A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone on recurrent spontaneous abortion with undifferentiated connective tissue diseases: Protocol for the immunosuppressant regimens for Living FEtuses (ILIFE) Trial

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 suppressant 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. Trial registration: ClinicalTrials.gov, NCT03671174. Registered on 14 September 2018. https://www.clinicaltrials.gov/ct2/show/NCT03671174

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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 ◽

10.1186/s13063-020-04716-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Shaoying Yang ◽

Ruoning Ni ◽

Yikang Lu ◽

Suli Wang ◽

Feng Xie ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Connective Tissue ◽

Pregnancy Outcomes ◽

Pregnancy Loss ◽

Low Dose ◽

Controlled Trial ◽

Open Label ◽

Randomized Controlled ◽

Adverse Pregnancy ◽

Dose Prednisone

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. Trial registration ClinicalTrials.gov NCT03671174. Registered on 14 September 2018.

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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

10.21203/rs.2.13361/v3 ◽

2020 ◽

Author(s):

Shaoying Yang ◽

Ruoning Ni ◽

Yikang Lu ◽

Suli Wang ◽

Feng Xie ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Connective Tissue ◽

Pregnancy Outcomes ◽

Pregnancy Loss ◽

Low Dose ◽

Controlled Trial ◽

Open Label ◽

Randomized Controlled ◽

Adverse Pregnancy ◽

Dose Prednisone

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 suppressant 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. Trial registration: ClinicalTrials.gov, NCT03671174. Registered on 14 September 2018. https://www.clinicaltrials.gov/ct2/show/NCT03671174

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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

10.21203/rs.2.13361/v4 ◽

2020 ◽

Author(s):

Shaoying Yang ◽

Ruoning Ni ◽

Yikang Lu ◽

Suli Wang ◽

Feng Xie ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Connective Tissue ◽

Pregnancy Outcomes ◽

Pregnancy Loss ◽

Low Dose ◽

Controlled Trial ◽

Open Label ◽

Randomized Controlled ◽

Adverse Pregnancy ◽

Dose Prednisone

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 suppressant 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. Trial registration: ClinicalTrials.gov, NCT03671174. Registered on 14 September 2018. https://www.clinicaltrials.gov/ct2/show/NCT03671174

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Efficacy of Intrauterine Perfusion of Cyclosporin A for Intractable Recurrent Spontaneous Abortion Patients With Endometrial Alloimmune Disorders: A Randomized Controlled Trial

Frontiers in Physiology ◽

10.3389/fphys.2021.737878 ◽

2021 ◽

Vol 12 ◽

Author(s):

Long Zhao ◽

Lijuan Qi ◽

Jinhua Fu ◽

Shuqin Bi ◽

Lin Li ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Placebo Group ◽

Cyclosporin A ◽

Spontaneous Abortion ◽

Luteal Phase ◽

Controlled Trial ◽

Recurrent Spontaneous Abortion ◽

Main Study ◽

Menstrual Cycles ◽

Randomized Controlled

ObjectiveTo explore the therapeutic efficacy of intrauterine perfusion of cyclosporin A (CsA) in intractable recurrent spontaneous abortion (RSA) patients with endometrial alloimmune dysfunction.MethodsThis is a randomized controlled trial (RCT) of patients with intractable RSA with endometrial alloimmune disorders. A total of 201 women were enrolled, all of whom had at least 3 serial abortions and endometrial alloimmune dysfunction. Participants were randomly assigned to two groups. The CsA group (n = 101) received intrauterine infusion of 250 mg CsA on the 3rd and 7th days after menstruation for 2 menstrual cycles, while the placebo group (n = 100) received placebo. The birth of healthy, deformity-free babies was the main study outcome.ResultsIn total, 75 (74.26%) women in the CsA group and 59 (59.00%) women in the placebo group gave birth to healthy babies [P = 0.01, OR = 2.01; 95% CI (1.10∼3.65)]. Compared to the placebo group, the CsA group had dramatically lower endometrial CD56+ cell and CD57+ cell concentrations at the luteal phase of the second menstrual cycle (P < 0.05).ConclusionIntrauterine perfusion of CsA was confirmed to be a promising approach for the treatment of intractable alloimmune RSA.

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