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A Randomized Controlled Trial Comparing the Efiicacy of Oral Micronized Progesterone at 200 Miligrams per Day Versus 600 Miligrams per Day for Tocolytic Effect Maintenance in Preterm Labor

A Randomized Controlled Trial Comparing the Efiicacy of Oral Micronized Progesterone at 200 Miligrams per Day Versus 600 Miligrams per Day for Tocolytic Effect Maintenance in Preterm Labor

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241028003
Enrollment
98
Registered
2024-10-28
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

There are no standard recommendations for maintaining the effects of tocolytics. This is the first study to compare dosage of progesterone in the aspected of maintanance tocolytic effects. Hopefully, The result of this study may increase precentage of the term birth and improved neonatal outcome. - oral micronized progesterone. - preterm birth - neonatal outcome

Interventions

200 mg per day of oral micronize progesterone, prescribe after complete acute tocolytic effect 48 hours until 36 week of gestation,600 mg per day of oral micronize progesterone, prescribe after comple
Experimental Drug,Active Comparator Drug
200 mg per day of oral micronize progesterone,600 mg per day of oral micronize progesterone

Sponsors

Thai Red Cross Society
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Low risk with singleton pregnancy 2.Presented with preterm labor and responded to acute tocolysis treatment 3.Gestational age of 24 to 33+6 weeks 4.Cervical dilation less than 3 cm at the time of recruitment

Exclusion criteria

Exclusion criteria: 1.Have contraindication and inability to tolerate the side effects of micronized progesterone 2.Have risk factors for preterm labor (e.g., previous preterm birth, prior LEEP, polyhydramnios, bacterial vaginosis) 3.Progression to the active phase of labor or presence of ruptured membranes 4.Requirement for any tocolytic drugs after recruitment

Design outcomes

Primary

MeasureTime frame
Precent of term birth and the number of day prolongation period at the day of delivery record

Secondary

MeasureTime frame
Neonatal outcome (BBW, Apgar score, NICU admission) at the day of delivery record,Side effect of oral micronized progesterone every visit record

Countries

Thailand

Contacts

Public ContactPitchaya Hotravareekarnjana

Thai red cross society

pitchaya9861@gmai.com0879039861

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026