ISRCTN23947730已完成2 期
Chronic Endometritis and Recurrent Miscarriage
niversity Hospitals Coventry and Warwickshire NHS Trust0 个研究点目标入组 737 人开始时间: 2019年9月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 737
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-081470 (added 04/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Inclusion criteria - screening
- •1. Age > = 18 to < 42
- •2. Two or more consecutive first trimester miscarriages
- •3. Women who agree to use barrier methods of contraception during the following cycles: biopsy preparation, screening-biopsy, waiting for the results and during the intervention
- •Inclusion criteria - RCT
- •1. Women with > = 5 CD138+ cells/10mm2
排除标准
- •Current participant exclusion criteria as of 17/08/2021:
- •Exclusion criteria– screening:
- •1. Known treatable cause(s) of RM. Participants may not have undergone tests for treatable causes of RM prior to registration. If
- •a treatable cause for RM is identified after registration, the participant cannot be randomised.
- •1.1. Antiphospholipid antibody syndrome
- •1.2. Thyroid disease
- •1.3. Parental karyotypical abnormalities.
- •2. Known sub-septate uterus.
- •3. Poorly controlled diabetes (HbA1c >48 mmol/mol)
- •4. Allergy to doxycycline or its excipients
- •5. Doxycycline contraindicated
- •6. Antibiotics in the current menstrual cycle
- •7. Taking a medication that may interact with doxycycline
- •8. Myasthenia Gravis.
- •9. Systemic lupus erythematosus (SLE)
- •10. Immunodeficiency disorder
- •11. Known serious liver disease as judged by a medically qualified doctor assessing trial eligibility informed by referral letter from GP and hospital records
- •12. Alcohol dependency as judged by a medically qualified doctor assessing trial eligibility informed by referral letter from GP and hospital records
- •13. Long-term antibiotic(s) use.
- •14. Menstrual cycle =21 or =42 days
- •15. Any co-morbid disease or condition that would make the patient unsuitable for the trial as judged by a medically qualified doctor assessing trial eligibility informed by referral letter from GP and hospital records
- •16. Unable to give informed consent.
- •17. Participation in another clinical trial of an investigational medicinal product (CTIMP) within the last 90 days.
- •18. Breast feeding
- •19. Pregnancy
- •Exclusion criteria– RCT:
- •1. Treatable cause(s) of RM
- •2. A course of antibiotics between screening registration and randomisation to RCT. If a woman has a course of antibiotics between screening registration and randomisation they will not be eligible for trial randomisation at the time but should be given the option to re-screen and have another biopsy to confirm eligibility for randomisation.
- •3. A delay of longer than three months between biopsy result and randomisation to RCT. If a woman was registered for screening over three months before randomisation to the RCT they will not be eligible for trial randomisation at the time but should be given the option to re-screen and have another biopsy to confirm eligibility for randomisation.
- •4. Known serious liver disease as judged by a medically qualified doctor assessing trial eligibility informed by referral letter from GP and hospital records
- •5. Taking a medication that may interact with doxycycline
- •6. Any co-morbid disease or condition that would make the patient unsuitable for the trial as judged by a medically qualified doctor assessing trial eligibility informed by referral letter from GP and hospital records
- •7. Pregnancy
- •If a clinician has doubts about a participants’ suitability for the trial because of a long-term medical condition they should undertake a Full Blood Count (FBC) and Liver function tests (LFTs); in order for a woman to be included in the trial the following should apply and all required additional checks must be documented in the patients’ medical notes:
- •1. WBC >3 x10?/l
- •2. Neutrophils >1.5 x10?/l
- •3. Platelets >75 x10?/l and hemoglobin (Hb) >100 g/l
- •4. Bilirubin <1.5 x upper limit of normal (ULN)
- •5. AST/ALT <3 x ULN
- •6. Albumin >30 g/dl
- •Previous participant exclusion criteria:
- •Exclusion criteria – screening
- •1. Treatable cause(s) of RM for example:
- •1.1. Antiphospholipid antibody syndrome
- •1.2. Thyroid disease
- •1.3. Parental karyotypical
研究者
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