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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 29, 2010
Last Updated Date	April 30, 2010
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 30, 2010)	Gestational latency achieved between cerclage placement and time of delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01114516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 30, 2010)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Multifactorial Approach to Emergent Cerclage
Official Title ^ICMJE	Role in Emergent Cerclage of Indomethacin and Antibiotics
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cervical Insufficiency
Intervention ^ICMJE	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
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	53
Estimated Completion Date	July 2011
Estimated Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01114516
Other Study ID Numbers ^ICMJE	STU00019610
Has Data Monitoring Committee	No
Responsible Party	Linda Fonseca/Principal Investigator, Northwestern University
Study Sponsor ^ICMJE	Northwestern University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Northwestern University
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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