Folate trial for recurrent miscarriage

Not Applicable

• Conditions: Recurrent Miscarriage; Reproductive Health and Childbirth - Abortion; Reproductive Health and Childbirth - Fertility including in vitro fertilisation; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622001577707
• Lead Sponsor: niversity of Technology Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Women aged 20-49 years of age with two or more pregnancy losses before 22 weeks and their reproductive partners
2. Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent
3. Ability to attend a pathology centre for specimen collection
4. Ability to not take concomitant medications, vitamins, food containing folic acid

Exclusion Criteria

1. Pregnant or lactating women
2. Couples who are currently undergoing assisted reproductive technologies
3. Men and women taking folate antagonist medication (phenytoin, valproic acid, valproate sodium, carbamazepine, methotrexate, trimethoprim hydrochloride, trimethoprim sulphate, trimethoprim, aminopterin sodium, phenobarbital, phenobarbital sodium, primidone, divalproex)
4. Individuals with a known sensitivity to any ingredients in the products
5. History or presence of psychiatric disorders (including depression and severe anxiety), autoimmune disease, and cancer
6. History of gynaecological and/or genetic problems– antiphospholipid syndrome, blocked fallopian tubes, Pelvic inflammatory disease, Primary ovarian insufficiency, endometriosis, Uterine fibroids, Factor V Leiden

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility determined by an audit of participant adherence to their allocated treatment, which will be assessed using participant self-report.<br><br><br><br><br><br> <br><br><br><br>[At 9 months after randomisation]