healthy pregnant women
Conditions
Interventions
Control group:Blank control
Test group:Fresh stewed bird's nest (70 g). After randomization, take one bottle orally daily, and continue administration until 24 weeks postpartum.
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 between 20 and 35 years of age; 2. Be in the 24th to 28th week of pregnancy, single pregnancy, confirmed by ultrasound examination that the gestational week and the size of the foetus are in line with each other and there is no structural abnormality; 3. Not taking bird's nest for a long period of time before pregnancy or during early pregnancy. In case of experimental group, it is expected that the patient can continue to take bird's nest after delivery and complete the follow up; the control group should promise not to take bird's nest and similar tonic products during the observation period; 4. No history of allergy to bird's nest and related products (control group does not need this criterion, but should confirm that they have no history of allergy to similar food); 5. Trial participants agree to use basic skin care products (fragrance-free and hormone-free) for their newborns during the trial period, and do not use prescriptions (e.g. herbal remedies, breastmilk applied to the skin, etc.), and promise to avoid exposing their newborns to strong ultraviolet rays and smoke for a long period of time; 6. Voluntarily participate in this trial and sign the informed consent form, and be able to co-operate with the completion of the corresponding trial food process and various tests in each group.
Exclusion criteria
Exclusion criteria: 1. History of multiple pregnancies and preeclampsia; 2. Presence of uterine fibroids with a diameter of 3cm or more; 3. History of severe cardiovascular or cerebrovascular disease, gastrointestinal disease (gastrointestinal, hepatobiliary, pancreatic), diabetes mellitus, immune system disease, neurological/psychiatric disorders, or a positive test result for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV), HIV, or Syphilis Spirochaete; 4. Those with a history of mental illness, cognitive impairment or inability to communicate effectively; 5. skin abnormalities in the abdomen, such as inflammation, eczema, psoriasis, skin cancer, etc; 6. current or past 3 months topical application of retinoic acid, alpha hydroxy acid or beta hydroxy acid; 7. Participation in other clinical trials within the last 6 months; 8. the presence of alcoholism, smoking and other bad habits, or a history of drug abuse; 9. those who, in the judgement of the investigator, are not suitable for participation in this trial or are vulnerable to loss of visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum sialic acid concentration;Gut microbiota: 16S amplicon sequencing;Fecal metagenomic sequencing;Fetal development: Biparietal diameter, head circumference, abdominal circumference, femur length.;Breast milk sialic acid concentration;Pregnancy Related Anxiety Questionnaire (PAQ);Pregnancy swelling degree; Uterine artery blood flow;Maternal immunity: IgG, IgA, IL-6;Visual inspection and image acquisition of abdominal striae gravidarum;Pittsburgh Sleep Quality Index (PSQI);Montreal Cognitive Assessment (MoCA);Syndrome Questionnaire of Qi and Blood;Plasma free nucleic acid detection; Metabolome;Breast milk immunity: IgG, IgA, IL-6;Edinburgh Postnatal Depression Scale (EPDS);Time of lochia discharge completion;Neonatal Score (APGAR Score); Neonatal physical examination;Neonatal intellectual level;Neonatal Immunity; Neonatal Intestinal Health; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight;Fasting blood glucoseBlood lipidsUrine routine test;Skin condition; | — |
Countries
China
Contacts
Public ContactZhou Huan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed