Early Onset of Delivery Before 37 Weeks Clinical Trial
— PESAPROOfficial title:
Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies
| Verified date | October 2016 |
| Source | Puerta de Hierro University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Spanish Agency of Medicines |
| Study type | Interventional |
The preterm birth is considered as a main problem in the modern obstetrics, being the
responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the
significant medical advances, the rate of prematurity has not declined over the past 40
years and even continues to rise in the developed countries. In order to decrease the
prematurity is necessary that two premises: to identify the pregnant women at risk of
preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and
therefore avoid preterm delivery. The investigators propose a clinical trial with the
objective to identify effective strategies to reduce the premature birth (34 weeks and
earlier) rate in the population of pregnant women at risk for premature birth, which will be
identified by ultrasound during the second trimester of their pregnancy.
The investigators intend to compare two accepted strategies: administration of progesterone
(vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy
to apply, and they present very few maternal-fetal secondary effects.
| Status | Completed |
| Enrollment | 254 |
| Est. completion date | April 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Pregnant women with short cervix (=< 25 mm) identified by use of routine transvaginal ultrasonography at 19-22 weeks of gestation. - Single pregnancy - Women older than 18 year-old - Women sign informed consent according GCP and local legislation - Gestational age at randomization between 20+1 and 23+6 weeks. Exclusion Criteria: - Major fetal abnormalities - Major uterine abnormalities - Placenta praevia during current pregnancy - Vaginal bleeding or ruptured membranes in the moment of randomization - Cervical cerclage in situ - History of cone biopsy - Allergic to peanuts - Contraindication for Progesterone usage. - Active treatment with Progesterone at randomization. - History of 3 or more premature labor. - If in the investigator's opinion, there are findings on physical examination, abnormalities in the results of clinical analyzes or other medical factors, social or psycho-social that could negatively influence. - Women unable to give the informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | University Hospital Príncipe de Asturias | Alcalá de Henarés | Madrid |
| Spain | University Hospital Fundación de Alcorcón | Alcorcón | Madrid |
| Spain | University Hospital Quiron Dexeus | Barcelona | |
| Spain | University Hospital Madrid Monte Principe | Boadilla del Monte | Madrid |
| Spain | Burgos University Hospital | Burgos | |
| Spain | Ciudad Real General University Hospital | Ciudad Real | |
| Spain | Hospital Universitario de Donostia | Donostia | San Sebastian |
| Spain | University Hospital Fuenlabrada | Fuenlabrada | Madrid |
| Spain | Palamos Hospital | Gerona | Palamos |
| Spain | University Hospital de Getafe | Getafe | Madrid |
| Spain | Guadalajara General University Hospital | Guadalajara | |
| Spain | Igualada Hospital | Igualada | Barcelona |
| Spain | University Hospital Severo Ochoa | Leganés | Madrid |
| Spain | University Hospital de León | León | |
| Spain | Sanitas La Moraleja Hospital | Madrid | |
| Spain | Sanitas La Zarzuela Hospital | Madrid | |
| Spain | University Hospital Ramón y Cajal | Madrid | |
| Spain | University Hospital Puerta de Hierro | Majadahonda | Madrid |
| Spain | University Hospital Quirón Málaga | Málaga | |
| Spain | University Hospital Rey Juan Carlos I | Mostoles | Madrid |
| Spain | University Hospital Mostoles | Móstoles | Madrid |
| Spain | Hospital Infanta Sofía | San Sebastián de los Reyes | Madrid |
| Spain | University Hospital San Juan de Alicante | Sant Joan d'Alacant | Alicante |
| Spain | Hospital Infanta Elena | Valdemoro | Madrid |
| Spain | University Hospital Rio Hortega | Valladolid | |
| Spain | Valladolid Clinic Universitary Hospital | Valladolid | |
| Spain | University Hospital Miguel Servet | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Dra.Cristina Martinez Payo |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of spontaneous preterm birth before 34 weeks of gestation | up to 11 weeks (from date of randomization until delivery) | No | |
| Secondary | Proportion of spontaneous preterm birth before 37 weeks of gestation | up to 17 weeks (from date of randomization until delivery) | No | |
| Secondary | Proportion of Spontaneous preterm birth before 28 weeks of gestation | up to 8 weeks (from date of randomization until delivery) | No | |
| Secondary | Rate of premature rupture of membranes before 34 weeks of gestation | up to 11 weeks (from date of randomization until delivery) | No | |
| Secondary | Weight at birth | up to 21 weeks (from date of randomization until delivery) | No | |
| Secondary | Rate of fetal and neonatal mortality | From date of randomization until the date of delivery, assessed up 21 weeks | No | |
| Secondary | Symptomatic vaginal infections during treatment period | From date of randomization until the date of delivery, assessed up 21 weeks | No | |
| Secondary | Proportion of participants with adverse events | From date of randomization until the date of delivery, assessed up 21 weeks | Yes | |
| Secondary | Rate of Chorioamnionitis during third term | From date of randomization until the date of delivery, assessed up 21 weeks | No | |
| Secondary | Need of admission because of premature labor before 34 weeks of gestation | up to 14 weeks (from date of randomization until delivery) | No | |
| Secondary | Rate of neonatal morbidity | From date of randomization until the date of delivery, assessed up 21 weeks | No |