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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Vaginitis; Threaten Preterm; Prethrem Labour
• Intervention / Treatment: Drug: Gynoflor

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)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

- Pregnant women diagnosed with preterm labor or threatened preterm labor, with a gestational age between 24 and 33 weeks, who are receiving tocolytic therapy.

Exclusion Criteria

• Age under 18 years or 35 years and older
• Incomplete course of Gynoflor® (less than 6 days of use)
• Presence of contraindications to tocolysis
• Preterm premature rupture of membranes (PPROM)
• Unable to be contacted for follow-up
• History of allergy to probiotics or Gynoflor®
• Multiple gestation
• History of short cervix diagnosed between 16-24 weeks of gestation
• History of previous preterm labor (PTL)
• Pregnancy achieved via assisted reproductive technology (ART)
• Presence of fetal anomaly
• History of antepartum hemorrhage
• Substance abuse, including cigarette smoking, alcohol, cocaine, or heroin use
• Other causes of preterm labor such as uterine overdistension (e.g., polyhydramnios, multifetal gestation), uterine abnormalities (e.g., myoma uteri), or systemic infections, except vaginitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: gynoflor group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of women remaining pregnant more than 7 days after initiation of tocolytic	within 7 days from the start of tocolytic

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Probiotic; Lactobacillus; Gynoflor; Threaten preterm; Bacterial vaginitis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: 015/2568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No