preterm birth. Preterm spontaneous labour with preterm delivery
Conditions
Interventions
Intervention 1: Control group:
participants will receive 400mg Cyclogest vaginal suppositories once daily, starting from the 16th gestational week until 37th week. Intervention 2: Intervention group:
Treatment - Drugs
Control group:
participants will receive 400mg Cyclogest vaginal suppositories once daily, starting from the 16th gestational week until 37th week.
Intervention group:
will receive weekly intramuscular injections of 250mg of 17-Hydroxyprogesterone Caproate (17-HPC), starting from the 16th to the 37th weeks of pregnancy.
Sponsors
Maternal Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 20–40 years of age; having a singleton pregnancy; a gestational age of 16-17 weeks; a positive history for preterm labor. Exclusion criteria: positive history for thromboembolic events; cardiovascular disorders; diabetes; hepatic disorders; breast or genital neoplastic disorders; vaginal bleeding; missed abortion; and hypersensitivity to progesterone.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychiatric disorders. Timepoint: Two months after intervention. Method of measurement: The 28- General Health Questionnaire (GHQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile. Timepoint: 2 months after intervention. Method of measurement: Blood sample.;Blood glucose. Timepoint: 2 months after intervention. Method of measurement: Blood sample.;Preterm birth. Timepoint: After intervention. Method of measurement: Clinical birth. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mahdi Sheikh
Maternal Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Outcome results
None listed