Threaten PretermNCT07344064
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
A study testing Gynoflor in people with Threaten Preterm and Prethrem Labour, run by Queen Savang Vadhana Memorial Hospital, Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Threaten Preterm, Prethrem Labour, Bacterial Vaginitis
- What is being tested?
- Gynoflor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women diagnosed with preterm labor or threatened preterm labor, with a gestational age between 24 and 33 weeks, who are receiving tocolytic therapy.
Who cannot join
- 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®
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- 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
About this study
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.
Read the 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:
- Gestational age at delivery ≥34 weeks
- Length of hospital stay (in days)
- Use of second-line tocolytic agents (e.g., switching due to inefficacy or side effects)
- Readmission within 14 days after discharge
- Incidence of side effects from Gynoflor® (especially local symptoms like vaginal burning or irritation)
- Conditions
- Threaten Preterm, Prethrem Labour, Bacterial Vaginitis
- Being tested
- Gynoflor
- Keywords
- Lactobacillus, Gynoflor, Threaten preterm, Bacterial vaginitis, Probiotic
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GynoflorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| gynoflor group | Experimental | Not described Receives: Drug: Gynoflor |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of women remaining pregnant more than 7 days after initiation of tocolytic
Measured: within 7 days from the start of tocolytic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threaten PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344064
- Sponsor's protocol ID
- 015/2568
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07344064
- Acronym / sponsor ID
- 015/2568
- Conditions
- Threaten Preterm, Prethrem Labour, Bacterial Vaginitis
- Keywords
- Lactobacillus, Gynoflor, Threaten preterm, Bacterial vaginitis, Probiotic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Gestational age at delivery ≥34 weeks
- Length of hospital stay (in days)
- Use of second-line tocolytic agents (e.g., switching due to inefficacy or side effects)
- Readmission within 14 days after discharge
- Incidence of side effects from Gynoflor® (especially local symptoms like vaginal burning or irritation)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gynoflor group | Experimental | Drug: Gynoflor |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women diagnosed with preterm labor or threatened preterm labor, with a gestational age between 24 and 33 weeks, who are receiving tocolytic therapy.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GynoflorParticipants 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. | Drug | gynoflor group |
Primary outcome
proportion of women remaining pregnant more than 7 days after initiation of tocolytic
Time frame: within 7 days from the start of tocolytic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gynoflor in people with Threaten Preterm and Prethrem Labour, run by Queen Savang Vadhana Memorial Hospital, Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of women remaining pregnant more than 7 days after initiation of tocolytic (time frame: within 7 days from the start of tocolytic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.