A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
NCT ID: NCT02901626
Last Updated: 2023-06-22
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
544 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-02-14
Study Completion Date
2022-05-10
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Short Cervix
Preterm Delivery
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Arabin Cervical Pessary
Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Group Type
EXPERIMENTAL
Arabin Cervical Pessary
Intervention Type
DEVICE
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
No Pessary
Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Arabin Cervical 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
Intervention Type
DEVICE
Other Intervention Names
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Arabin pessary
Eligibility Criteria
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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 by a study certified sonographer. There is no lower cervical length threshold.
* 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 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.
* 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.
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
The George Washington University Biostatistics Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rebecca Clifton, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center
Monica Longo, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Matthew Hoffman, MD
Role: STUDY_CHAIR
Christiana Care Health Services
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
Site Status
Northwestern University
Chicago, Illinois, United States
Site Status
Columbia University
New York, New York, United States
Site Status
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Site Status
Case Western Reserve University
Cleveland, Ohio, United States
Site Status
Ohio State University
Columbus, Ohio, United States
Site Status
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
Magee Womens
Pittsburgh, Pennsylvania, United States
Site Status
Brown University
Providence, Rhode Island, United States
Site Status
University of Texas Medical Branch
Galveston, Texas, United States
Site Status
University of Texas - Houston
Houston, Texas, United States
Site Status
University of Utah
Salt Lake City, Utah, United States
Site Status
Countries
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United States
References
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Conde-Agudelo A, Romero R, Nicolaides K, Chaiworapongsa T, O'Brien JM, Cetingoz E, da Fonseca E, Creasy G, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone vs. cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis. Am J Obstet Gynecol. 2013 Jan;208(1):42.e1-42.e18. doi: 10.1016/j.ajog.2012.10.877. Epub 2012 Nov 15.
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Facco FL, Simhan HN. Short ultrasonographic cervical length in women with low-risk obstetric history. Obstet Gynecol. 2013 Oct;122(4):858-862. doi: 10.1097/AOG.0b013e3182a2dccd.
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Hoffman MK, Clifton RG, Biggio JR, Saade GR, Ugwu LG, Longo M, Bousleiman SZ, Clark K, Grobman WA, Frey HA, Chauhan SP, Dugoff L, Manuck TA, Chien EK, Rouse DJ, Simhan HN, Esplin MS, Macones GA; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):340-348. doi: 10.1001/jama.2023.10812.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HD36801 - TOPS
Identifier Type: -
Identifier Source: org_study_id
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Prevention and Treatment of Premature Labour for Asymptomatic Pregnant Women
NCT02598323
UNKNOWN
NA
Vaginal Progesterone in Twin With Short Cervix
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COMPLETED
PHASE3
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
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TERMINATED
PHASE3
Progesterone and Cervical Pessary in Twins
NCT03058536
UNKNOWN
PHASE2/PHASE3
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
NCT03251729
COMPLETED
PHASE4
Prospective Evaluation of Pathways for Preterm Birth
NCT05246579
RECRUITING
Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth
NCT02511574
COMPLETED
PHASE4
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins
NCT01242410
COMPLETED
PHASE4