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Efficacy of Vaginal Progesterone for Maintenance Therapy in Arrested Preterm Labor: A Randomized Controlled Trial

Phase 3
Completed
Conditions
preterm labor at gestational age of 24 weeks to 33 weeks and 6 dayssuccessfully inhibited with Nifedipine as an acute phase tocolysis (arrested preterm labor)
Preterm labor
Registration Number
TCTR20230901006
Lead Sponsor
Hatyai hospital
Brief Summary

High-dose vaginal progesterone, as a maintenance agent, efficiently prolongs latency delivery day, reduces the rate of preterm birth and improves birth weight. However, it fails to delay the shortening of the cervix and does not decrease the rate of NICU admission.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
80
Inclusion Criteria

Pregnant women presented with preterm labor at gestational age of 24 completed weeks to 33 weeks and 6 days

Exclusion Criteria

lethal fetal anomaly
dead fetus in utero
non-reassuring fetal status
preeclampsia with severe features
unstable maternal vital signs
chorioamnionitis
patient allergic to progesterone or progestrogen
multifetal gestations
placenta previa
cervical os open more than 4 cm
history of cervical cerclage in this pregnancy
history of vaginal progesterone used in this pregnancy due to others indication for example ; short cervix

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
atency days from the day presented with preterm labor to the day of delivery Unpaired student T-test
Secondary Outcome Measures
NameTimeMethod
Gestational age at delivery Days,Birth asphyxia 1, 5 minutes after birth Apgar score,NICU admission after delivery Yes or no,Low birthweight at delivery Grams
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