Adjunctive Vaginal Progesterone in Management of Preterm Labor

Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05997563

Enrollment

Registered

2023-08-18

Start date

2023-08-16

Completion date

2025-10-31

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

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.

Interventions

DRUGMicronized progesterone

Vaginal micronized progesterone effervescent once daily until delivery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
latency period	13 weeks	time from preterm labor to delivery

Secondary

Measure	Time frame	Description
preterm delivery less than 34 weeks	10 weeks	percentage of preterm delivery less than 34 weeks
preterm delivery less than 37 weeks	13 weeks	percentage of preterm delivery less than 37 weeks
neonatal complications	13 weeks	percentage of newborn with RDS, IVH, NEC, death
side effects	13 weeks	percentage of side effects such as headache, nausea/vomiting
gestational age at delivery	13 weeks	mean gestational age at delivery
good satisfaction	13 weeks	percentage of good satisfaction
good quality of life	13 weeks	percentage of good quality of life
Time to the recurrence of uterine contractions	13 weeks	mean time to the recurrence of uterine contractions
compliance	13 weeks	percentage of complete drug use

Countries

Thailand

Contacts

Primary ContactVorapong Phupong, M.D.

vorapong.p@chula.ac.th+66816339296

Backup ContactJirapat Chanratchakool, M.D.

sunnjc.jc@gmail.com+66819322352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026