NCT01380158

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

February 17, 2021

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

June 15, 2011

Last Update Submit

February 15, 2021

Conditions

Preterm Birth

Keywords

pessarypreterm birthshort cervixcervical incompetence

Outcome Measures

Primary Outcomes (1)

  • delivery prior to 37 weeks of gestation

    Gestational age at birth will be recorded

    within the first 30 days after delivery of the neonate

Secondary Outcomes (7)

  • Rate of birth less than seven days from randomization

    within the first 30 days after delivery of the neonate

  • Previable birth (<24 weeks)

    within the first 30 days after delivery of the neonate

  • Perinatal death

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Low birth weight

    within the first 30 days after delivery of the neonate

  • Major adverse neonatal outcomes

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Pessary use during pregnancy

EXPERIMENTAL

Device: Cup pessary

Device: Cup pessary (Bioteque America, Inc)

Expectant management

NO INTERVENTION

Expectant Management + weekly intramuscular progesterone injections

Interventions

Cup pessary (Bioteque America, Inc)DEVICE

Placement of cup pessary in the vagina after randomization

Pessary use during pregnancy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Franklin Square Hospital

Baltimore, Maryland, 21237, United States

Location

Related Publications (7)

  • 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.

    PMID: 8569824BACKGROUND

  • 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.

    PMID: 19788970BACKGROUND

  • 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.

    PMID: 12802023BACKGROUND

  • 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.

    PMID: 5646408BACKGROUND

  • 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.

    PMID: 5944837BACKGROUND

  • 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: 12747228BACKGROUND

  • 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.

    PMID: 14669390BACKGROUND

MeSH Terms

Conditions

Premature BirthUterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesAbortion, HabitualAbortion, SpontaneousGenital Diseases

Study Officials

  • Rita W Driggers, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 27, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Last Updated

February 17, 2021

Record last verified: 2011-06

Locations

US(3)