Multifactorial Approach to Emergent Cerclage

Overview

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.

Full Title of Study: “Role in Emergent Cerclage of Indomethacin and Antibiotics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • No Intervention: control
    • emergent cerclage with no peri-operative antibiotics or indomethacin
  • Experimental: indomethacin and antibiotics
    • perioperative antibiotics and indomethacin

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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 Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: William Grobman, principal investigator – Northwestern University

Citations Reporting on Results

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.

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