spontaneous preterm birth
Conditions
Interventions
experimental group :Vaginal flora transplantation
Sponsors
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subject: (1) Premenopausal women aged 18 to 50 years; (2) A history of repeated miscarriage or preterm delivery considered infection-related and abnormal detection of vaginal flora; (3) Women of childbearing age who have a pregnancy plan should sign informed consent; (4) In good health, free from immune system diseases or other chronic diseases; (5) Be willing to be asked about personal issues such as medical history, current medication use, sexuality and sexual behavior. 2. Donor: (1) Premenopausal women aged 18 to 50 years; (2) In good health, free from immune system diseases or other chronic diseases; (3) Be willing to be asked about personal issues such as medical history, current medication use, sexuality and sexual behavior; (4) No plans to get pregnant within a year.
Exclusion criteria
Exclusion criteria: 1. Subject: (1) Pregnant or lactating subjects; (2) Known positive HIV/AIDS infection or other immune diseases; (3) Infection: HIV, hepatitis A, B and C, chlamydia, gonorrhea, mycoplasma, trichomonas, HPV positive; (4) Have participated in other medical studies within the past 30 days; (5) IUD removal, cervical cryotherapy or cervical laser treatment within 3 months; (6) Use antibiotics or probiotics during the investigation or within one month before the collection of vaginal secretions; (7) Use of long-acting hormone therapy within 3 months; (8) Any social, medical or psychological condition, including any history of drug and alcohol abuse. 2. Donor: (1) Pregnant or lactating subjects; (2) Any history of bacterial vaginosis, trichomoniasis, syphilis, HPV, herpes, intraperitoneal infection, repeated urine infection, or mycoplasma infection; (3) Positive for HIV, hepatitis A, B and C, chlamydia, gonorrhea, mycoplasma, Trichomonas, HPV, herpes simplex and Streptococcus A, B, C and G; (4) Hysterectomy; (5) Have participated in other medical studies within the past 30 days; (6) IUD removal, cervical cryotherapy or cervical laser treatment within 3 months; (7) Use antibiotics or probiotics during the investigation or within one month before the collection of vaginal secretions; (8) Use of long-acting hormone therapy within 3 months; (9) Any social, medical or psychological condition, including any history of drug and alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal secretions;Gestational week of delivery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Birth weight of newborn;Five minute Apgar score;Neonatal respiratory distress syndrome;Neonatal mortality;Composite neonatal morbidity/mortality; | — |
Countries
China
Contacts
Public ContactJiang Xiang
Department of Obstetrics, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Outcome results
None listed