Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347770
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-29
Brief Title:
Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women
Sponsor:
Third Affiliated Hospital Sun Yat-Sen University
Organization:
Third Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the effect of probiotics 7 days before cesarean section CS on postoperative recovery and the change of gut microbiota in pregnant women Samples were obtained from a total of 80 pregnant individuals divided into control group and probiotics group Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them
Detailed Description:
Study design and participants A total of 80 samples were obtained from pregnant individuals receiving antenatal care at the 3rd Affiliated Hospital of Sun Yat-sen University and the 1st Affiliated Hospital of Jinan University Informed consent was obtained from pregnant women at least 32 gestational weeks who met the inclusion criteria Pregnant women were followed until 7 days after cesarean section Pregnant inclusive criteria were 1 Chinese woman who is pregnant with a single fetus 2 Pregnant women who planned to perform lower section of uterus due to social factors relative head basin asymmetry macrosomia cicatricial uterus and other reasons Pregnant exclusive criteria were 1 Gastrointestinal disease or family history 2 Antibiotic usage during pregnancy 3 Habit of eating foods with high probiotic content such as yogurt and cheese during pregnancy 4 Take other probiotics or probiotic drinks during pregnancy regularly 5 Hypertension Diabetes Mellitus Hyperthyroidism Hypothyroidism Autoimmune Disease or Other Endocrine and Metabolic Disease 6 Transfusion History Organ Transplantation History or Immunotherapy 7 Gestational hypertension gestational diabetes gestational thyroid dysfunction and other endocrine and metabolic diseases occurred during this pregnancy
Probiotic management In our study forty pregnant women were randomly assigned to the probiotic group and the rest were assigned to the control group After enrollment pregnant women in the probiotic group received the living Bifidobacterium longum 5 106 CFU tablets produced by Neimengu Shuangqi Pharmaceutical Co Ltd Pregnant individuals in the probiotic group were administered four tablets three times a day 2 gd for seven days before surgery until the fourth day after surgery and those in the control group took no pills
Fecal venous blood and data collection Fecal collection Feces from pregnant women were collected twice-the last time before surgery and the first time after surgery Feces collected were both collected internally thereby avoiding contamination with foreign material The feces were transferred to the laboratory freezer at 80ºC within 30 min of collection when obtained in the hospital Feces collected were stored in a domestic refrigerator and transferred to the laboratory freezer for 24 hours when obtained outside the hospital
Venous blood collection Venous blood from pregnant women was collected twice-before and after surgery The venous blood was obtained in the hospital and centrifuged within 30 minutes in a temperature-controlled centrifuge at 3000 rmin at 4 for 10 minutes after 2ml of which was collected then the serum samples were transferred to the laboratory freezer at -80ºC
Data collection Data from pregnant women was collected before and after surgery including age height pre-delivery weight time of first anal exhaust and defecation
Probiotic management In our study forty pregnant women were randomly assigned to the probiotic group and the rest were assigned to the control group After enrollment pregnant women in the probiotic group received the living Bifidobacterium longum 5 106 CFU tablets produced by Neimengu Shuangqi Pharmaceutical Co Ltd Pregnant individuals in the probiotic group were administered four tablets three times a day 2 gd for seven days before surgery until the fourth day after surgery and those in the control group took no pills
Fecal venous blood and data collection Fecal collection Feces from pregnant women were collected twice-the last time before surgery and the first time after surgery Feces collected were both collected internally thereby avoiding contamination with foreign material The feces were transferred to the laboratory freezer at 80ºC within 30 min of collection when obtained in the hospital Feces collected were stored in a domestic refrigerator and transferred to the laboratory freezer for 24 hours when obtained outside the hospital
Venous blood collection Venous blood from pregnant women was collected twice-before and after surgery The venous blood was obtained in the hospital and centrifuged within 30 minutes in a temperature-controlled centrifuge at 3000 rmin at 4 for 10 minutes after 2ml of which was collected then the serum samples were transferred to the laboratory freezer at -80ºC
Data collection Data from pregnant women was collected before and after surgery including age height pre-delivery weight time of first anal exhaust and defecation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None