Recurrent spontaneous abortion
Conditions
Interventions
Control Group:Control group treatment details as above
Treatment group:Treatment group details as above
Sponsors
Changzhou Affiliated Hospital of Nanjing University of Chinese Medicine (Changzhou Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1: Meet TCM and Western diagnostic criteria: Western criteria (per Obstetrics & Gynecology 9th ed, 2022 Recurrent Abortion Expert Consensus): - =2 consecutive pregnancy losses before 28 weeks - Insulin resistance criteria (any one): a) Fasting insulin =15 mIU/L b) Insulin peak >10× fasting level c) Delayed peak (120/180 min) d) Insulin not returning to fasting level at 180 min TCM criteria (liver depression-spleen deficiency): Main symptoms: =2 consecutive abortions Secondary symptoms: Specific body types with characteristic symptoms Tongue/pulse: Pale red tongue with thin white coating/wiry pulse; or pale tongue with teeth marks/slippery pulse
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1: Chromosomal abnormalities in either parent 2: Severe congenital defects/uterine adhesions 3: Endocrine disorders (FSH>25mIU/mL, etc.) 4: Autoimmune antibodies positive 5: Abnormal sperm DNA fragmentation 6: Severe organ dysfunction 7: Participating in other trials 8: Investigator-deemed ineligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live Birth Rate: The proportion of live-born infants delivered within 2 years after enrollment.;Interim objective: Pregnancy reaching or exceeding 28 weeks with the foetus in good condition.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal complications: observed from the confirmation of pregnancy to 24 hours postpartum, including the occurrence of preeclampsia, gestational diabetes, placental abruption, placenta previa hemorrhage, and other related diseases.;Fetal/neonatal outcomes: Incidence of growth restriction, prematurity, amniotic fluid disorders with neonatal parameters;TCM Syndrome Score;Insulin Release Test Results;Peripheral blood mitochondrial DNA relative copy number;Serum ATP, ADP, AMP levels; | — |
Countries
People's Republic of China
Contacts
Public ContactLi Shuping
Changzhou Affiliated Hospital of Nanjing University of Chinese Medicine (Changzhou Hospital of Traditional Chinese Medicine)
Outcome results
None listed