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A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix (TOPS)

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ClinicalTrials.gov Identifier: NCT02901626
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Brief Summary:
The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.

Condition or disease Intervention/treatment Phase
Short Cervix Preterm Delivery Device: Pessary Not Applicable

Detailed Description:

While cervical length is one of the most powerful predictors of subsequent preterm birth, the best treatment to reduce subsequent preterm birth remains unknown. This study is a randomized trial of women who have a singleton pregnancy and a short cervical length on transvaginal ultrasound as determined by a study-certified sonographer. It is being conducted at 12 clinical centers across the country and the recruitment target is enrollment of 850 pregnant women. Participants will be randomized to 1) Arabin pessary or 2) usual care as per by local hospital protocol. Pessary is a promising low-cost, non-surgical intervention that appears to be well-tolerated. The pessary will be placed by obstetric providers trained in appropriate placement of the Arabin pessary. The primary outcome of the study is delivery or fetal death prior to 37 weeks 0 days gestational age.

In the literature, there are two large trials that have produced conflicting results (M Goya et al, 2012, K Nicolaides et al, 2016). Thus, the results of an adequately powered and appropriately conducted trial from the United States will be important in determining whether pessary is a useful intervention for the prevention of subsequent preterm birth in women with singleton gestation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is an unblinded randomized controlled trial. Participants will receive usual care (vaginal progesterone if they meet criteria per local standard of care) or an Arabin cervical pessary (plus progesterone if the local usual care is to receive vaginal progesterone for a short cervix).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : January 2024

Arm Intervention/treatment
Experimental: Pessary
Arabin pessary. Participants where local standard of care includes vaginal progesterone will also receive progesterone.
Device: Pessary

The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study:

Pessary Size Upper diameter, lower diameter

  1. Nulliparous 65 mm, 32 mm
  2. Multiparous 70 mm, 32 mm
  3. Alternative 70 mm, 35 mm
Other Name: Arabin pessary

No Intervention: No Pessary
Participants that do not receive a pessary will receive the usual standard of care, including vaginal progesterone if that is the local standard.



Primary Outcome Measures :
  1. Delivery or fetal demise [ Time Frame: Before 37 weeks 0 days ]
    Delivery of the infant or fetal demise.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton gestation. Twin gestation reduced to singleton either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher order multifetal gestations reduced to singletons are not eligible.
  • Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
  • Cervical length on transvaginal examination of less than or equal to 20 mm within 10 days prior to randomization by a study certified sonographer. There is no lower cervical length threshold.

Exclusion Criteria:

  • Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization.
  • Fetal anomaly or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities. An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project Estimated Date of Confinement (EDC) must be performed prior to randomization to evaluate the fetus for anomalies.
  • Previous spontaneous preterm birth between 16 weeks 0 days and 36 weeks 6 days. This includes induction for pPROM in a prior pregnancy.
  • Planned treatment with intramuscular 17-α hydroxy-progesterone caproate.
  • Placenta previa, because of risk of bleeding and high potential for indicated preterm birth. A low lying placenta is acceptable.
  • Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement.
  • Symptomatic, untreated vaginal or cervical infection because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized. However, if it is more than 10 days since the cervical length measurement, a new cervical length measurement must be obtained.
  • Active, unhealed herpetic lesion on labia minora, vagina, or cervix due to the potential for significant patient discomfort or increasing genital tract viral spread. Once lesion(s) heal and the patient is asymptomatic, she may be randomized. History of herpes is not an exclusion.
  • Rupture of membranes due to likelihood of pregnancy loss and preterm delivery as well as the risk of ascending infection which could be increased with pessary placement.
  • More than six contractions per hour reported or documented prior to randomization. It is not necessary to place the patient on a tocodynamometer.
  • Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery which is unlikely to be affected by progesterone.
  • Any fetal/maternal condition which would require invasive in-utero assessment or treatment, for example significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.
  • Major maternal medical illness associated with increased risk for adverse pregnancy outcome or indicated preterm birth (treated hypertension requiring more than one agent, treatment for diabetes prior to pregnancy, chronic renal insufficiency defined by creatinine >1.4 mg/dL, carcinoma of the breast, conditions treated with chronic oral glucocorticoid therapy). Lupus, uncontrolled thyroid disease, and New York Heart Association(NYHA) stage II or greater cardiac disease are also excluded. Patients with seizure disorders, HIV, and other medical conditions not specifically associated with an increased risk of indicated preterm birth are not excluded. Prior cervical cone/LOOP/Loop Electrocautery Excision Procedure (LEEP) is not an exclusion criterion.
  • Planned cerclage or cerclage already in place since it would preclude placement of a pessary.
  • Planned indicated delivery prior to 37 weeks.
  • Allergy to silicone.
  • Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality.
  • Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
  • Prenatal care or delivery planned elsewhere unless the study visits can be made as scheduled and complete outcome information can be obtained.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901626


