scholarly journals Efficacy of 4.0 mg versus 0.4 mg Folic Acid Supplementation on the Reproductive Outcomes: A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4422
Author(s):  
Renata Bortolus ◽  
Francesca Filippini ◽  
Sonia Cipriani ◽  
Daniele Trevisanuto ◽  
Francesco Cavallin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Folic Acid ◽  
Pregnancy Outcomes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Adverse Pregnancy Outcomes ◽  
Composite Outcome ◽  
Reproductive Outcomes ◽  
Randomized Controlled ◽  
Adverse Pregnancy

Folic acid (FA) supplementation prevents neural tube defects (NTDs), but the effects on other reproductive outcomes are unclear. While common recommendation is 0.4 mg/day in addition to regular nutrition, the most appropriate dose of FA is still under debate. We investigated the effects of a higher dose of periconception FA on reducing adverse reproductive outcomes. In this multicenter double-blind randomized controlled trial (RCT), 1060 women (aged 18–44 years and planning a pregnancy) were randomly assigned to receive 4.0 mg or 0.4 mg of FA daily. The primary outcome was the occurrence of congenital malformations (CMs). A composite outcome including one or more adverse pregnancy outcomes was also evaluated. A total of 431 women had a natural conception within 1 year. The primary outcome occurred in 8/227 (3.5%) women receiving 4.0 mg FA and 9/204 (4.4%) women receiving 0.4 mg FA (RR 0.80; 95%CI 0.31 to 2.03). The composite outcome occurred in 43/227 (18.9%) women receiving 4.0 mg FA and 75/204 (36.8%) women receiving 0.4 mg FA (RR 0.51; 95%CI 0.40 to 0.68). FA 4.0 mg supplementation was not associated with different occurrence of CMs, compared to FA 0.4 mg supplementation. However, FA 4.0 mg supplementation was associated with lower occurrence of other adverse pregnancy outcomes.

scholarly journals 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 ◽  
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.

scholarly journals 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

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

scholarly journals 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

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

scholarly journals Lifting and pregnancy outcomes: feasibility of a randomized controlled trial

2017 ◽  
Vol 68 (1) ◽  
pp. 11-17
Author(s):  
E Kwegyir-Afful ◽  
J Verbeek ◽  
L Aziato ◽  
J D Seffah ◽  
K Vehviläinen-Julkunen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Randomized Controlled

Effects of nurse home visitation on cigarette smoking, pregnancy outcomes and breastfeeding: A randomized controlled trial

Midwifery ◽  
2014 ◽  
Vol 30 (6) ◽  
pp. 688-695 ◽  
Author(s):  
Jamila Mejdoubi ◽  
Silvia C.C.M. van den Heijkant ◽  
Frank J.M. van Leerdam ◽  
Matty Crone ◽  
Alfons Crijnen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cigarette Smoking ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Home Visitation ◽  
Nurse Home ◽  
Randomized Controlled

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

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