Ischemic diseases
Conditions
Interventions
Ischemic disease observation group:None
Sponsors
Beijing Luhe Hospital, Affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 38 Years
Inclusion criteria
Inclusion criteria: 1. Women who have reached the legal age for marriage and childbirth (over 20 years old) and whose expected age of delivery is under 38 years old (inclusive of 38 years old); 2. Normal full-term singleton pregnancies after 37 weeks and before 40+3 weeks of gestation; 3. Natural pregnancies without the use of medical assisted reproductive technologies such as artificial insemination or in vitro fertilization; 4. The mother has been in good health in the past and has no history of infectious diseases, and the infectious disease screening during pregnancy includes: Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Treponema pallidum (TP), with negative test results; 5. The vital signs, physical examination, blood routine, blood type, comprehensive biochemical tests, urine routine, and 12-lead electrocardiogram during pregnancy show normal or no clinically significant abnormalities; 6. The B-ultrasound examination during pregnancy shows that the position of the umbilical cord attachment is normal, and no abnormal shapes such as sail-shaped placenta or ball-shaped placenta are shown; 7. The donor voluntarily participates in the trial, signs a written informed consent form, and can follow the trial protocol to complete the trial, that is, agrees to collect 6 mL of venous blood for rechecking the pathogenology one day before the surgery and at 90-97 days after delivery (window period); 8. The newborn's weight should be greater than 2.5 kilograms and no more than 4.5 kilograms; 9. The newborn examination is normal, including no body deformities, normal skin color, etc.; 10. There is no severe edema or obvious deformity of the placenta and umbilical cord; 11. The diameter of the placenta is 15-25 cm, the thickness is 2-3 cm, the appearance is bright, the amniotic membrane on the fetal side is transparent, the tissue has no abnormal calcification and obvious coagulation, the umbilical cord is not twisted or knotted, and there is no coagulation in the blood vessels.
Exclusion criteria
Exclusion criteria: 1.Donors with severe comorbidities such as preeclampsia, gestational diabetes mellitus (GDM), intrahepatic cholestasis of pregnancy (ICP), and other complications that induce placental inflammatory responses including premature rupture of membranes (PROM) and chorioamnionitis. 2.Donors with uncontrollable infectious diseases during the course of pregnancy. 3.Donors with a history of substance abuse (defined as the use of illicit drugs, such as morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine (MDMA), and tetrahydrocannabinolic acid (THCA)). 4.Donors with a history of alcohol abuse or tobacco abuse within the past 2 years (Alcohol abuse is defined as consuming more than 14 alcohol units per week: 1 unit ˜ 360 mL of beer, 45 mL of spirits, or 150 mL of wine; tobacco abuse is defined as smoking =10 cigarettes per day). 5.Donors with exposure to toxic and harmful substances or ionizing radiation. 6.Donors for whom both the donor and her spouse have a family history of genetic diseases. 7.Donors who have participated in other clinical trials during the course of pregnancy. 8.Donors with complications during delivery, including grade II or higher amniotic fluid contamination, meconium contamination, intrauterine infection, or a body temperature exceeding 38?. 9.Donors in whom the investigator deems the existence of any condition that may impair the donor’s ability to provide informed consent or adhere to the trial protocol, or that the donor’s participation in the trial may compromise the trial results or the donor’s own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infectious disease screening; | — |
Countries
China
Contacts
Public ContactWu Yingfeng
Beijing Luhe Hospital, Affiliated to Capital Medical University
Outcome results
None listed