Clinical trial NCT02357394: Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
Official title: Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Keywords: arabin pessary
short cervix
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2015-02-06
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Preterm Birth Before 37 Weeks
timeFrame: Up to 37 weeks 0 days
Secondary outcomes:
measure: Preterm Birth Before 34 Weeks
timeFrame: up to 34 weeks 0 days
measure: Neonatal Composite Morbidity
timeFrame: antepartum and up to 28 days after postnatal gestational age of 36 weeks
measure: Neonatal Length of Stay
timeFrame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
measure: Admission to Neonatal Intensive Care Unit
timeFrame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
measure: Total Days in the Neonatal Intensive Care Unit
timeFrame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
measure: Duration of Ventilator Support
timeFrame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
measure: Retinopathy of Prematurity Requiring Treatment
timeFrame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
measure: Birthweight < 1500 Grams
timeFrame: at time of birth, expected to be within 4 weeks of due date
measure: Birthweight < 2500 Grams
timeFrame: at time of birth, expected to be within 4 weeks of due date
measure: Gestational Age at Delivery
timeFrame: at time of birth, expected to be within 4 weeks of due date
measure: Use of Tocolysis
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Use of Antenatal Steroids
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Chorioamnionitis
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Vaginal Bleeding
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Preterm Premature Rupture of Membranes
timeFrame: participants will be followed for the duration of pregnancy, up to nine months
measure: Cesarean Delivery
timeFrame: at time of delivery, expected to be within 4 weeks of due date
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Kansas Medical Center
name: Gene T Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Eugene Y Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Carl P Weiner, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.
citation: 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.
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. doi: 10.1055/s-2008-1026276. German.
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.
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.