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Multifactorial Approach to Emergent Cerclage (RECIA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114516
First Posted: May 3, 2010
Last Update Posted: November 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Grobman, Northwestern University
April 29, 2010
May 3, 2010
September 8, 2014
October 10, 2014
November 7, 2014
March 2010
March 2013   (Final data collection date for primary outcome measure)
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery [ Time Frame: 24 weeks ]
Median gestational latency achieved Between Cerclage Placement and Time of Delivery
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT01114516 on ClinicalTrials.gov Archive Site
  • Gestational Latency of More Than 28 Days [ Time Frame: 28 days postpartum ]
    The frequency of achieving a gestational latency of more than 28 days
  • Gestational Age at Delivery [ Time Frame: 24 weeks ]
    Median gestational age at delivery
  • Neonatal Morbidity and Mortality [ Time Frame: 1 year ]
    Days spent in the neonatal intensive care unit
  • Birthweight [ Time Frame: 24 weeks ]
    Median birthweight
  • Gestational Age at Delivery [ Time Frame: 24 weeks ]
  • Neonatal Morbidity and Mortality [ Time Frame: 1 year ]
    NICU days, birthweight
Not Provided
Not Provided
 
Multifactorial Approach to Emergent Cerclage
Role in Emergent Cerclage of Indomethacin and Antibiotics

Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.

The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cervical Insufficiency
Drug: Indomethacin and antibiotics (cefazolin or clindamycin)
q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
Other Name: indocin, cleocin, ancef
  • No Intervention: control
    emergent cerclage with no peri-operative antibiotics or indomethacin
  • Experimental: indomethacin and antibiotics
    perioperative antibiotics and indomethacin
    Intervention: Drug: Indomethacin and antibiotics (cefazolin or clindamycin)
Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-6. doi: 10.1097/AOG.0000000000000228.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2014
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • GA 16+0 to 23+6 weeks
  • Singleton gestation
  • Presence of cervical dilation as diagnosed on digital examination
  • Intact membranes

Exclusion Criteria:

  • Age <18 years
  • Allergy to NSAIDs
  • Renal disease
  • Allergy to penicillins AND clindamycin
  • Currently on antibiotics or indomethacin for any reason
  • HIV positive
  • Pregnancies complicated by fetal congenital anomalies
  • Preterm premature rupture of membranes
  • Fever of 100.4 degrees Fahrenheit or higher
  • Any patient having received a therapeutic cerclage during the current pregnancy
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01114516
STU00019610
No
Not Provided
Not Provided
William Grobman, Northwestern University
Northwestern University
Not Provided
Not Provided
Northwestern University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP