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

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Not yet enrolling

Conditions: Threaten Preterm; Bacterial Vaginitis; Prethrem Labour

Treatments: Drug: Gynoflor

Study type: Interventional

Funder types: Other

Identifiers

NCT07344064

015/2568

Details and patient eligibility

About

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.

Full 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)

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

gynoflor group

Experimental group

Treatment:

Drug: Gynoflor

control group

No Intervention group