Back to resultsCervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
Primary Purpose
Premature Birth
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arabin Pessary
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth focused on measuring arabin pessary, short cervix
Eligibility Criteria
Inclusion Criteria:
- singleton
- cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
- agrees to refrain from sexual intercourse
Exclusion Criteria:
- major fetal anomalies
- painful regular uterine contractions
- active vaginal bleeding
- ruptured membranes
- evidence of chorioamnionitis or other maternal/fetal infectious morbidity
- placenta previa
- cervical cerclage in situ
- visual cervical dilation of 2 cm or greater with visible amnion/chorion
- significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
Sites / Locations
- University of Kansas Medical Center
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Device: Arabin Pessary
Standard of Care
Arm Description
Participants randomized to this group will receive the pessary.
Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
Outcomes
Primary Outcome Measures
Preterm Birth Before 37 Weeks
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Secondary Outcome Measures
Preterm Birth Before 34 Weeks
Number of deliveries before 34 weeks 0 days of gestation
Neonatal Composite Morbidity
Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis
Neonatal Length of Stay
Total number of days in hospital after birth
Admission to Neonatal Intensive Care Unit
Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
Total Days in the Neonatal Intensive Care Unit
Number of days a baby spends in the neonatal intensive care unit
Duration of Ventilator Support
Number of days a baby requires use of mechanical ventilation
Retinopathy of Prematurity Requiring Treatment
Number of newborn with Retinopathy of Prematurity that requires intervention.
Birthweight < 1500 Grams
Number of newborns whose birthweight is less than 1500 grams
Birthweight < 2500 Grams
Number of newborns whose birthweight is less than 2500 grams
Gestational Age at Delivery
Number of weeks of gestation completed by time of delivery
Use of Tocolysis
Number of participants required use of tocolytic medication
Use of Antenatal Steroids
Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
Chorioamnionitis
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Vaginal Bleeding
Number of participants who experienced bleeding from lower genital tract during antepartum period
Preterm Premature Rupture of Membranes
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Cesarean Delivery
Number of participants that underwent cesarean delivery
Full Information
NCT ID
NCT02357394
First Posted
January 13, 2015
Last Updated
October 30, 2019
Sponsor
Gene Lee, MD
Collaborators
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02357394
Brief Title
Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
Official Title
Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit patients
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 6, 2017 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gene Lee, MD
Collaborators
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
Detailed Description
This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
arabin pessary, short cervix
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device: Arabin Pessary
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive the pessary.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
Intervention Type
Device
Intervention Name(s)
Arabin Pessary
Intervention Description
Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.
Primary Outcome Measure Information:
Title
Preterm Birth Before 37 Weeks
Description
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Time Frame
Up to 37 weeks 0 days
Secondary Outcome Measure Information:
Title
Preterm Birth Before 34 Weeks
Description
Number of deliveries before 34 weeks 0 days of gestation
Time Frame
up to 34 weeks 0 days
Title
Neonatal Composite Morbidity
Description
Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis
Time Frame
antepartum and up to 28 days after postnatal gestational age of 36 weeks
Title
Neonatal Length of Stay
Description
Total number of days in hospital after birth
Time Frame
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Title
Admission to Neonatal Intensive Care Unit
Description
Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
Time Frame
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Title
Total Days in the Neonatal Intensive Care Unit
Description
Number of days a baby spends in the neonatal intensive care unit
Time Frame
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Title
Duration of Ventilator Support
Description
Number of days a baby requires use of mechanical ventilation
Time Frame
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Title
Retinopathy of Prematurity Requiring Treatment
Description
Number of newborn with Retinopathy of Prematurity that requires intervention.
Time Frame
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Title
Birthweight < 1500 Grams
Description
Number of newborns whose birthweight is less than 1500 grams
Time Frame
at time of birth, expected to be within 4 weeks of due date
Title
Birthweight < 2500 Grams
Description
Number of newborns whose birthweight is less than 2500 grams
Time Frame
at time of birth, expected to be within 4 weeks of due date
Title
Gestational Age at Delivery
Description
Number of weeks of gestation completed by time of delivery
Time Frame
at time of birth, expected to be within 4 weeks of due date
Title
Use of Tocolysis
Description
Number of participants required use of tocolytic medication
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Use of Antenatal Steroids
Description
Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Chorioamnionitis
Description
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Vaginal Bleeding
Description
Number of participants who experienced bleeding from lower genital tract during antepartum period
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Preterm Premature Rupture of Membranes
Description
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Cesarean Delivery
Description
Number of participants that underwent cesarean delivery
Time Frame
at time of delivery, expected to be within 4 weeks of due date
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
singleton
cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
agrees to refrain from sexual intercourse
Exclusion Criteria:
major fetal anomalies
painful regular uterine contractions
active vaginal bleeding
ruptured membranes
evidence of chorioamnionitis or other maternal/fetal infectious morbidity
placenta previa
cervical cerclage in situ
visual cervical dilation of 2 cm or greater with visible amnion/chorion
significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene T Lee, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene Y Chang, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carl P Weiner, MD, MBA
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participating in GoNet IPD of pessary for prevention of preterm birth.
Citations:
PubMed Identifier
23055333
Citation
Carreras E, Arevalo S, Bello-Munoz JC, Goya M, Rodo C, Sanchez-Duran MA, Peiro JL, Cabero L. Arabin cervical pessary to prevent preterm birth in severe twin-to-twin transfusion syndrome treated by laser surgery. Prenat Diagn. 2012 Dec;32(12):1181-5. doi: 10.1002/pd.3982. Epub 2012 Oct 11.
Results Reference
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PubMed Identifier
22475493
Citation
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. Erratum In: Lancet. 2012 May 12;379(9828):1790.
Results Reference
background
PubMed Identifier
22871155
Citation
Ting YH, Lao TT, Wa Law L, Hui SY, Chor CM, Lau TK, Yeung Leung T. Arabin cerclage pessary in the management of cervical insufficiency. J Matern Fetal Neonatal Med. 2012 Dec;25(12):2693-5. doi: 10.3109/14767058.2012.712559. Epub 2012 Aug 22.
Results Reference
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PubMed Identifier
19530009
Citation
Sieroszewski P, Jasinski A, Perenc M, Banach R, Oszukowski P. The Arabin pessary for the treatment of threatened mid-trimester miscarriage or premature labour and miscarriage: a case series. J Matern Fetal Neonatal Med. 2009 Jun;22(6):469-72. doi: 10.1080/14767050802531748.
Results Reference
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PubMed Identifier
12747228
Citation
Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017.
Results Reference
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PubMed Identifier
2198191
Citation
Quaas L, Hillemanns HG, du Bois A, Schillinger H. [The Arabin cerclage pessary--an alternative to surgical cerclage]. Geburtshilfe Frauenheilkd. 1990 Jun;50(6):429-33. doi: 10.1055/s-2008-1026276. German.
Results Reference
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PubMed Identifier
23924878
Citation
Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
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Citation
Liem SM, van Baaren GJ, Delemarre FM, Evers IM, Kleiverda G, van Loon AJ, Langenveld J, Schuitemaker N, Sikkema JM, Opmeer BC, van Pampus MG, Mol BW, Bekedam DJ. Economic analysis of use of pessary to prevent preterm birth in women with multiple pregnancy (ProTWIN trial). Ultrasound Obstet Gynecol. 2014 Sep;44(3):338-45. doi: 10.1002/uog.13432. Epub 2014 Aug 7.
Results Reference
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Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
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