NCT00536003

Brief Summary

The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_3

Geographic Reach
2 countries

33 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

6.4 years

First QC Date

September 24, 2007

Last Update Submit

June 5, 2012

Conditions

Preterm DeliveryMorbidityPerinatal Mortality

Keywords

preterm deliverypreterm laborperinatal morbidityperinatal mortality

Outcome Measures

Primary Outcomes (1)

  • The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation

    end of pregnancy

Secondary Outcomes (1)

  • Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects

    end of pregnancy and 28 days after delivery

Study Arms (2)

1

EXPERIMENTAL
Drug: progesterone

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

progesteroneDRUG

vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

Also known as: Utrogestan
1
placeboDRUG

vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)
  • Singleton pregnancy
  • Intact membranes
  • Preterm labor defined as:
  • or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:
  • short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)
  • cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6
  • cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)
  • positive fetal fibronectin
  • Age ≥ 18 years old
  • Signed informed consent
  • Possible and accepted follow-up

You may not qualify if:

  • Multiple gestation
  • Cervical cerclage
  • Hydramnios (AFI \>95th percentile for gestational age or greatest pocket \>8 cm)
  • Premature rupture of membranes
  • Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)
  • Cervical dilatation \> 3 cm
  • Placenta praevia or abruptio placentae
  • Intra-uterine growth restriction or non-reassuring fetal status
  • Pre-eclampsia or severe hypertension
  • Any other maternal or fetal pathology which should indicate medically preterm delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Hospital Interzonal Alberto Antranik Eurnekian

Buenos Aires, Alem 349, Ezeiza, Provincia de Buenos Aires, Argentina

Location

Hospital Carlos G. Durand

Buenos Aires, Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires, Argentina

Location

Instituto Universitario CEMIC

Buenos Aires, Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires, Argentina

Location

Hospital Bernardino Rivadavia

Buenos Aires, Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires, Argentina

Location

Hospital Mariano y Luciano de la Vega

Buenos Aires, Av. Libertador 710, Moreno, Provincia de Buenos Aires, Argentina

Location

Hospital Maternidad Nuestra Señora De Las Mercedes

Buenos Aires, Av. Mate de Luna 1555, Provincia de Tucumán, Argentina

Location

Hospital Villa Dolores

Buenos Aires, Belgrano 1500, Villa Dolores, Provincia de Códoba, Argentina

Location

Hospital J. B. Iturraspe

Buenos Aires, Bvd. Pellegrini 3551, Provincia de Santa Fe, Argentina

Location

Hospital Comunal de Tigre

Buenos Aires, Casareto 118, Tigre, Provincia de Buenos Aires, Argentina

Location

Hospital Materno Infantil de San Isidro

Buenos Aires, Diego Palma 505, San Isidro, Provincia de Buenos Aires, Argentina

Location

Hospital Virgen del Carmen

Buenos Aires, Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires, Argentina

Location

Hospital Dr. T. Alvarez

Buenos Aires, Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A., Argentina

Location

Hospital Materno Infantil Ramón Sardá

Buenos Aires, Esteban de Luca 2151, Ciudad Autónoma de Buenos Aires, Argentina

Location

Hospital Municipal Materno Infantil Comodoro Meisner

Buenos Aires, Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires, Argentina

Location

Hospital Materno Infantil San Roque

Buenos Aires, La Paz 435, Provincia de Entre Ríos, Argentina

Location

Hospital Municipal Ostaciana B. de Lavignolle

Buenos Aires, Monte 848, Morón, Provincia de Buenos Aires, Argentina

Location

Hospital J. M. Penna

Buenos Aires, Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires, Argentina

Location

Hospital Donación Francisco Santojanni

Buenos Aires, Pilar 950, Ciudad Autónoma de Buenos Aires, Argentina

Location

Hospital Dr. Cosme Argerich

Buenos Aires, Py Y Margall 750, Cuidad Autónoma de Buenos Aires, Argentina

Location

Hospital Dr. Arturo Oñativia

Buenos Aires, Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires, Argentina

Location

Hospital Héroes de Malvinas

Buenos Aires, Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires, Argentina

Location

Hospital Magdalena V. de Martínez

Buenos Aires, Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A., Argentina

Location

Hospital Dr. Carlos Bocalandro

Buenos Aires, Ruta 8Km. 20,5 N°9100, Loma Hermosa, Provincia de Buenos Aires, Argentina

Location

Universitäts-Frauenklinik Kantonespital Basel

Basel, Basel, 4031, Switzerland

Location

Universitätsfrauenklinik Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Maternity of the University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Frauenklinik Kantonspital Luzern

Lucerne, Canton of Lucerne, Switzerland

Location

Frauenklinik Kantonspital St Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

University Hospital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Kantonales Frauenspital Chur

Chur, Chur, 7000, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Lausanne, 1011, Switzerland

Location

Frauenklinik Kantonspital Winterthur

Winterthur, Winterthur, 8401, Switzerland

Location

Related Publications (1)

  • Martinez de Tejada B, Karolinski A, Ocampo MC, Laterra C, Hosli I, Fernandez D, Surbek D, Huespe M, Drack G, Bunader A, Rouillier S, Lopez de Degani G, Seidenstein E, Prentl E, Anton J, Krahenmann F, Nowacki D, Poncelas M, Nassif JC, Papera R, Tuma C, Espoile R, Tiberio O, Breccia G, Messina A, Peker B, Schinner E, Mol BW, Kanterewicz L, Wainer V, Boulvain M, Othenin-Girard V, Bertolino MV, Irion O; 4P trial group. Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial. BJOG. 2015 Jan;122(1):80-91. doi: 10.1111/1471-0528.13061. Epub 2014 Sep 11.

    PMID: 25209926DERIVED

MeSH Terms

Conditions

Premature BirthPerinatal DeathObstetric Labor, Premature

Interventions

ProgesteroneUtrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Begona Martinez de Tejada, MD, PhD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 27, 2007

Study Start

July 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

AR(24)CH(9)