NCT04147117

Brief Summary

DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women. METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations. MAIN OUTCOME: sPTB \<370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 25, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

October 16, 2019

Last Update Submit

June 2, 2020

Conditions

Preterm Birth

Keywords

Preterm BirthCervical PessaryObstetrical historyCervical length

Outcome Measures

Primary Outcomes (1)

  • Spontaneous preterm birth before 37 weeks of gestation

    Delivery \< 37.0 weeks of gestation (Yes/No)

    3 years

Secondary Outcomes (20)

  • Preterm birth 34 weeks

    5 months

  • Preterm birth 28 weeks

    5 months

  • PPROM before 34 weeks

    5 months

  • Threatened preterm labor

    5 months

  • Cervical trauma

    5 months

  • +15 more secondary outcomes

Study Arms (2)

Pessary Group

EXPERIMENTAL

A pessary certified is inserted through the vagina with the woman in recumbent position and is placed around the cervix. Correct placement of the pessary is assessed by ultrasound. Patients on the pessary group are specially awarded about adverse symptoms and the need of immediate report in case of pain, bleeding and symptomatic contractions. The pessary is not removed when symptoms of infection occur after pessary insertion, but appropriate treatment is given. The pessary is removed at 37 weeks of pregnancy. Indications for pessary removal before 37 weeks are: active vaginal bleeding, premature labor not responding to tocolysis or severe patient discomfort.

Device: Cervical pessary

Control group

NO INTERVENTION

Current management for the follow-up of these women in the PBPC.

Interventions

Cervical pessaryDEVICE

Cervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall.

Pessary Group

Eligibility Criteria

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

You may qualify if:

  • Singleton pregnancy.
  • Age \> 18 years old.
  • Gestational age between 18.0 -23.6 weeks of gestation.
  • Asymptomatic singleton pregnancies, with at least one of the following:
  • Previous spontaneous preterm delivery or PPROM (23 - 34.6 weeks).
  • Previous spontaneous second trimester miscarriage (16.0-22.6 weeks).
  • Previous surgery on uterine cervix.
  • Uterine malformation.
  • Able to sign informed consent form.

You may not qualify if:

  • Congenital, chromosomal abnormalities or stillbirth in current pregnancy before randomization.
  • Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
  • Symptomatic high-risk women or preterm prelabor rupture of membranes (PROM) in the current pregnancy.
  • Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
  • Cerclage in situ.
  • Active vaginal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Joan de Déu. BCNatal | Barcelona Center for Maternal Fetal and Neonatal Medicine | Hospital Clínic - Hospital Sant Joan de Déu

Barcelona, 08950, Spain

RECRUITING

Related Publications (16)

  • Beta J, Akolekar R, Ventura W, Syngelaki A, Nicolaides KH. Prediction of spontaneous preterm delivery from maternal factors, obstetric history and placental perfusion and function at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):75-83. doi: 10.1002/pd.2662.

    PMID: 21210482BACKGROUND

  • Sotiriadis A, Papatheodorou S, Kavvadias A, Makrydimas G. Transvaginal cervical length measurement for prediction of preterm birth in women with threatened preterm labor: a meta-analysis. Ultrasound Obstet Gynecol. 2010 Jan;35(1):54-64. doi: 10.1002/uog.7457.

    PMID: 20014326BACKGROUND

  • Celik E, To M, Gajewska K, Smith GC, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Cervical length and obstetric history predict spontaneous preterm birth: development and validation of a model to provide individualized risk assessment. Ultrasound Obstet Gynecol. 2008 May;31(5):549-54. doi: 10.1002/uog.5333.

    PMID: 18432605BACKGROUND

  • Owen J, Szychowski JM, Hankins G, Iams JD, Sheffield JS, Perez-Delboy A, Berghella V, Wing DA, Guzman ER; Vaginal Ultrasound Trial Consortium. Does midtrimester cervical length >/=25 mm predict preterm birth in high-risk women? Am J Obstet Gynecol. 2010 Oct;203(4):393.e1-5. doi: 10.1016/j.ajog.2010.06.025. Epub 2010 Aug 12.

    PMID: 20708169BACKGROUND

  • Care AG, Sharp AN, Lane S, Roberts D, Watkins L, Alfirevic Z. Predicting preterm birth in women with previous preterm birth and cervical length >/= 25 mm. Ultrasound Obstet Gynecol. 2014 Jun;43(6):681-6. doi: 10.1002/uog.13241.

    PMID: 24186101BACKGROUND

  • Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.

    PMID: 22284156BACKGROUND

  • Berghella V, Mackeen AD. Cervical length screening with ultrasound-indicated cerclage compared with history-indicated cerclage for prevention of preterm birth: a meta-analysis. Obstet Gynecol. 2011 Jul;118(1):148-155. doi: 10.1097/AOG.0b013e31821fd5b0.

    PMID: 21691173BACKGROUND

  • Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.

    PMID: 19788970BACKGROUND

  • Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA. Cervical pessary for preventing preterm birth. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007873. doi: 10.1002/14651858.CD007873.pub3.

    PMID: 23728668BACKGROUND

  • Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.

    PMID: 22475493BACKGROUND

  • Hui SY, Chor CM, Lau TK, Lao TT, Leung TY. Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial. Am J Perinatol. 2013 Apr;30(4):283-8. doi: 10.1055/s-0032-1322550. Epub 2012 Aug 8.

    PMID: 22875662BACKGROUND

  • Nicolaides KH, Syngelaki A, Poon LC, de Paco Matallana C, Plasencia W, Molina FS, Picciarelli G, Tul N, Celik E, Lau TK, Conturso R. Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial. Am J Obstet Gynecol. 2016 Jan;214(1):3.e1-9. doi: 10.1016/j.ajog.2015.08.051. Epub 2015 Aug 28.

    PMID: 26321037BACKGROUND

  • Orzechowski KM, Boelig RC, Berghella V. Cervical Length Screening in Asymptomatic Women at High Risk and Low Risk for Spontaneous Preterm Birth. Clin Obstet Gynecol. 2016 Jun;59(2):241-51. doi: 10.1097/GRF.0000000000000195.

    PMID: 27015227BACKGROUND

  • O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96. doi: 10.1002/uog.5158.

    PMID: 17899572BACKGROUND

  • DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.

    PMID: 17899571BACKGROUND

  • Dodd JM, Jones L, Flenady V, Cincotta R, Crowther CA. Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004947. doi: 10.1002/14651858.CD004947.pub3.

    PMID: 23903965BACKGROUND

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Silvia Irene Ferrero Martínez, MD,PhD

    BCNatal | Hospital Sant Joan de Déu - Hospital Clínic

    PRINCIPAL INVESTIGATOR

  • Montse Palacio Riera, MD,PhD

    BCNatal | Hospital Clínic- Hospital Sant Joan de Déu

    STUDY DIRECTOR

Central Study Contacts

Silvia Irene Ferrero Martínez, MD,PhD

CONTACT

+34932532100sferrero@sjdhospitalbarcelona.org

Núria Lorente Colomé, MD

CONTACT

+34932532100nlorente@sjdhospitalbarcelona.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 31, 2019

Study Start

October 25, 2017

Primary Completion

March 31, 2020

Study Completion

December 31, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)