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IRCT20100414003706N43 IRCT 2022-11-26 Tabriz University of Medical Sciences Effect of probiotic administration to women at risk of preterm birth on some neonatal and maternal outcomes Effect of probiotic administration to women at risk of preterm birth on some neonatal and maternal outcomes: a randomized controlled clinical trial 2022-12-22 anticipated 72 Complete https://irct.ir/trial/65425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Women at risk of preterm birth will be equally allocated into the probiotic or placebo groups using stratified (recruited center [health center/hospital], singleton/twin pregnancy) block randomization (with block sizes of 4 & 6) referring to a computerized program, Blinding description: Identical, opaque, sequentially numbered bottles containing probiotic/placebo capsules will be utilized to conceal the allocation and ensure blinding. The sequence generation and preparation of the bottles will be done by a person not involved in the recruitment, the prescription, and data collection. The investigators, health care providers, outcome assessors, and statistical analysts will be blinded. 3 Condition 1: Preterm birth. Condition 2: Postpartum Depression. Intervention 1: Women in the intervention group will receive probiotic supplements, in 500 mg capsules, containing the microorganisms Lacticaseibacillus paracasei subsp. Paracasei and Bifidobacterium lactis (animals) at a dose of 3×109 CFU/g of each strain (supplied by Hansen Company), daily from recruitment (22- 26 weeks) until six weeks after delivery. Intervention 2: Control group: Women in the control group will receive starch-containing placebo , in 500 mg capsules, daily from recruitment (22- 26 weeks) until six weeks after delivery. Yes - There is a plan to make this available What will be shared: The requested data will be provided to researchers for statistical analysis (meta-analysis) of the submitted proposals. When: Starting immediately after the publication of the study results To whom: Data will be available to researchers working at academic organizations, as well as to the chief editor (and reviewers) of the journal of the submitted manuscript/s if requested. Conditions: The data will be available to researchers upon request and submission of a proposal to perform a meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to the journal of the submitted manuscript/s for checking the accuracy of the data. Where to obtain: Refer to the email address (alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com) How to obtain: The requests will be sent by email and data will be available within a week. Comments:
public Maryam Alikamali
Nursing & Midwifery Faculty, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 59691-15868 +98 42 3342 3494 m_kamali1984@yahoo.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6969 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 17 years 45 years Female 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 O60 F32.8 Preterm labor Other depressive episodes Prevention Prevention Women in the intervention group will receive probiotic supplements, in 500 mg capsules, containing the microorganisms Lacticaseibacillus paracasei subsp. Paracasei and Bifidobacterium lactis (animals) at a dose of 3×109 CFU/g of each strain (supplied by Hansen Company), daily from recruitment (22- 26 weeks) until six weeks after delivery. Control group: Women in the control group will receive starch-containing placebo , in 500 mg capsules, daily from recruitment (22- 26 weeks) until six weeks after delivery. 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. 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 recommended one. Anxiety. Timepoint: At baseline, one month of the intervention, 40-45 days after delivery. Method of measurement: Using the Beck Anxiety Scale. Occurrence of mastitis in the woman. Timepoint: 40-45 days after birth. Method of measurement: Using the mastitis scale. Tabriz University of Medical Sciences Approved 2022-10-30 Ethics Committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)