-6215
- Publisher
- BioMed Central
- Grant note
- 2017YFC0909000 / ;
- Language
- English
- Date published
- 09/09/2020
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984945914802771
Metrics
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