Vaginal progesterone plus cervical pessary for preventing preterm birth
Not Applicable
- Conditions
- Preterm delivery.Preterm spontaneous labour with preterm delivery
- Registration Number
- IRCT201603109568N15
- Lead Sponsor
- Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 144
Inclusion Criteria
18-40 years of age; singleton gestation; 18-22 gestational weeks; cervical length of less than 25 millimeters by transvaginal ultrasound; no cervical dilation; no history of any medical illness.
Exclusion criteria: : any medical illness upon enrollment; having urogenital infection; major fetal abnormalities; painful regular uterine contractions; placenta previa; ruptured membranes; active vaginal bleeding; history of cone biopsy; refusing to provide informed consent to participate in the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preterm birth before 37 weeks of gestation. Timepoint: monthly, after the intervention, untill 37th week of gestational. Method of measurement: clinical delivery and the time is assessed based on ultrasound imaging.
- Secondary Outcome Measures
Name Time Method ow birth weight (LBW) delivery. Timepoint: After birth. Method of measurement: weighing scale.;Premature rupture of membranes. Timepoint: after the intervention. Method of measurement: clinical examination.;Chorioamnionitis. Timepoint: after the intervention. Method of measurement: diagnosed based on placental pathology after delivery.;Requirement for NICU admission. Timepoint: after the intervention. Method of measurement: clinical examination.;Fetal or neonatal death rate. Timepoint: after the intervention. Method of measurement: clinical examination.