Multifactorial Approach to Emergent Cerclage (RECIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01114516
First received: April 29, 2010
Last updated: April 30, 2010
Last verified: April 2010

April 29, 2010
April 30, 2010
March 2010
July 2011   (final data collection date for primary outcome measure)
Gestational latency achieved between cerclage placement and time of delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01114516 on ClinicalTrials.gov Archive Site
  • Gestational age at delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Neonatal morbidity and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    NICU days, birthweight
Same as current
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: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
53
July 2011
July 2011   (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
Female
18 Years to 80 Years
No
Not Provided
United States
 
NCT01114516
STU00019610
No
Linda Fonseca/Principal Investigator, Northwestern University
Northwestern University
Not Provided
Not Provided
Northwestern University
April 2010

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