Clinical trial NCT00646802: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Threatened Premature Labor
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Proportion of deliveries before week 34 of gestation
timeFrame: week 34 of gestation
Secondary outcomes:
measure: Median time from randomization to delivery
timeFrame: delivery
measure: Ultrasound cervical length
timeFrame: week +5
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Hospital Sant joan de Déu de Manresa
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital de Terrassa. CST
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno Infantil
state: Gran Canaria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Islas Baleares
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Madrid
country: Spain
facility: Hospital U Gregorio Marañon
city: Seville
country: Spain
facility: Hospital Virgen de la Macarena
city: Zaragoza
country: Spain
facility: Hospital Clinico U. Lozano Blesa
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Montse Palacio, MD
role: PRINCIPAL_INVESTIGATOR
References: