comparison of oral Dydrogesterone and 17a Hydroxyprogesterone Caproate in prevention of preterm birth in patients with preterm labor
Phase 3
Recruiting
- Conditions
- preterm labor.Preterm labor without delivery
- Registration Number
- IRCT20181207041879N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
age between 18 to 35 years old
gestational age between 28 to 34 weeks (calculated based on first trimester ultrasound)
no recurrence of preterm labor symptoms 48 hours after treatment
singleton pregnancy
no use of tobacco
symptoms of preterm labor
Exclusion Criteria
Placenta Previa
preterm premature rupture of membranes (PROM)
Chorioamnionitis
severe preeclampsia
use of progesterone before entering the study
contraindications to use of progesterone
contraindications to Tocolysis
dilation of more than 4 cm
fetal anomaly
uterine scar
cervical cerclage
uterine anomaly
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gestational age at the time of birth. Timepoint: At the time of birth. Method of measurement: Calculation of gestational age.;Apgar score at first and fifth minute. Timepoint: After child birth. Method of measurement: clinical observation.;Birth weight. Timepoint: time of birth. Method of measurement: Using the scales.;Stillbirth. Timepoint: at the time of birth. Method of measurement: clinical observation.;Fetal weight percentiles at the time of birth based on gestational age. Timepoint: at the time of birth. Method of measurement: using scales and tape measure.
- Secondary Outcome Measures
Name Time Method