Threatened Premature Labor Clinical Trial
— PROMISEOfficial title:
Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial
| Verified date | August 2016 |
| Source | Hospital Clinic of Barcelona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Spanish Agency of Medicines |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 265 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 (ß-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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Institut Universitari Dexeus | Barcelona | |
| Spain | Hospital de Basurto | Bilbao | |
| Spain | Hospital Puerta del Mar | Cádiz | |
| Spain | Complejo Hospitalario Universitario Insular-Materno Infantil | Las Palmas de Gran Canaria | Gran Canaria |
| Spain | Hospital U Gregorio Marañon | Madrid | |
| Spain | Hospital Sant joan de Déu de Manresa | Manresa | Barcelona |
| Spain | Hospital Son Llàtzer | Palma de Mallorca | Islas Baleares |
| Spain | Corporació Sanitària Parc Taulí | Sabadell | Barcelona |
| Spain | Hospital Virgen de la Macarena | Seville | |
| Spain | Hospital de Terrassa. CST | Terrassa | Barcelona |
| Spain | Hospital Clinico U. Lozano Blesa | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Clinic of Barcelona |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of deliveries before week 34 of gestation | week 34 of gestation | No | |
| Secondary | Median time from randomization to delivery | delivery | No | |
| Secondary | Ultrasound cervical length | week +5 | No |