MedTrace Logo

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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Threaten Preterm
  • Prethrem Labour
  • Bacterial Vaginitis

Interventions

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.

Sponsors & Collaborators

  • Queen Savang Vadhana Memorial Hospital, Thailand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-07-31
Completion
2026-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344064 on ClinicalTrials.gov