Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

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 accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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