Pregnancy Sleep Disorders (Pregnancy Sleep Disorders, PSD)
Conditions
Interventions
Sleep Disorders Group:postbiotic
control group:placebo
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Permanent residents of our country (residing for more than 6 months); 2.Age range of 18-45 years old (including both ends) during screening; 3.Gestational weeks 28-34 weeks; 4.Establish prenatal examination records at the First Affiliated Hospital of Chongqing Medical University and Jinshan Hospital; 5.Regular prenatal check ups; 6.Can fill out electronic questionnaires; 7.Voluntarily sign an informed consent form before the start of activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial; 8.Based on past medical history, physical examination, vital signs, laboratory tests, and electrocardiogram examination, participants were judged to be overall healthy by the researchers.
Exclusion criteria
Exclusion criteria: 1.Age<18 years old; 2.Gestational age<28 weeks; 3.Unable to conduct regular prenatal check ups; 4.Patients with major diseases such as gynecological tumors, intestinal organic diseases, infectious diseases, and mental illnesses; 5.Previous allergies to probiotics or epigenetic drugs, or serious adverse drug reactions; 6.Unable to take Postnatal Elements due to physical reasons; 7.Currently or recently planning to participate in any other clinical trials that may affect the results of this study; 8.Not willing to take prebiotics or collect biological samples; 9.There is a risk of poor compliance and/or inability to complete the trial, including but not limited to: evidence of mental disability, involuntary or uncooperative attitudes, language barriers that hinder full understanding of the trial (including lack of literacy); 10.Patients who have a history of taking probiotics, prebiotics, or antibiotics within one month prior to participating in the study 11.Judged by the researcher to have any other interference with the evaluation of the test results or are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and therapeutic effects of PSD in pregnant women; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcome;Neonatal birth outcomes; | — |
Countries
China
Contacts
Public ContactShan Nan
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed