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

Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Premature Birth
• Intervention / Treatment: Device: Arabin Pessary

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Tocolysis	Number of participants required use of tocolytic medication	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
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	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 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
Cesarean Delivery	Number of participants that underwent cesarean delivery	at time of delivery, expected to be within 4 weeks of due date

Collaborators and Investigators

• Sponsor: Gene Lee, MD
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 6, 2017
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: short cervix; arabin pessary
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: KUOBGYN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participating in GoNet IPD of pessary for prevention of preterm birth.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes