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Effect of oral probiotics on the prevention of preterm delivery

Evaluation of the effect of oral probiotics on the prevention of preterm delivery in mothers at risk of preterm delivery compared with placebo

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201108049300N1
Enrollment
120
Registered
2021-10-02
Start date
2021-09-18
Completion date
Unknown
Last updated
2021-11-01

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

Conditions

preterm delivery. Preterm labor with preterm delivery

Interventions

Intervention 1: Intervention group: Lactofem capsule (500 mg) made by Iranian zist-takhmir Company will be administered orally and daily from the 16 weeks until the end of pregnancy. Intervention 2: C

Sponsors

Yasouj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patient age 18-45 years Gestational age between 16-24 weeks Absence of syphilis, gonorrhea and HIV clinically Having risk factors for preterm delivery in the current pregnancy, including a history of preterm delivery or a second trimester abortion in a previous pregnancy No elective or emergency cerclage Lack of maternal insulin-dependent diabetes mellitus, treatment of hypertension, lupus

Exclusion criteria

Exclusion criteria: Reluctance to participate in the study Failure to complete the course of treatment or use of probiotics Taking drugs that affect the intestinal microbial flora, such as antibiotics Occurrence of any genital or urinary tract infection requires antibiotic treatment during treatment Fetus with congenital malformations and abnormal scan anomalies Clinical chorioamnionitis

Design outcomes

Primary

MeasureTime frame
Premature preterm birth (less than 34 weeks gestation). Timepoint: End of intervention. Method of measurement: Symptom.;Late preterm birth (34-37 weeks gestation). Timepoint: End of intervention. Method of measurement: Symptom.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRaziyeh Vanda

Yasouj University of Medical Sciences

ra.vanda@yahoo.com+98 74 3333 7251

Outcome results

None listed

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