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

NCT01643980 | Completed Phase 4

• 2 other identifiers: PESAPRO-20122012-000241-13
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 27

Brief Summary

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.

Conditions

Early Onset of Delivery Before 37 Weeks

Outcome Measures

Primary Outcomes (1)

• Proportion of spontaneous preterm birth before 34 weeks of gestation

  up to 11 weeks (from date of randomization until delivery)

Secondary Outcomes (10)

• Proportion of spontaneous preterm birth before 37 weeks of gestation

  up to 17 weeks (from date of randomization until delivery)

• Proportion of Spontaneous preterm birth before 28 weeks of gestation

  up to 8 weeks (from date of randomization until delivery)

• Rate of premature rupture of membranes before 34 weeks of gestation

  up to 11 weeks (from date of randomization until delivery)

• Weight at birth

  up to 21 weeks (from date of randomization until delivery)

• Rate of fetal and neonatal mortality

  From date of randomization until the date of delivery, assessed up 21 weeks

Study Arms (2)

Vaginal micronized progesterone

EXPERIMENTAL

200 mg vaginal route per day

Drug: Vaginal micronized progesterone

Cervical pessary

ACTIVE COMPARATOR

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

Interventions

Vaginal micronized progesterone DRUG

200 mg vaginal route per day

Vaginal micronized progesterone

Cervical pessary DEVICE

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)

Cervical pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dra.Cristina Martinez Payo: lead

Study Sites (27)

University Hospital San Juan de Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

University Hospital Quiron Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Igualada Hospital

Igualada, Barcelona, 08700, Spain

Location

Burgos University Hospital

Burgos, Burgos, 09006, Spain

Location

Ciudad Real General University Hospital

Ciudad Real, Ciudad Real, 13005, Spain

Location

Guadalajara General University Hospital

Guadalajara, Guadalajara, 19002, Spain

Location

University Hospital de León

León, León, 24071, Spain

Location

University Hospital Príncipe de Asturias

Alcalá de Henarés, Madrid, 28805, Spain

Location

University Hospital Fundación de Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

University Hospital Madrid Monte Principe

Boadilla del Monte, Madrid, 28660, Spain

Location

University Hospital Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

University Hospital de Getafe

Getafe, Madrid, 28905, Spain

Location

University Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Sanitas La Zarzuela Hospital

Madrid, Madrid, 28023, Spain

Location

University Hospital Ramón y Cajal

Madrid, Madrid, 28046, Spain

Location

Sanitas La Moraleja Hospital

Madrid, Madrid, 28050, Spain

Location

University Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

University Hospital Rey Juan Carlos I

Móstoles, Madrid, 28933, Spain

Location

University Hospital Mostoles

Móstoles, Madrid, 28935, Spain

Location

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Infanta Elena

Valdemoro, Madrid, 28040, Spain

Location

University Hospital Quirón Málaga

Málaga, Málaga, 29004, Spain

Location

Palamos Hospital

Girona, Palamos, 17320, Spain

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, San Sebastian, 20080, Spain

Location

Valladolid Clinic Universitary Hospital

Valladolid, Valladolid, 47005, Spain

Location

University Hospital Rio Hortega

Valladolid, Valladolid, 47012, Spain

Location

University Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (2)

• Cruz-Melguizo S, San-Frutos L, Martinez-Payo C, Ruiz-Antoran B, Adiego-Burgos B, Campillos-Maza JM, Garcia-Gonzalez C, Martinez-Guisasola J, Perez-Carbajo E, Teulon-Gonzalez M, Avendano-Sola C, Perez-Medina T. Cervical Pessary Compared With Vaginal Progesterone for Preventing Early Preterm Birth: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):907-915. doi: 10.1097/AOG.0000000000002884.

  PMID: 30204689 DERIVED

• Cabrera-Garcia L, Cruz-Melguizo S, Ruiz-Antoran B, Torres F, Velasco A, Martinez-Payo C, Avendano-Sola C; PESAPRO trial Group. Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:427. doi: 10.1186/s13063-015-0964-y.

  PMID: 26407852 DERIVED

Study Officials

• Sara Cruz Melguizo, Dr

  University Hospital Puerta de Hierro Majadahonda

  PRINCIPAL INVESTIGATOR

• Cristina Martinez Payo, Dr.

  University Hospital Puerta de Hierro Majadahonda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: July 18, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

ES (27)