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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Arabin Pessary | Experimental | Participants randomized to this group will receive the pessary. |
|
| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arabin Pessary | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 37 weeks 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth Before 34 Weeks | Number of deliveries before 34 weeks 0 days of gestation | up to 34 weeks 0 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gene T Lee, MD | University of Kansas Medical Center | Principal Investigator |
| Eugene Y Chang, MD | Medical University of South Carolina | Principal Investigator |
| Carl P Weiner, MD, MBA | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Medical University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23055333 | Background | 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. | |
| 22475493 | Background |
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Participating in GoNet IPD of pessary for prevention of preterm birth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device: Arabin Pessary | Participants randomized to this group will receive the pessary. Arabin Pessary: 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. |
| FG001 | Standard of Care | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device: Arabin Pessary | Participants randomized to this group will receive the pessary. Arabin Pessary: 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. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 37 weeks 0 days |
|
1 year, 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device: Arabin Pessary | Participants randomized to this group will receive the pessary. Arabin Pessary: 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. |
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Study closed due to poor enrollment, unable to complete.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gene Lee | University of Kansas Health System, Dept of OBGYN | 9135886201 | glee@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2019 | Oct 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| antepartum and up to 28 days after postnatal gestational age of 36 weeks |
| Neonatal Length of Stay | Total number of days in hospital after birth | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
| Admission to Neonatal Intensive Care Unit | Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay. | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
| Total Days in the Neonatal Intensive Care Unit | Number of days a baby spends in the neonatal intensive care unit | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
| Duration of Ventilator Support | Number of days a baby requires use of mechanical ventilation | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
| Retinopathy of Prematurity Requiring Treatment | Number of newborn with Retinopathy of Prematurity that requires intervention. | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
| Birthweight < 1500 Grams | Number of newborns whose birthweight is less than 1500 grams | at time of birth, expected to be within 4 weeks of due date |
| Birthweight < 2500 Grams | Number of newborns whose birthweight is less than 2500 grams | at time of birth, expected to be within 4 weeks of due date |
| Gestational Age at Delivery | Number of weeks of gestation completed by time of delivery | at time of birth, expected to be within 4 weeks of due date |
| Use of Tocolysis | Number of participants required use of tocolytic medication | participants will be followed for the duration of pregnancy, up to nine months |
| Use of Antenatal Steroids | Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery | participants will be followed for the duration of pregnancy, up to nine months |
| Chorioamnionitis | Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia. | participants will be followed for the duration of pregnancy, up to nine months |
| Vaginal Bleeding | Number of participants who experienced bleeding from lower genital tract during antepartum period | participants will be followed for the duration of pregnancy, up to nine months |
| 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. | participants will be followed for the duration of pregnancy, up to nine months |
| Cesarean Delivery | Number of participants that underwent cesarean delivery | at time of delivery, expected to be within 4 weeks of due date |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| 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. |
| 22871155 | Background | 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. |
| 19530009 | Background | 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. |
| 12747228 | Background | 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. |
| 2198191 | Background | 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. |
| 23924878 | Background | 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. |
| 24898103 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| marital status | Count of Participants | Participants |
|
| employment status | Count of Participants | Participants |
|
| years education | missing data | Mean | Full Range | years |
|
| insurance group | Count of Participants | Participants |
|
| tobacco use | Count of Participants | Participants |
|
| alcohol use | Count of Participants | Participants |
|
| prepreg BMI | Mean | Full Range | kg/m^2 |
|
| infections before enrollment | Count of Participants | Participants |
|
| infections at enrollment | Count of Participants | Participants |
|
| nullipara | Count of Participants | Participants |
|
| # of pregnancies < 16 wk delivered spontaneously | Mean | Full Range | pregnancies |
|
| # of pregnancies 16w0d-23w6d delivered spontaneously | Mean | Full Range | pregnancies |
|
| # of pregnancies 24w0d-36w6d delivered sponaneously | Mean | Full Range | pregnancies |
|
| prior operative vaginal delivery | Count of Participants | Participants |
|
| prior Cesarean | Count of Participants | Participants |
|
| prior cervical surgery | Count of Participants | Participants |
|
| gestational weeks at randomization | Mean | Full Range | weeks |
|
| TVCL at randomization | Mean | Full Range | millimeters |
|
| Funneling present | Count of Participants | Participants |
|
| sludge present | Count of Participants | Participants |
|
| progesterone started? | Count of Participants | Participants |
|
| cerclage placed? | Count of Participants | Participants |
|
|
|
| Secondary | Preterm Birth Before 34 Weeks | Number of deliveries before 34 weeks 0 days of gestation | Posted | Count of Participants | Participants | up to 34 weeks 0 days |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | antepartum and up to 28 days after postnatal gestational age of 36 weeks |
|
|
|
| Secondary | Neonatal Length of Stay | Total number of days in hospital after birth | Posted | Mean | Full Range | days | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
|
|
|
| Secondary | Admission to Neonatal Intensive Care Unit | Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay. | Posted | Count of Participants | Participants | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
|
|
|
| Secondary | Total Days in the Neonatal Intensive Care Unit | Number of days a baby spends in the neonatal intensive care unit | Posted | Mean | Full Range | days | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
|
|
|
| Secondary | Duration of Ventilator Support | Number of days a baby requires use of mechanical ventilation | Posted | Mean | Full Range | days | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
|
|
|
| Secondary | Retinopathy of Prematurity Requiring Treatment | Number of newborn with Retinopathy of Prematurity that requires intervention. | Posted | Count of Participants | Participants | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery |
|
|
|
| Secondary | Birthweight < 1500 Grams | Number of newborns whose birthweight is less than 1500 grams | Posted | Count of Participants | Participants | at time of birth, expected to be within 4 weeks of due date |
|
|
|
| Secondary | Birthweight < 2500 Grams | Number of newborns whose birthweight is less than 2500 grams | Posted | Count of Participants | Participants | at time of birth, expected to be within 4 weeks of due date |
|
|
|
| Secondary | Gestational Age at Delivery | Number of weeks of gestation completed by time of delivery | Posted | Mean | Full Range | weeks | at time of birth, expected to be within 4 weeks of due date |
|
|
|
| Secondary | Use of Tocolysis | Number of participants required use of tocolytic medication | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Use of Antenatal Steroids | Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Chorioamnionitis | Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia. | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Vaginal Bleeding | Number of participants who experienced bleeding from lower genital tract during antepartum period | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Cesarean Delivery | Number of participants that underwent cesarean delivery | Posted | Count of Participants | Participants | at time of delivery, expected to be within 4 weeks of due date |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Standard of Care | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D000091642 | Urogenital Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| part-time |
|
| government insurance |
|