Short Cervix - Twins

Short Cervix Clinical Trial

Official title:

Management of Twins With Short Cervix at a Single Institution: A Retrospective Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022591
• Other study ID #: 27027
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: February 8, 2018
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective chart review. The purpose of this study will be to look at the outcomes of twin pregnancies diagnosed with short cervix along with the intervention (treatment) that these patients received.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

Inclusion Criteria:

• Charts of all women who had twins and a short cervix will be reviewed,

Exclusion Criteria:

• singleton

Related Conditions & MeSH terms

• Short Cervix

Intervention

Other:
• Management
management of twin pregnancies with a short cervix diagnosed between 16 0/7 WGA to 27 6/7 WGA.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short cervix	management decisions and outcomes of twin pregnancies diagnosed with short cervix.	1 year