None listed
Conditions
Interventions
Drug : - Experimental arm: Self administration of vaginal micronized progesterone 200 mg/day up to either 37 completed weeks of gestation or occurrence of preterm premature rupture of membranes.
- Com
Sponsors
Ewha Womans University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women at age >20 years 2. Women with a history of prior spontaneous preterm birth (PTB) or short cervical length (CL) - Spontaneous PTB: PTB <37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes - Short cervical length(CL): CL <25 mm as measured by transvaginal ultrasound at 15-22 weeks of gestation 3. Women who are at 16-22 weeks of gestation at the point of the first administration of investigational drugs 4. Pregnant women who give informed consent to the study
Exclusion criteria
Exclusion criteria: 1.Multifetal pregnancy 2.Major congenital anomalies diagnosed during antenatal examination 3.Elective prophylactic cervical cerclage <16 weeks of gestation during current pregnancy 4.Dilated cervix 5.Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction 6.Type I or II diabetes mellitus 7.Epilepsy 8.Chronic medical diseases including uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure 110 mmHg at screening), chronic renal disease (serum creatinine level of more than two-folds than upper normal range), and renal failure who needs dialysis 9.History of progesterone therapy within 4 weeks before screening 10.Severe heart diseases, asthma, migraine liver diseases, hepatic tumor, cholestatic jaundice (serum aspartate transaminase, alanine transaminase, bilirubin level of more than more than two-folds than upper normal range) 11.Unknown abnormal uterine bleeding 12.History or suspicious of breast cancer, uterine cancer or other reproductive organ cancer, and history of other cancer during the past 5 years 13.History or suspicious of thrombotic diseases (thrombotic phlebitis, cerebrovascular diseases, pulmonary embolism, retinal thrombosis) 14.History of gestational herpes 15.Porphyria 16.Severe depression 17.Women who need other vaginal treatment 18.Heavy smoker or alcohol abuse 19.Participants of other clinical trial during the past 3 months of screening (non-interventional observational studies are not excluded) 20.Hypersensitivity to progesterone 21.Any other patients who are judged by investigators to be inappropriate for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm birth <37 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Preterm birth <34 weeks of gestation;Preterm birth <28 weeks of gestation;Neonatal outcome;Neonatal complication;Maternal complication;Compliance;Patient's preference;Adverse effects | — |
Countries
Korea, Republic of
Contacts
Public ContactSuk Joo Choi
Samsung Medical Center
Outcome results
None listed