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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02357394
• Other study ID #: KUOBGYN001
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 1, 2019
• Est. primary completion date: June 6, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gene Lee, MD	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. German. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 37 weeks 0 days
Secondary	Preterm Birth Before 34 Weeks	Number of deliveries before 34 weeks 0 days of gestation	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	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	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.	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	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	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.	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	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	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	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	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	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.	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	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.	participants will be followed for the duration of pregnancy, up to nine months
Secondary	Cesarean Delivery	Number of participants that underwent cesarean delivery	at time of delivery, expected to be within 4 weeks of due date