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Multifactorial Approach to Emergent Cerclage (RECIA)

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. Identifier: NCT01114516
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : October 10, 2014
Last Update Posted : November 7, 2014
Information provided by (Responsible Party):
William Grobman, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Cervical Insufficiency Drug: Indomethacin and antibiotics (cefazolin or clindamycin) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role in Emergent Cerclage of Indomethacin and Antibiotics
Study Start Date : March 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2014

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Gestational Latency of More Than 28 Days [ Time Frame: 28 days postpartum ]
    The frequency of achieving a gestational latency of more than 28 days

  2. Gestational Age at Delivery [ Time Frame: 24 weeks ]
    Median gestational age at delivery

  3. Neonatal Morbidity and Mortality [ Time Frame: 1 year ]
    Days spent in the neonatal intensive care unit

  4. Birthweight [ Time Frame: 24 weeks ]
    Median birthweight

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114516

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United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University

Publications of Results:
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Responsible Party: William Grobman, principal investigator, Northwestern University Identifier: NCT01114516     History of Changes
Other Study ID Numbers: STU00019610
First Posted: May 3, 2010    Key Record Dates
Results First Posted: October 10, 2014
Last Update Posted: November 7, 2014
Last Verified: November 2014
Keywords provided by William Grobman, Northwestern University:
cervical insufficiency
Additional relevant MeSH terms:
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Clindamycin palmitate
Clindamycin phosphate
Uterine Cervical Incompetence
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents