Bacterial Vaginitis, Prethrem Labour, Threaten Preterm
Conditions
Keywords
Lactobacillus, Gynoflor, Threaten preterm, Bacterial vaginitis, Probiotic
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.
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
DRUGGynoflor
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
Queen Savang Vadhana Memorial Hospital, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of women remaining pregnant more than 7 days after initiation of tocolytic | within 7 days from the start of tocolytic |
Outcome results
None listed