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

NCT02357394 | Terminated Results DMC FDA Device

• 1 other identifier: KUOBGYN001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Birth

Keywords

arabin pessary; short cervix

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Preterm Birth Before 34 Weeks

  up to 34 weeks 0 days

• Neonatal Composite Morbidity

  antepartum and up to 28 days after postnatal gestational age of 36 weeks

• Neonatal Length of Stay

  participants will be followed for the duration of hospital stay, up to 17 weeks after delivery

• Admission to Neonatal Intensive Care Unit

  participants will be followed for the duration of hospital stay, up to 17 weeks after delivery

• Total Days in the Neonatal Intensive Care Unit

  participants will be followed for the duration of hospital stay, up to 17 weeks after delivery

Study Arms (2)

Device: Arabin Pessary

EXPERIMENTAL

Participants randomized to this group will receive the pessary.

Device: Arabin 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.

Interventions

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.

Device: Arabin Pessary

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• singleton
• cervical length \< 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
• agrees to refrain from sexual intercourse

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gene Lee, MD: lead
• Medical University of South Carolina: collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (8)

• 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.

  PMID: 23055333 BACKGROUND

• 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.

  PMID: 22475493 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.

  PMID: 22871155 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.

  PMID: 19530009 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.

  PMID: 12747228 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.

  PMID: 2198191 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.

  PMID: 23924878 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.

  PMID: 24898103 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

Study closed due to poor enrollment, unable to complete.

Results Point of Contact

• Title: Dr. Gene Lee
• Organization: University of Kansas Health System, Dept of OBGYN

glee@kumc.edu

9135886201

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: February 6, 2015
• Study Start: May 1, 2015
• Primary Completion: June 6, 2017
• Study Completion: April 1, 2019
• Last Updated: October 31, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)