Multifactorial Approach to Emergent Cerclage

Cervical Insufficiency Clinical Trial

— RECIA  

Official title:

Role in Emergent Cerclage of Indomethacin and Antibiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114516
• Other study ID #: STU00019610
• Status: Completed
• Phase: N/A
• First received: April 29, 2010
• Last updated: November 5, 2014
• Start date: March 2010
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Insufficiency
• Uterine Cervical Incompetence

Intervention

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

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Latency Achieved Between Cerclage Placement and Time of Delivery	Median gestational latency achieved Between Cerclage Placement and Time of Delivery	24 weeks	No
Secondary	Gestational Latency of More Than 28 Days	The frequency of achieving a gestational latency of more than 28 days	28 days postpartum	No
Secondary	Gestational Age at Delivery	Median gestational age at delivery	24 weeks	No
Secondary	Neonatal Morbidity and Mortality	Days spent in the neonatal intensive care unit	1 year	No
Secondary	Birthweight	Median birthweight	24 weeks	No