Status:
COMPLETED
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Threatened Premature Labor
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman ac...
Eligibility Criteria
Inclusion
- Pregnant women aged between 18 - 45 years
- Gestational age between 24.0 and before 33.6 gestational weeks
- Singleton pregnancy
- Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
- Ultrasound cervical length at discharge \< 25 mm
- Signed patient consent form (CI)
Exclusion
- Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
- Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
- With known allergy to progesterone or peanuts (excipient).
- Grade 2 (or upper) renal or liver laboratory abnormalities
- Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
- With Diabetes mellitus or insulinized gestational diabetes
- Treated with heparin
- Drug abuse
- Inadequate treatment compliance
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00646802
Start Date
June 1 2008
End Date
May 1 2012
Last Update
August 19 2016
Active Locations (12)
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1
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain, 07198
2
Institut Universitari Dexeus
Barcelona, Barcelona, Spain, 08028
3
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036
4
Hospital Sant joan de Déu de Manresa
Manresa, Barcelona, Spain, 08243