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Preterm DeliveryPhase 34PNCT00536003

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

A Phase 3 study testing progesterone in people with Preterm Delivery and Morbidity, run by begoña Martinez de Tejada at 33 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Preterm Delivery, Morbidity, Perinatal Mortality
What is being tested?
progesterone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
384 participants
Where
33 sitesin 2 countries
Study dates
Jul 2006to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 2 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

Argentina24 sites

  • Hospital Interzonal Alberto Antranik Eurnekian

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

  • Hospital Carlos G. Durand

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

  • Instituto Universitario CEMIC

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

  • Hospital Bernardino Rivadavia

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

  • Hospital Mariano y Luciano de la Vega

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

  • Hospital Maternidad Nuestra Señora De Las Mercedes

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

  • Hospital Villa Dolores

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

  • Hospital J. B. Iturraspe

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

  • Hospital Comunal de Tigre

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

  • Hospital Materno Infantil de San Isidro

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

  • Hospital Virgen del Carmen

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

  • Hospital Dr. T. Alvarez

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

  • Hospital Materno Infantil Ramón Sardá

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

  • Hospital Municipal Materno Infantil Comodoro Meisner

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

  • Hospital Italiano de Buenos Aires

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

  • Hospital Materno Infantil San Roque

    Buenos Aires, La Paz 435, Provincia de Entre Ríos

  • Hospital Municipal Ostaciana B. de Lavignolle

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

  • Hospital J. M. Penna

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

  • Hospital Donación Francisco Santojanni

    Buenos Aires, Pilar 950, Ciudad Autónoma de Buenos Aires

  • Hospital Dr. Cosme Argerich

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

  • Hospital Dr. Arturo Oñativia

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

  • Hospital Héroes de Malvinas

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

  • Hospital Magdalena V. de Martínez

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

  • Hospital Dr. Carlos Bocalandro

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

Other trials in Argentina

Switzerland9 sites

  • Universitäts-Frauenklinik Kantonespital Basel

    Basel, Basel, 4031

  • Universitätsfrauenklinik Bern

    Bern, Canton of Bern, 3010

  • Kantonales Frauenspital Chur

    Chur, Chur, 7000

  • Maternity of the University Hospital of Geneva

    Geneva, Canton of Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Lausanne, 1011

  • Frauenklinik Kantonspital Luzern

    Lucerne, Canton of Lucerne

  • Frauenklinik Kantonspital St Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

  • Frauenklinik Kantonspital Winterthur

    Winterthur, Winterthur, 8401

  • University Hospital Zürich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

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.

Read the detailed description

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. 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 infant mortality and morbidity.

Being tested
progesterone, placebo
Keywords
preterm delivery, preterm labor, perinatal morbidity, perinatal mortality
Medical subject headings
Premature Birth, Perinatal Death, Obstetric Labor, Premature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • progesteroneDrug

    Also called Utrogestan

    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).

  • placeboDrug

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

Study groups in NCT00536003
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: progesterone
2Placebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: end of pregnancy

Secondary outcomes (1)

  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

    Measured: end of pregnancy and 28 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2007 (estimated)
  2. Study startJul 2006
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00536003
Sponsor's protocol ID
CER: 04-196
Other IDs
matped 04-001
Acronym
4P
Status last verified
Jun 2012
First submitted
24 Sep 2007
Last updated
6 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25209926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing progesterone in people with Preterm Delivery and Morbidity, run by begoña Martinez de Tejada at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Argentina, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation (time frame: end of pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00536003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.

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