Clinical trial NCT05997563: Adjunctive Vaginal Progesterone in Management of Preterm Labor
Official title: Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Preterm Labor
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy with gestational age 24-33 weeks 6 days
* preterm labor
* received treatment with tocolysis and corticosteroids

Exclusion Criteria:

* conditions that need immediate delivery such as fetal distress, chorioamnionitis
* have medical complications such as heart disease, seizure
* fetal anomalies
* cervical dilatation more than 5 cm
* allergy to progesterone
* contraindication to progesterone
* contraindication to tocolytic use

Primary outcomes:
measure: latency period
timeFrame: 13 weeks
Secondary outcomes:
measure: gestational age at delivery
timeFrame: 13 weeks
measure: preterm delivery less than 34 weeks
timeFrame: 10 weeks
measure: preterm delivery less than 37 weeks
timeFrame: 13 weeks
measure: neonatal complications
timeFrame: 13 weeks
measure: side effects
timeFrame: 13 weeks
measure: compliance
timeFrame: 13 weeks
measure: good satisfaction
timeFrame: 13 weeks
measure: good quality of life
timeFrame: 13 weeks
measure: Time to the recurrence of uterine contractions
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Vorapong Phupong
Study officials:
affiliation: Chulalongkorn University
name: Vorapong Phupong, M.D.
role: STUDY_DIRECTOR
References:
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