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
Starting soon · Not applicable
Conditions studied: Threaten Preterm, Prethrem Labour, Bacterial Vaginitis
In brief
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.
Key facts
- Study ID
- NCT07344064
- Run by
- Queen Savang Vadhana Memorial Hospital, Thailand
- People needed
- 80
- Starts
- 2026-02-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.
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
Full record on ClinicalTrials.gov
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