Clinical trial NCT01380158: Preventing Preterm Birth With a Pessary
Official title: Preventing Preterm Birth With a Pessary
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preterm Birth
Keywords: pessary
preterm birth
short cervix
cervical incompetence
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
* Women ages 18 to 45 years of age

Exclusion Criteria:

* Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
* Presence of prophylactic cervical cerclage
* Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
* Painful regular uterine contractions, or ruptured membranes
* Visual cervical dilation of 2cm or greater and visible membranes.
* Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.

Primary outcomes:
measure: delivery prior to 37 weeks of gestation
timeFrame: within the first 30 days after delivery of the neonate
Secondary outcomes:
measure: Rate of birth less than seven days from randomization
timeFrame: within the first 30 days after delivery of the neonate
measure: Previable birth (<24 weeks)
timeFrame: within the first 30 days after delivery of the neonate
measure: Perinatal death
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Low birth weight
timeFrame: within the first 30 days after delivery of the neonate
measure: Major adverse neonatal outcomes
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Need for neonatal special care
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Incidence of complications due to pessary
timeFrame: Every 4 weeks while pregnant with pessary in situ
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
Study officials:
affiliation: Medstar Health Research Institute
name: Rita W Driggers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
citation: Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015.
citation: Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.
citation: Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. doi: 10.1097/00006250-196805000-00024. No abstract available.
citation: Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. doi: 10.1097/00003081-196608000-00011. No abstract available.
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: Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachow J. [Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery]. Ginekol Pol. 2003 Oct;74(10):1029-36. Polish.