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

Official Title: “Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial”

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.

Intervention(s) in this Clinical Trial

• Drug: Progesterone
  • 1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
• Drug: Placebo
  • 1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Progesterone 200 mg
• Placebo Comparator: B
  • Placebo

Primary Measures

• Proportion of deliveries before week 34 of gestation
  • Time Frame: week 34 of gestation
    Safety Issue?: No

Secondary Measures

• Median time from randomization to delivery
  • Time Frame: delivery
    Safety Issue?: No
• Ultrasound cervical length
  • Time Frame: week +5
    Safety Issue?: No

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 with 48 h of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
• Ultrasound cervical length at discharge < 25 mm
• Signed patient consent form (CI)

Exclusion Criteria:

• Previous admittance to the hospital due to preterm labor that required tocolytic drugs in the current pregnancy
• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Hospital Clinic of Barcelona Other

Overall Clinical Trial Officials and Contacts

Montse Palacio, MD Principal Investigator Hospital Clinic Barcelona  

Overall Contact: Montse Palacio, MD  mpalacio@clinic.ub.es

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00646802

Study ID Number: PROMISE

ClinicalTrials.gov Identifier: NCT00646802

Health Authority: Spain: Spanish Agency of Medicines