Contacts
Contact: Uma Reddy, M.D. 301-496-1074 uma.reddy@nih.gov
Contact: Elizabeth Thom, Ph.D. 301-881-9260 e_thom@bsc.gwu.edu

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, BSN    205-996-6262    stacylharris@uabmc.edu   
Principal Investigator: Alan T. Tita, M.D.         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN,BSN, CCRC    312-503-3200    g-mallett@northwestern.edu   
Principal Investigator: William Grobman, M.D.         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, MSN, MSPH    212-305-4348    sb1080@cumc.columbia.edu   
Principal Investigator: Cynthia Gyamfi-Bannerman, M.D.         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Clark, RN    919-350-6117    Kelly_clark@med.unc.edu   
Principal Investigator: John Thorp, M.D.         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RNC    216-778-7533    WDalton@metrohealth.org   
Principal Investigator: Edward Chien, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Anna Bartholomew, RN,BSN,CCRP    614-685-3229    Anna.Bartholomew@osumc.edu   
Principal Investigator: Catalin Buhimschi, M.D.         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Hammond, BSN    267-584-0084    Mary.Hammond@uphs.upenn.edu   
Principal Investigator: Samuel Parry, M.D.         
Magee Womens Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, BS, RN    412-641-4072    bickmt2@mail.magee.edu   
Principal Investigator: Hyagriv Simhan, M.D.         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RNC    401-274-1122 ext 48522    DAllard@wihri.org   
Principal Investigator: Dwight J. Rouse, M.D.         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN,    409-772-0312    assalaza@utmb.edu   
Principal Investigator: George Saade, M.D.         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN,BSN,CCRC    713-500-6467    Felecia.Ortiz@uth.tmc.edu   
Principal Investigator: Suneet Chauhan, M.D.         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN,BSN,CCRP    801-585-7645    kim.hill@hsc.utah.edu   
Principal Investigator: Michael Varner, M.D.         
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Elizabeth Thom, Ph.D. George Washington University Biostatistics Center

Publications:

Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT02901626     History of Changes
Other Study ID Numbers: HD36801 - TOPS
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD027915 ( U.S. NIH Grant/Contract )
UG1HD034208 ( U.S. NIH Grant/Contract )
UG1HD040500 ( U.S. NIH Grant/Contract )
UG1HD040485 ( U.S. NIH Grant/Contract )
UG1HD053097 ( U.S. NIH Grant/Contract )
UG1HD040544 ( U.S. NIH Grant/Contract )
UG1HD040545 ( U.S. NIH Grant/Contract )
UG1HD040560 ( U.S. NIH Grant/Contract )
UG1HD040512 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
UG1HD027869 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared after the completion of the trial and publication of the main analyses per NIH policy. When made available, requests for the dataset(s) can be sent to mfmudatasets@bsc.gwu.edu.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by The George Washington University Biostatistics Center:
Short cervix
Preterm delivery
Singletons
Pregnancy
Pessary

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications