NCT01114516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 10, 2014

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

3 years

First QC Date

April 29, 2010

Results QC Date

September 8, 2014

Last Update Submit

November 5, 2014

Conditions

Cervical Insufficiency

Keywords

cervical insufficiency

Outcome Measures

Primary Outcomes (1)

  • Gestational Latency Achieved Between Cerclage Placement and Time of Delivery

    Median gestational latency achieved Between Cerclage Placement and Time of Delivery

    24 weeks

Secondary Outcomes (4)

  • Gestational Latency of More Than 28 Days

    28 days postpartum

  • Gestational Age at Delivery

    24 weeks

  • Neonatal Morbidity and Mortality

    1 year

  • Birthweight

    24 weeks

Study Arms (2)

control

NO INTERVENTION

emergent cerclage with no peri-operative antibiotics or indomethacin

indomethacin and antibiotics

EXPERIMENTAL

perioperative antibiotics and indomethacin

Drug: Indomethacin and antibiotics (cefazolin or clindamycin)

Interventions

Indomethacin and antibiotics (cefazolin or clindamycin)DRUG

q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin

Also known as: indocin, cleocin, ancef
indomethacin and antibiotics

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GA 16+0 to 23+6 weeks
  • Singleton gestation
  • Presence of cervical dilation as diagnosed on digital examination
  • Intact membranes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related 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):1311-1316. doi: 10.1097/AOG.0000000000000228.

    PMID: 24807330RESULT

MeSH Terms

Conditions

Uterine Cervical Incompetence

Interventions

IndomethacinAnti-Bacterial AgentsCefazolinClindamycin

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydrates

Limitations and Caveats

Because this study was not adequately powered to detect differences in perinatal outcomes, whether this adjunctive therapy affects these outcomes remains uncertain.

Results Point of Contact

Title
Dr. Emily Miller
Organization
Northwestern University Feinberg School of Medicine
emily-miller-1@northwestern.edu
3124724685

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 3, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

November 7, 2014

Results First Posted

October 10, 2014

Record last verified: 2014-11

Locations

US(1)