Condition 1: Preterm birth. Condition 2: Postpartum Depression. Preterm labor Other depressive episodes
Conditions
Interventions
Intervention 1: Women in the intervention group will receive probiotic supplements, in 500 mg capsules, containing the microorganisms Lacticaseibacillus paracasei subsp. Paracasei and Bifidobacterium
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
17 Years to 45 Years
Inclusion criteria
Inclusion criteria: Gestational age of 22 to 26 weeks based on ultrasound under 12 weeks or LMP Being at risk of preterm birth, ie, having at least one of the following characteristics: history of preterm birth under 37 weeks or fetal loss after 16 weeks of pregnancy, cervical length less than 25 mm according to ultrasound results, twin, aged under 17 or over 35 years, cervical cerclage in the current pregnancy, smoking, less than 6 months interval between pregnancy and previous delivery, pre-pregnancy body mass index > 30 or < 18.5 kg/m2 and above, bacteriuria in the current pregnancy; or a history of hospitalization with symptoms/signs of threatened preterm birth, provided that suppression of the symptoms with tocolytic drugs (such as magnesium sulfate/nifedipine) in the current pregnancy.
Exclusion criteria
Exclusion criteria: Pregnancy after in vitro fertilization Premature rupture of membranes (PROM) Known important medical problems such as chronic hypertension, diabetes, diseases of the thyroid or liver Acute symptoms of premature labor Known major fetal abnormalities Known abnormalities of the woman uterus Regular consumption of probiotics or having a history of sensitivity to probiotics Drug or alcohol addiction Triplets or more Inflammatory bowel disease (as diagnosed by a specialist) Participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrauterine age of newborn. Timepoint: at birth. Method of measurement: Assessment of mother/infant medical record.;Postpartum depression. Timepoint: Before the intervention (baseline), one month of the intervention, 40-45 days after delivery. Method of measurement: Using the Edinburgh Postpartum Depression Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant birth weight. Timepoint: At birth. Method of measurement: Using a digital scale.;Phototherapy of the newborn. Timepoint: 40-45 days after the childbirth. Method of measurement: Examining the infant's medical record or asking the mother.;Duration of newborn phototherapy (hours). Timepoint: During neonatal period or 40-45 days after the childbirth. Method of measurement: Examining the infant's medical record or asking the mother.;Duration of infant hospitalization. Timepoint: at 40-45 days after the childbirth. Method of measurement: Examining the infant's medical record or asking the mother.;Infant weight gain in 40-45 days after birth. Timepoint: At birth, 40-45 days after birth. Method of measurement: Using a digital scale.;The composite variable of occurrence of serious problems in hospitalized newborns (including dysplasia, bronchopulmonary, sepsis, necrotizing enterocolitis, and retinopathy of prematurity). Timepoint: 7-10 days and 40-45 days after birth. Method of measurement: Diagnosed by neonatologist and ophthalmologist based on clinical and para-clinical assessments (Retinopathy of prematurity will be assessed by an ophthalmologist after 28 days of infancy).;The composite variable of occurrence of some neonatal problems including Apgar score less than 7 in the fifth minute, hospitalization in NICU, use of surfactant, intubation, mechanical ventilation, and use of Continuous Positive Air Pressure (CPAP). Timepoint: For infants who have been hospitalized for more than 48 hours, during neonatal hospitalization; for the rest, 40-45 days after childbirth. Method of measurement: For infants who have been hospitalized for more than 48 hours, by examining the infant's medical record and asking the neonatologist, if needed; for the rest, by asking mothers.;Appropriate weight gain of women during pregnancy. Timepoint: At baseline, maximum 10 days before delivery. Method of measurement: Weighting using a digital scale and comparison of the weight gain with the | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Alikamali
Tabriz University of Medical Sciences
Outcome results
None listed