healthy pregnant women
Conditions
Interventions
Control group:Blank control
Test group:Freshly stewed bird’s nest (70 g). After randomization, one bottle shall be taken orally daily for a total of 6 weeks.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy pregnant women aged between 20 and 35 years old. 2. At 6–8 weeks of gestation with a singleton pregnancy, gestational age confirmed by ultrasound consistent with gestational sac size. 3. Mild to moderate pregnancy reaction assessed by the PUQE scale. 4. No previous history of bird’s nest allergy, voluntarily participating in this trial, signing the informed consent form, and being able to cooperate with the corresponding food trial process and various examinations in each group.
Exclusion criteria
Exclusion criteria: 1. History of in vitro fertilization (IVF), multiple pregnancy, or adverse pregnancy outcomes; 2. Individuals with severe organic diseases of vital organs such as the heart, liver, kidney, and lungs; 3. Presence of uterine fibroids with a diameter of 3 cm or larger; 4. At screening, having diseases that may exacerbate early pregnancy reactions, including severe cardiovascular and cerebrovascular diseases, digestive system diseases (e.g., gastrointestinal diseases, hepatobiliary diseases, pancreatic diseases), hematological and lymphatic system diseases, liver and kidney dysfunction, endocrine system diseases, immune system diseases, and neurological/neuropsychiatric disorders; 5. Individuals with a history of major diseases, or those with positive results for any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; individuals with a history of Helicobacter pylori infection; 6. Individuals with a history of mental illness, cognitive impairment, or inability to communicate effectively; 7. Individuals with unhealthy lifestyles such as alcohol abuse and smoking, or a history of drug abuse; 8. Individuals deemed ineligible for participation in this trial or at high risk of loss to follow-up by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy Stress Rating Scale (PSRS);Scale Score for the Impact of Nausea and Vomiting in Early Pregnancy on Quality of Life (PUQE);Pittsburgh Sleep Quality Index (PSQI);Serum estradiol;Progesterone level;Serum human chorionic gonadotropin;Serum sialic acid concentration;Thyroid-Stimulating Hormone (TSH);Free Thyroxine (FT4);Gut microbiota diversity (16S RNA sequencing);Uterine artery blood flow;Free Thyroxine (FT4); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Four items of blood lipid profile; | — |
Countries
China
Contacts
Public ContactZhou Huan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed