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Effect of proluton and cyclogest on perinatal outcome

Phase 2
Conditions
Preterm birth.
Onset (spontaneous) of labour before 37 completed weeks of gestation
Registration Number
IRCT20181107041585N4
Lead Sponsor
Vice chancellor for research, Hormozgan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
58
Inclusion Criteria

History of more than two previous preterm birth less than 34 weeks
Singleton pregnancy
Cervical length less than 25 mm based on latest vaginal sonography

Exclusion Criteria

Fetal anomaly
Uterine cramp at the time of study
Vaginal bleeding at the time of study
Preterm rupture of membrane
Allergy to hormonal therapy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of preterm birth. Timepoint: After 34 weeks of pregnancy. Method of measurement: Observational.
Secondary Outcome Measures
NameTimeMethod
Gestational age at the time of delivery. Timepoint: At the time of delivery. Method of measurement: Clinical patient record.;Mode of delivery. Timepoint: At the time of delivery. Method of measurement: Clinical patient record.;Newborn weight. Timepoint: Immediately after delivery. Method of measurement: Clinical patient record.;Newborn apgar. Timepoint: Immediately after delivery. Method of measurement: Newborn clinical record.;Incidence of newborn respiratory distress syndrome. Timepoint: At birth and 28 days after birth. Method of measurement: Newborn clinical record.;Incidence of newborn sepsis. Timepoint: At birth and 28 days after birth. Method of measurement: Newborn clinical record.
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