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

NCT ID: NCT01643980

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Early Onset of Delivery Before 37 Weeks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaginal micronized progesterone

200 mg vaginal route per day

Group Type: EXPERIMENTAL

Vaginal micronized progesterone

Intervention Type: DRUG

200 mg vaginal route per day

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)

Group Type: ACTIVE_COMPARATOR

Cervical pessary

Intervention Type: 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)

Interventions

Vaginal micronized progesterone

200 mg vaginal route per day

Intervention Type: DRUG

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)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dra.Cristina Martinez Payo

OTHER

Sponsor Role: lead

Responsible Party

Dra.Cristina Martinez Payo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sara Cruz Melguizo, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Puerta de Hierro Majadahonda

Cristina Martinez Payo, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Puerta de Hierro Majadahonda

Locations

University Hospital San Juan de Alicante

Sant Joan d'Alacant, Alicante, Spain

University Hospital Quiron Dexeus

Barcelona, Barcelona, Spain

Igualada Hospital

Igualada, Barcelona, Spain

Burgos University Hospital

Burgos, Burgos, Spain

Ciudad Real General University Hospital

Ciudad Real, Ciudad Real, Spain

Guadalajara General University Hospital

Guadalajara, Guadalajara, Spain

University Hospital de León

León, León, Spain

University Hospital Príncipe de Asturias

Alcalá de Henarés, Madrid, Spain

University Hospital Fundación de Alcorcón

Alcorcón, Madrid, Spain

University Hospital Madrid Monte Principe

Boadilla del Monte, Madrid, Spain

University Hospital Fuenlabrada

Fuenlabrada, Madrid, Spain

University Hospital de Getafe

Getafe, Madrid, Spain

University Hospital Severo Ochoa

Leganés, Madrid, Spain

Sanitas La Zarzuela Hospital

Madrid, Madrid, Spain

University Hospital Ramón y Cajal

Madrid, Madrid, Spain

Sanitas La Moraleja Hospital

Madrid, Madrid, Spain

University Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

University Hospital Rey Juan Carlos I

Móstoles, Madrid, Spain

University Hospital Mostoles

Móstoles, Madrid, Spain

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain

Hospital Infanta Elena

Valdemoro, Madrid, Spain

University Hospital Quirón Málaga

Málaga, Málaga, Spain

Palamos Hospital

Girona, Palamos, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, San Sebastian, Spain

Valladolid Clinic Universitary Hospital

Valladolid, Valladolid, Spain

University Hospital Rio Hortega

Valladolid, Valladolid, Spain

University Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30204689 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26407852 (View on PubMed)

Other Identifiers

2012-000241-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PESAPRO-2012

Identifier Type: -

Identifier Source: org_study_id