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OpenTrials
Completed

NCT Number: NCT01114516

Multifactorial Approach to Emergent Cerclage

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.

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Key information

Conditions

Cervical Insufficiency Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pregnancy Complications Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Incompetence Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: indocin, cleocin, ancef

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Role in Emergent Cerclage of Indomethacin and Antibiotics

Acronym: RECIA

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 3, 2010
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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