- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022591
Short Cervix - Twins
Management of Twins With Short Cervix at a Single Institution: A Retrospective Review
Study Overview
Detailed Description
In 2010, the incidence of preterm birth in twin gestations was 23% before 34 weeks and 58% before 37 weeks, while the overall incidence of PTB in all pregnancies was only 3.41% and 11.5%, respectively. Twin gestations are also at increased risk of being low birth weight infants.
Goldenberg et al demonstrated in 1996 that a cervical length less than 25 mm at 24 weeks gestation in twin pregnancies was the best predictor of preterm birth at <32 weeks, <35 weeks, and < 37 weeks. In 1999, Souka et al reported that in twin pregnancies with a cervical length less than 15 mm at 23 weeks gestation, the preterm birth rate <32 weeks was approximately 66%.
A Cochrane Review from 2014 concluded that placing a cerclage is not associated with a significant difference regarding perinatal deaths or neonatal morbidity, but this analysis was for all forms of cerclage in multiple gestations (physical examination-indicated, history-indicated, and ultrasound-indicated). It did also state "ultrasound-indicated cerclage appears to be associated with an increased risk for the composite adverse neonatal outcome, including respiratory distress syndrome, low and very low birthweight, given there is no evidence of a consistent subgroup effect, the observed results can most likely be attributed to chance."
In a 2015 retrospective cohort study of twin pregnancies with asymptomatic short cervix, Amanda Roman et al demonstrate similar results to those of the Cochrane Review for patients with CL <25 mm. However, they did show a trend towards prolonged pregnancy, decreased spontaneous PTB <34 weeks, and fewer NICU admissions for a subset of patients with CL < 15 mm that received a cerclage compared to control.
In February 2016, Goya et al investigated the role of the pessary for women with twin gestations and short cervix diagnosed via ultrasound. A significant reduction in the rate of preterm birth prior to 34 weeks was found in the pessary group (16.2% vs 39.4%), with no significant differences in neonatal morbidity or mortality.
Chart review will collect information documented on the data collection sheet, including medical and OB history, current pregnancy course, treatment for short cervix and information on hospitalization including labor and delivery, postpartum course and neonatal birth information.
The investigators will analyses and compare this group of women using short cervix diagnosis, management decisions and outcomes during the antepartum period, labor, delivery and post partum course for possible signs and symptoms of those at risk for Pre Term Birth and outcomes of their infants.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Charts of all women who had twins and a short cervix will be reviewed,
Exclusion Criteria:
- singleton
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short cervix
Time Frame: 1 year
|
management decisions and outcomes of twin pregnancies diagnosed with short cervix.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laure Vricella, MD, St. Louis University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 27027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Short Cervix
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St. Louis UniversityTerminated
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Juniper Pharmaceuticals, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPreterm Delivery | Short Cervix | Short Uterine Cervical LengthUnited States, Israel, Belarus, Chile, Czech Republic, India, Italy, Russian Federation, South Africa, Ukraine
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University of PennsylvaniaCompletedPremature Birth | Short CervixUnited States
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Université de SherbrookeCHU de Quebec-Universite Laval; Centre hospitalier de l'Université de Montréal... and other collaboratorsCompletedPreterm Birth | Short CervixCanada
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University of PennsylvaniaCompletedPreterm Birth | Short CervixUnited States
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Hillel Yaffe Medical CenterUnknown
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Galena Innovations, LLCNot yet recruitingPreterm Birth | Cervical Insufficiency | Short Cervix | Cervical Incompetence | Soft CervixUnited States
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The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPreterm Delivery | Short CervixUnited States
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