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IRCT20230419057959N1 IRCT 2023-07-09 Mashhad University of Medical Sciences Investigating the effect of probiotics on the postpartum quality of life Investigating the Effect of Oral Probiotic Capsules on Postpartum Quality of Life in Primiparous women 2023-07-23 anticipated 60 Complete https://irct.ir/trial/69683 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of assigning people to two groups (the intervention group of 30 people and the second group of 30 people) will be randomly and using the block method with blocks of 4 and 15 blocks of 4 will be done. Randomization according to the previously randomized list will be done by the statistics consultant using the random number table or R software and will be given to the researcher. Considering that the block size is 4, we will have 6 different combinations of 2 intervention groups, which we enter in the block variable. In the next step, we take a random sample of 15 of these combinations. To complete our randomization list. Commands in R are shown: bloks<-c("AABB","ABAB","ABBA","BABA","BABA","BBAA") n=15 list<-sample(bloks,n,replace=TRUE) list "AABB" "BABA" "BABA" "BABA" "ABAB" "BBAA" "AABB" "BABA" "BBAA" "BABA" "ABBA" "ABAB" "BBAA" "BABA" "ABAB" The method of assigning people to two groups will be randomly and using the block method with blocks of 4. For concealment, we use concealment allocation in such a way that the assigned group is not known before assigning the individual. By using non-transparent and closed envelopes with a random sequence of envelopes opaque, sealed, numbered sequentially (in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order ). In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. The lids of the envelopes are glued and placed in a box respectively. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: People in the placebo group will receive a capsule with the same smell, color, shape and size as the medicine capsule of the test group. In order to eliminate the bias caused by the awareness of the patient or the researcher, the study was conducted in a double-blind manner. 2 Condition 1: Mood and psychological symptoms after childbirth. Condition 2: Physical symptoms after childbirth. Condition 3: Quality of life after childbirth. Condition 4: Social support after childbirth. Condition 5: Measuring physical activity. Condition 6: Pittsburgh Sleep Quality Survey. Intervention 1: Intervention group: Daily consumption of one Bioflora probiotic capsule from Tekgen Biot company with a dose of 1.8 containing effective ingredients of Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium longum from the fifth day after delivery to four weeks after taking the medicine. Intervention 2: Control group: Daily consumption of one Avicel capsule with a similar appearance to the medicine of the intervention group from the fifth day after delivery to four weeks after starting to take the capsules. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Nahid Jahani Shorab
Ebnesina St.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 jahanishn@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Jahani Shorab
Ebnesina Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 jahanishn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iranian and resident of Mashhad primiparous age 18-35 No current illness and no history of depression and mental illnesses during pregnancy (including anxiety disorders and postpartum grief and mental illnesses acknowledged by the mother herself, Any type of mental disorder that has led to outpatient or inpatient drug treatment) Obtaining a "less than severe" score from the DASS21 questionnaire in the subscale of Depression (score zero to 20), anxiety (score zero to 14) and stress (score zero to 25) Not having a chronic disease (including: chronic heart and lung diseases, kidney, diabetes, blood pressure, cancer, diseases, rheumatism, immune deficiencies (allergy and asthma confirmed by a doctor), anemia and any disease that has lasted more than three months) No smoking and alcohol and Tobacco singleton pregnancy The birth of a healthy and mature baby with a weight of 2500 to 4000 grams Not using probiotics from 2 weeks before the start of the intervention during low-risk pregnancy and delivery without complications (absence of premature delivery, pre-eclampsia, eclampsia, blood pressure during pregnancy, gestational diabetes, infectious diseases such as hepatitis or AIDS, Not having an IUGR fetus, liver disorders (pregnancy fatty liver), polyhydraminosis and oligohydraminosis, placenta provia and placental adhesion. vaginal delivery without 3rd and 4th degree rupture) vaginal birth Living with a spouse Absence of the fetus suffering from any abnormality during pregnancy (any type of abnormality and disorder detected in pregnancy screening tests and ultrasounds) 18 years 35 years Female The unwillingness of the mother to participate in the study Unfortunate events in the last three months (suffering from mental illness, serious illness of oneself or spouse, death of a close relative, unemployment, accident, and severe family disputes) Failure to breastfeed the baby for any reason Postpartum complications (postpartum bleeding, hysterectomy, infection, and hospitalization of the mother or baby for any reason) A newborn suffering from jaundice and any other problems (heart, respiratory problems) Mother's breastfeeding problems that cause the inability to breastfeed the baby Death of a baby Taking antibiotics at the same time as taking probiotics A baby with an abnormality (any type of abnormality diagnosed by a doctor) Treatment - Drugs Placebo Intervention group: Daily consumption of one Bioflora probiotic capsule from Tekgen Biot company with a dose of 1.8 containing effective ingredients of Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium longum from the fifth day after delivery to four weeks after taking the medicine. Control group: Daily consumption of one Avicel capsule with a similar appearance to the medicine of the intervention group from the fifth day after delivery to four weeks after starting to take the capsules Quality of life after childbirth. Timepoint: 3rd to 5th day after delivery, 10-14 days after delivery, 30 days after taking medicine. Method of measurement: Postnatal Quality Of Life Specialized Questionnaire. Improvement of mood and psychological symptoms after childbirth. Timepoint: 3rd to 5th day after delivery, 10-14 days after delivery, 30 days after taking medicine. Method of measurement: A specific measuring tool for the quality of life after childbirth, the Edinburgh Depression Questionnaire. Improvement of physical symptoms after childbirth. Timepoint: 3rd to 5th day after delivery, 10-14 days after delivery, 30 days after taking medicine. Method of measurement: A specific measuring tool for the quality of life after childbirth, the Edinburgh Depression Questionnaire. Mashhad University of Medical Sciences Approved 2023-05-30 Ethics Committee of Mashhad University of Medical Sciences Ebnesina St. Mashhad Razavi Khorasan Iran (Islamic Republic of)