drugset / Trial / NCT07344064

The Effects of Adjunctive Therapy With Vaginal Tablets Lactobacillus Acidophilus and a Low Dose Estriol (Gynoflor®) to Prolong Pregnancy Time in Preterm Labor, A Randomized Controlled Trial

NCT07344064

Not yet recruiting 80 enrolled Queen Savang Vadhana Memorial Hospital, Thailand
RandomizedParallel-groupOpen-labelTreatment

Summary

The study aim to study The Adjunctive therapy with vaginal tablets containing Lactobacillus acidophilus KS400 and low-dose Estriol (Gynoflor®) in addition to standard tocolytic treatment administered once daily for 6 days starting the same day as tocolytic therapy, in pregnant women diagnosed with preterm labor at gestational age 24-33 weeks .Primary Outcome is the rate of pregnancy prolongation beyond 7 days after initiation of tocolytic therapy.

Timeline

Start
2026-02
Primary completion
2026-07
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Estriol Unknown 0.03 mg Other
Subject Lactobacillus acidophilus KS400 Unknown Other

Indications