Effect of probiotic administration to women at risk of preterm birth on some neonatal and maternal outcomes

Phase 3

Conditions: Condition 1: Preterm birth. Condition 2: Postpartum Depression.
Preterm labor
Other depressive episodes
F32.8

Registration Number: IRCT20100414003706N43

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 72

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures