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 DMC

• 1 other identifier: 015/2568
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Lactobacillus; Gynoflor; Threaten preterm; Bacterial vaginitis; Probiotic

Outcome Measures

Primary Outcomes (1)

• proportion of women remaining pregnant more than 7 days after initiation of tocolytic

  within 7 days from the start of tocolytic

Study Arms (2)

gynoflor group

EXPERIMENTAL

Drug: Gynoflor

control group

NO INTERVENTION

Interventions

Gynoflor DRUG

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.

gynoflor group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share