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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dra.Cristina Martinez Payo, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT01643980
First received: June 12, 2012
Last updated: October 14, 2016
Last verified: October 2016
  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 randomization until delivery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of spontaneous preterm birth before 37 weeks of gestation [ Time Frame: up to 17 weeks (from date of randomization until delivery) ] [ Designated as safety issue: No ]
  • Proportion of Spontaneous preterm birth before 28 weeks of gestation [ Time Frame: up to 8 weeks (from date of randomization 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 randomization until delivery) ] [ Designated as safety issue: No ]
  • Weight at birth [ Time Frame: up to 21 weeks (from date of randomization until delivery) ] [ Designated as safety issue: No ]
  • Rate of fetal and neonatal mortality [ Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks ] [ Designated as safety issue: No ]
  • Symptomatic vaginal infections during treatment period [ Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with adverse events [ Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks ] [ Designated as safety issue: Yes ]
  • Rate of Chorioamnionitis during third term [ Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks ] [ Designated as safety issue: No ]
  • Need of admission because of premature labor before 34 weeks of gestation [ Time Frame: up to 14 weeks (from date of randomization until delivery) ] [ Designated as safety issue: No ]
  • Rate of neonatal morbidity [ Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: August 2012
Study Completion Date: April 2016
Primary Completion Date: March 2016 (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   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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

Locations
Spain
University Hospital San Juan de Alicante
Sant Joan d'Alacant, Alicante, Spain, 03550
Igualada Hospital
Igualada, Barcelona, Spain, 08700
University Hospital Príncipe de Asturias
Alcalá de Henarés, Madrid, Spain, 28805
University Hospital Fundación de Alcorcón
Alcorcón, Madrid, Spain, 28922
University Hospital Madrid Monte Principe
Boadilla del Monte, Madrid, Spain, 28660
University Hospital Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
University Hospital de Getafe
Getafe, Madrid, Spain, 28905
University Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
University Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
University Hospital Rey Juan Carlos I
Mostoles, Madrid, Spain, 28933
University Hospital Mostoles
Móstoles, Madrid, Spain, 28935
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain, 28702
Hospital Infanta Elena
Valdemoro, Madrid, Spain, 28040
Palamos Hospital
Gerona, Palamos, Spain, 17320
Hospital Universitario de Donostia
Donostia, San Sebastian, Spain, 20080
University Hospital Quiron Dexeus
Barcelona, Spain, 08028
Burgos University Hospital
Burgos, Spain, 09006
Ciudad Real General University Hospital
Ciudad Real, Spain, 13005
Guadalajara General University Hospital
Guadalajara, Spain, 19002
University Hospital de León
León, Spain, 24071
Sanitas La Zarzuela Hospital
Madrid, Spain, 28023
University Hospital Ramón y Cajal
Madrid, Spain, 28046
Sanitas La Moraleja Hospital
Madrid, Spain, 28050
University Hospital Quirón Málaga
Málaga, Spain, 29004
Valladolid Clinic Universitary Hospital
Valladolid, Spain, 47005
University Hospital Rio Hortega
Valladolid, Spain, 47012
University Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Dra.Cristina Martinez Payo
Investigators
Principal Investigator: Sara Cruz Melguizo, Dr University Hospital Puerta de Hierro Majadahonda
Principal Investigator: Cristina Martinez Payo, Dr. University Hospital Puerta de Hierro Majadahonda
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dra.Cristina Martinez 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: October 14, 2016
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on December 06, 2016