Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix

• Sponsor: Gene Lee, MD (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02357394
• Collaborator: Medical University of South Carolina (Other)
• Enrollment: 7
• Locations: 2
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Device: Arabin Pessary	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 6, 2017
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device: Arabin Pessary Participants randomized to this group will receive the pessary.	Device: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Preterm Birth Before 37 Weeks [Up to 37 weeks 0 days]

   Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.

Secondary Outcome Measures

1. Preterm Birth Before 34 Weeks [up to 34 weeks 0 days]

   Number of deliveries before 34 weeks 0 days of gestation

2. Neonatal Composite Morbidity [antepartum and up to 28 days after postnatal gestational age of 36 weeks]

   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

3. Neonatal Length of Stay [participants will be followed for the duration of hospital stay, up to 17 weeks after delivery]

   Total number of days in hospital after birth

4. Admission to Neonatal Intensive Care Unit [participants will be followed for the duration of hospital stay, up to 17 weeks after delivery]

   Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.

5. Total Days in the Neonatal Intensive Care Unit [participants will be followed for the duration of hospital stay, up to 17 weeks after delivery]

   Number of days a baby spends in the neonatal intensive care unit

6. Duration of Ventilator Support [participants will be followed for the duration of hospital stay, up to 17 weeks after delivery]

   Number of days a baby requires use of mechanical ventilation

7. Retinopathy of Prematurity Requiring Treatment [participants will be followed for the duration of hospital stay, up to 17 weeks after delivery]

   Number of newborn with Retinopathy of Prematurity that requires intervention.

8. Birthweight < 1500 Grams [at time of birth, expected to be within 4 weeks of due date]

   Number of newborns whose birthweight is less than 1500 grams

9. Birthweight < 2500 Grams [at time of birth, expected to be within 4 weeks of due date]

   Number of newborns whose birthweight is less than 2500 grams

10. Gestational Age at Delivery [at time of birth, expected to be within 4 weeks of due date]

    Number of weeks of gestation completed by time of delivery

11. Use of Tocolysis [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants required use of tocolytic medication

12. Use of Antenatal Steroids [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery

13. Chorioamnionitis [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.

14. Vaginal Bleeding [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who experienced bleeding from lower genital tract during antepartum period

15. Preterm Premature Rupture of Membranes [participants will be followed for the duration of pregnancy, up to nine months]

    Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.

16. Cesarean Delivery [at time of delivery, expected to be within 4 weeks of due date]

    Number of participants that underwent cesarean delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
2	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Gene Lee, MD
• Medical University of South Carolina

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 4, 2019

More Information

Publications

• Arabin B, Halbesma JR, Vork F, Hübener 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.
• Carreras E, Arévalo S, Bello-Muñoz JC, Goya M, Rodó 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.
• Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, Juan M, Rodríguez A, Muñoz B, Santacruz B, Bello-Muñoz 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.
• 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.
• 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.
• 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. German.
• Sieroszewski P, Jasiński 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.
• 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.

• Responsible Party: Gene Lee, MD, Assistant Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT02357394
• Other Study ID Numbers: KUOBGYN001
• First Posted: Feb 6, 2015
• Last Update Posted: Oct 31, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Gene Lee, MD, Assistant Professor, University of Kansas Medical Center: arabin pessary; short cervix
• Additional relevant MeSH terms: Premature Birth

Study Results

Participant Flow

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	4	3
COMPLETED	4	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Device: Arabin Pessary	Standard of Care	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	4	3	7
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	37.2	36	36.7
Sex: Female, Male (Count of Participants)
Female	4 100%	3 100%	7 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 25%	0 0%	1 14.3%
White	3 75%	3 100%	6 85.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	3 100%	7 100%
marital status (Count of Participants)
married or living with partner	3 75%	3 100%	6 85.7%
never married	1 25%	0 0%	1 14.3%
employment status (Count of Participants)
full time	2 50%	3 100%	5 71.4%
unemployed	1 25%	0 0%	1 14.3%
part-time	1 25%	0 0%	1 14.3%
years education (years) [Mean (Full Range) ]
Mean (Full Range) [years]	14.5	14	14.4
insurance group (Count of Participants)
private insurance	4 100%	3 100%	7 100%
uninsured	0 0%	0 0%	0 0%
government insurance	0 0%	0 0%	0 0%
tobacco use (Count of Participants)
Count of Participants [Participants]	1 25%	0 0%	1 14.3%
alcohol use (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
prepreg BMI (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	22.4	36.4	28.4
infections before enrollment (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
infections at enrollment (Count of Participants)
Count of Participants [Participants]	1 25%	0 0%	1 14.3%
nullipara (Count of Participants)
Count of Participants [Participants]	0 0%	1 33.3%	1 14.3%
# of pregnancies < 16 wk delivered spontaneously (pregnancies) [Mean (Full Range) ]
Mean (Full Range) [pregnancies]	0.25	1	0.6
# of pregnancies 16w0d-23w6d delivered spontaneously (pregnancies) [Mean (Full Range) ]
Mean (Full Range) [pregnancies]	0	0	0
# of pregnancies 24w0d-36w6d delivered sponaneously (pregnancies) [Mean (Full Range) ]
Mean (Full Range) [pregnancies]	0	0	0
prior operative vaginal delivery (Count of Participants)
yes	1 25%	0 0%	1 14.3%
no	3 75%	3 100%	6 85.7%
prior Cesarean (Count of Participants)
yes	1 25%	0 0%	1 14.3%
no	3 75%	3 100%	6 85.7%
prior cervical surgery (Count of Participants)
yes	0 0%	0 0%	0 0%
no	4 100%	3 100%	7 100%
gestational weeks at randomization (weeks) [Mean (Full Range) ]
Mean (Full Range) [weeks]	21.4	19.6	20.7
TVCL at randomization (millimeters) [Mean (Full Range) ]
Mean (Full Range) [millimeters]	15.8	20.2	17.7
Funneling present (Count of Participants)
Count of Participants [Participants]	4 100%	2 66.7%	6 85.7%
sludge present (Count of Participants)
Count of Participants [Participants]	2 50%	0 0%	2 28.6%
progesterone started? (Count of Participants)
Count of Participants [Participants]	0 0%	2 66.7%	2 28.6%
cerclage placed? (Count of Participants)
Count of Participants [Participants]	0 0%	1 33.3%	1 14.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	3 75%	1 33.3%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	1 25%	0 0%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	1 25%	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	3	3
Mean (Full Range) [days]	3.3	7

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	3	3
Count of Participants [Participants]	0 0%	1 33.3%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	3	3
Mean (Full Range) [days]	0	16

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	3	3
Mean (Full Range) [days]	0	0

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	3	3
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	1 25%	0 0%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	3 75%	1 33.3%

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Mean (Full Range) [weeks]	33.1	37.3

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	0 0%	0 0%

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	0 0%	3 100%

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	0 0%	0 0%

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	1 25%	0 0%

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	1 25%	1 33.3%

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: Arabin Pessary	Standard of Care
Arm/Group Description	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.	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.
Measure Participants	4	3
Count of Participants [Participants]	1 25%	0 0%

Adverse Events

Time Frame	1 year, 5 months
Arm/Group Title	Device: Arabin Pessary		Standard of Care
Arm/Group Description	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.		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.
All Cause Mortality
	Device: Arabin Pessary		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)
Serious Adverse Events
	Device: Arabin Pessary		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Device: Arabin Pessary		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)

Limitations/Caveats

Study closed due to poor enrollment, unable to complete.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.