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

ConditionsThreaten Preterm Prethrem Labour Bacterial Vaginitis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-35

SponsorQueen Savang Vadhana Memorial Hospital, Thailand

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Gynoflor
Drug
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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: gynoflor groupExperimental treatment 1 intervention

Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

proportion of women remaining pregnant more than 7 days after initiation of tocolytic

Time frame

within 7 days from the start of tocolytic

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Savang Vadhana Memorial Hospital, Thailand

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: