Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies (PESAPRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Puerta de Hierro University Hospital
Sponsor:
Information provided by (Responsible Party):
Dra.Cristina Marti-nez Payo, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT01643980
First received: June 12, 2012
Last updated: May 21, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Early Onset of Delivery Before 37 Weeks
Drug: Vaginal micronized progesterone
Device: Cervical pessary
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies

Resource links provided by NLM:


Further study details as provided by Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • Proportion of spontaneous preterm birth before 34 weeks of gestation [ Time Frame: up to 11 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of spontaneous preterm birth before 37 weeks of gestation [ Time Frame: up to 15 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  • Proportion of Spontaneous preterm birth before 28 weeks of gestation [ Time Frame: up to 5 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  • Rate of premature rupture of membranes before 34 weeks of gestation [ Time Frame: up to 11 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  • Weight at birth [ Time Frame: up to 20 weeks (from date of randomization until delivery) ] [ Designated as safety issue: No ]
  • Rate of fetal intrauterine mortality during treatment period [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: No ]
  • Symptomatic vaginal infections during treatment period [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with adverse events [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: Yes ]
  • Rate of Chorioamnionitis during third term [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal micronized progesterone
200 mg vaginal route per day
Drug: Vaginal micronized progesterone
200 mg vaginal route per day
Active Comparator: Cervical pessary
Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)
Device: Cervical pessary
Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)

Detailed Description:

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. Since 1990, many published articles describe the sonographic measurement of the cervix from the week 16 as method of population screening to detect women at risk. Several studies provide evidence about an inverse relationship between the cervical length and the risk of preterm delivery. For this reason, if there is an effective intervention for patients with cervix short (about < 25mm), made this measure in the middle of the second term, the investigators could reduce the prematurity. Regarding possible therapeutic strategies, recent published data demonstrate the effective of vaginal progesterone and cervical pessary in this population. However, both treatments have never been compared and none of the two strategies are indicated in this population. Therefore it results necessary to compare both treatments in order to establish clinical recommendations. The investigators propose a clinical trial to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries in order 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with short cervix (<de 25mm) 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.

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 peanut
  • Women unable to give the informed consent
  • If in a investigator's opinion, there are findings on physical examination, abnormalities in the results of clinical analyzes or other medical factors, social or psychosocial that could negatively influence.
  • Contraindication for Progesterone usage.
  • Active treatment with Progesterone at randomization.
  • History of 3 or more premature labor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643980

Contacts
Contact: Cristina Martinez Payo, Dr 0034670401817 cmartinezpy@gmail.com
Contact: Sara Cruz Melguizo, Dr 0034659961642 saracruz.gine@yahoo.es

Locations
Spain
University Hospital San Juan de Alicante Recruiting
Sant Joan d'Alacant, Alicante, Spain, 03550
Principal Investigator: Rosa Bermejo         
Sub-Investigator: Isabel Acien         
Sub-Investigator: Faz Cartagena         
Igualada Hospital Recruiting
Igualada, Barcelona, Spain, 08700
Principal Investigator: Joan Carles Mateu         
Sub-Investigator: Nuria Pages         
Sub-Investigator: Isabel Aznar         
Sub-Investigator: Neus Juanmarti         
Sub-Investigator: Gemma Escribano         
Sub-Investigator: Laia Pons         
University Hospital Príncipe de Asturias Recruiting
Alcalá de Henarés, Madrid, Spain, 28805
Principal Investigator: Estefanía Cordero         
Principal Investigator: Pedro Jiménez         
Sub-Investigator: Marta Ontañón         
Sub-Investigator: María Cruz Estevez         
Sub-Investigator: Francisco Martínez Ortega         
Sub-Investigator: Almudena Grassa Garrido         
Sub-Investigator: David Sánchez Nieves         
University Hospital Fundación de Alcorcón Recruiting
Alcorcón, Madrid, Spain, 28922
Principal Investigator: Begoña Adiego         
Sub-Investigator: Ana María González-Spínola         
University Hospital Madrid Monte Principe Recruiting
Boadilla del Monte, Madrid, Spain, 28660
Principal Investigator: Gloria Galvez         
Sub-Investigator: Patricia Calvo         
Sub-Investigator: Nerea Montero         
Sub-Investigator: Monica Novelle         
Sub-Investigator: Maria Alejandra Salvaro         
University Hospital Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28942
Principal Investigator: María Teulón         
University Hospital de Getafe Recruiting
Getafe, Madrid, Spain, 28905
Principal Investigator: Luis Martínez         
University Hospital Severo Ochoa Recruiting
Leganés, Madrid, Spain, 28911
Principal Investigator: Gregoria Alonso         
Sub-Investigator: Ernesto Vizcaíno         
Sub-Investigator: Juan Antonio Fernández         
Sub-Investigator: Begoña Rayado         
Sub-Investigator: Carmen Orizales         
Sub-Investigator: José Antonio Carrillo         
Sub-Investigator: Jesús Romero         
Sub-Investigator: Mª Ángeles Díaz         
Sub-Investigator: Mercedes Artal         
Sub-Investigator: Ana Luis         
University Hospital Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Cristina Martinez Payo, Dr    0034670401817    cmartinezpy@gmail.com   
Contact: Sara Cruz Melguizo, Dr    0034659961642    saracruz.gine@yahoo.es   
Principal Investigator: Cristina Martinez Payo         
Principal Investigator: Sara Cruz Melguizo         
Sub-Investigator: Lourdes Cabrera García         
Sub-Investigator: Francisco López Sánchez         
Sub-Investigator: Luis San Frutos Llorente         
University Hospital Rey Juan Carlos I Recruiting
Mostoles, Madrid, Spain, 28933
Principal Investigator: Rosa Nogales         
Sub-Investigator: Maria Olavarrieta         
Sub-Investigator: Marina Perez         
Sub-Investigator: Laura Muñoz         
Sub-Investigator: Irene Fares         
Sub-Investigator: Ruth Carpintero         
University Hospital Mostoles Recruiting
Móstoles, Madrid, Spain, 28935
Principal Investigator: Emilia de Dios         
Hospital Infanta Sofía Recruiting
San Sebastián de los Reyes, Madrid, Spain, 28702
Principal Investigator: José Alberto Rodríguez         
Hospital Infanta Elena Recruiting
Valdemoro, Madrid, Spain, 28040
Principal Investigator: Esther Pérez         
Palamos Hospital Active, not recruiting
Gerona, Palamos, Spain, 17320
Hospital Universitario de Donostia Recruiting
Donostia, San Sebastian, Spain, 20080
Principal Investigator: Arantza Lekuona         
Sub-Investigator: Ana Alberro         
Sub-Investigator: Juan Mª Landa         
Sub-Investigator: Mª Jose Larraza         
University Hospital Quiron Dexeus Recruiting
Barcelona, Spain, 08028
Principal Investigator: Alberto Rodriguez         
Sub-Investigator: Ahinoa Cobo         
Sub-Investigator: Eva Meler         
Sub-Investigator: Sonia Rombaut         
University Hospital General Yagüe Recruiting
Burgos, Spain, 09006
Principal Investigator: Javier Martínez         
Sub-Investigator: Adrián Martín García         
Sub-Investigator: Mª Angeles Martín Macías         
Sub-Investigator: Henar Crespo         
Sub-Investigator: Asunción Fernández Pérez         
Sub-Investigator: Verónica Palomo Cabañes         
Ciudad Real General University Hospital Recruiting
Ciudad Real, Spain, 13005
Principal Investigator: MªAngeles Anaya         
Sub-Investigator: Lourdes Sanchez         
Sub-Investigator: Salvador Sedeño         
Sub-Investigator: Javier Haya         
Sub-Investigator: Antonio Sánchez         
University Hospital Reina Sofia Active, not recruiting
Córdoba, Spain, 14004
Guadalajara General University Hospital Recruiting
Guadalajara, Spain, 19002
Principal Investigator: Maria Jesus Cancelo         
Sub-Investigator: Ana Zamora         
Sub-Investigator: Mª Jesus Camara         
Sub-Investigator: Jose Luis Abollado         
Sub-Investigator: Laura Yago         
Sub-Investigator: María Martin         
Sub-Investigator: Sonia Garcia         
Sub-Investigator: Teresa Martinez         
University Hospital de León Recruiting
León, Spain, 24071
Principal Investigator: Celso García         
Sanitas La Moraleja Hospital Recruiting
Madrid, Spain, 28050
Principal Investigator: Eduardo Cabrillo         
Sub-Investigator: María Terán         
Sub-Investigator: Javier Pérez         
Sanitas La Zarzuela Hospital Recruiting
Madrid, Spain, 28023
Principal Investigator: Elisa Maria Diaz de Teran         
Sub-Investigator: Ana Isabel Prieto         
Sub-Investigator: Margarita Ruiz         
Sub-Investigator: Maria Fasero         
Sub-Investigator: Ignacio Cristobal         
University Hospital La Paz Active, not recruiting
Madrid, Spain, 28046
University Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28046
Principal Investigator: Leopoldo Abarca         
Sub-Investigator: Irene Pelayo Delgado         
Sub-Investigator: Jesus Lázaro De la Fuente         
University Hospital Quirón Málaga Recruiting
Málaga, Spain, 29004
Principal Investigator: Daniel Abehsera         
Sub-Investigator: Marta Garcia         
Sub-Investigator: Rosa Lopez         
University Hospital Marques de Valdecilla Withdrawn
Santander, Spain, 39008
University Hospital Rio Hortega Recruiting
Valladolid, Spain, 47012
Principal Investigator: Gonzalo Enrique Quesada         
Sub-Investigator: Alicia Benavente Berzosa         
Sub-Investigator: Ruth Bernerdo Vega         
Sub-Investigator: Angel Martínez Martín         
Sub-Investigator: Jose Manuel Mayor González         
Sub-Investigator: Ana Román de la Peña         
Valladolid Clinic Universitary Hospital Recruiting
Valladolid, Spain, 47005
Principal Investigator: Cristina Alvarez         
Sub-Investigator: Dominica Nieto         
Sub-Investigator: Henar Crespo         
Sub-Investigator: Javier Cortejoso         
Sub-Investigator: Jose Ignacio Gonzalez         
Sub-Investigator: Paula Suarez         
Sub-Investigator: Sonia de Miguel         
University Hospital Miguel Servet Recruiting
Zaragoza, Spain, 50009
Principal Investigator: Jose Manuel Campilllos         
Principal Investigator: Ricardo Savirón         
Sub-Investigator: Diego Lerma         
Sub-Investigator: Mª Jesús Franco Royo         
Sub-Investigator: Paola Montañés Bello         
Sub-Investigator: Carlos de Bonrostro         
Sub-Investigator: Pilar Pérez Pérez         
Sub-Investigator: Pilar Garrido Fernández         
Sub-Investigator: Tanit Corbacho         
Sub-Investigator: Elena De Diego Allue         
Sub-Investigator: Marta Palacios Lázaro         
Sub-Investigator: Laura Cotaina Gracia         
Sponsors and Collaborators
Dra.Cristina Marti-nez Payo
Investigators
Principal Investigator: Cristina Martinez Payo, Dr University Hospital Puerta de Hierro Majadahonda
Principal Investigator: Sara Cruz Melguizo, Dr. University Hospital Puerta de Hierro Majadahonda
  More Information

No publications provided

Responsible Party: Dra.Cristina Marti-nez Payo, Principal Investigator, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01643980     History of Changes
Other Study ID Numbers: PESAPRO-2012, 2012-000241-13
Study First Received: June 12, 2012
Last Updated: May 21, 2015
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on July 29, 2015