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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants in the intervention group are pregnant women diagnosed with preterm labor between 24 and 33 weeks of gestation. They receive: * Gynoflor® vaginal tablets (containing Lactobacillus acidophilus KS400 and 0.03 mg estriol) * Dosage: 1 tablet inserted vaginally at bedtime for 6 consecutive days * Start time: On the same day as starting standard tocolytic therapy (such as nifedipine, terbutaline, or magnesium sulfate) * Purpose: To restore healthy vaginal flora, reduce risk of ascending infection, and potentially prolong pregnancy duration The control group receives only standard tocolytic therapy, without Gynoflor®. Outcomes (Detailed Description): Primary Outcome: * Rate of pregnancy prolongation beyond 7 days from the initiation of tocolytic therapy Secondary Outcomes: 1. Gestational age at delivery ≥34 weeks 2. Length of hospital stay (in days) 3. Use of second-line tocolytic agents (e.g., switching due to inefficacy or side effects) 4. Readmission within 14 days after discharge 5. Incidence of side effects from Gynoflor® (especially local symptoms like vaginal burning or irritation)

Conditions

• Threaten Preterm
• Prethrem Labour
• Bacterial Vaginitis

Interventions

Type	Name	Description
DRUG	Gynoflor	Participants in this group will receive Gynoflor vaginal tablets (containing Lactobacillus acidophilus and estriol) administered once daily for 7 consecutive days. This intervention aims to evaluate whether restoring vaginal flora with Gynoflor can prolong pregnancy time compared to no intervention.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2026-01-15
• Last updated: 2026-01-15