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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gynoflor.
- Who it may be relevant to
- Registry conditions: Threaten Preterm, Prethrem Labour, Bacterial Vaginitis. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
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.
Primary outcome measures
- proportion of women remaining pregnant more than 7 days after initiation of tocolytic [Time frame: within 7 days from the start of tocolytic]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07344064 · 015/2568