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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230419057959N1
Enrollment
60
Registered
2023-07-09
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

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, Bifid

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Jahani Shorab

Mashhad University of Medical Sciences

jahanishn@mums.ac.ir+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026