Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

Pregnancy Clinical Trial

Official title:

Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372422
• Other study ID #: FWH20020099H
• Status: Completed
• Phase: N/A
• First received: February 15, 2015
• Last updated: February 20, 2015
• Start date: October 2002
• Est. completion date: July 2007

Study information

• Verified date: February 2015
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the use of routine transvaginal cervical length ultrasound can be used to prevent preterm deliveries in twin gestations.

Description:

This is a randomized controlled trial to determine whether there is a difference in the rate of preterm birth among women with twin pregnancies whose clinicians are aware of transvaginal ultrasound cervical length measurements compared to those managed without this information. The study group had transvaginal cervical length ultrasound monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage depending on the cervical length. The control group had digital cervical exams and routine transvaginal cervical length ultrasound was not utilized. The primary outcome was the mean length of gestation. Secondary outcomes included percentage of deliveries < 35 weeks, maternal and neonatal outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Twin pregnancy

• Gestational age < 20 weeks

Exclusion Criteria:

• History of incompetent cervix with plans to place a cerclage

• History of possible cervical incompetence with preexisting plans to monitor cervical length

• Prior preterm birth at < 28 weeks gestational age

• Plans to leave the area before delivery

• Known major fetal anomaly

• Known diagnosis of twin-twin transfusion syndrome

• Age < 18

• Monoamniotic twins

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Transvaginal ultrasound determination of cervical length
Transvaginal ultrasound was used to measure the length of the cervix from the internal to external os relying on a standard approach and clinicians caring for the patients were made aware of the results.
• Routine care
Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
William H. Barth, Jr., M.D., Col(ret), USAF, MC	Madigan Army Medical Center, Wright-Patterson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at delivery	Gestational age reported as completed weeks of gestation	Immediately at the time of delivery	No
Secondary	Preterm birth at < 35 completed weeks of gestation	The proportion of women delivering preterm at less than 35 completed weeks of gestation.	Immediately at the time of delivery	No
Secondary	Number of days of maternal bed rest	The number of days a woman was instructed to remain at bed rest or home rest before delivery	Immediately at the time of delivery	No
Secondary	Number of maternal days in the hospital	The number of antenatal hospital days not including the postpartum stay	Immediately at the time of delivery	No
Secondary	Use of tocolytic medications	Any use of tocolytic medications prior to delivery	Immediately at the time of delivery	No
Secondary	Administration of steroids	Any use of steroids for the promotion of fetal lung maturity	Immediately at the time of delivery	No
Secondary	Birth weight	Newborn birth weight	Immediately at the time of delivery	No
Secondary	Length of stay in the neonatal intensive care unit	Total days spent in the neonatal intensive care unit	Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks	No
Secondary	Severe neonatal morbidity	Composite outcome defined as one or more of the following: neonatal death, mechanical ventilation after 72 hours of life, chronic lung disease, grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia, necrotizing enterocolitis, stage 3 or higher retinopathy of prematurity, culture proven sepsis, or hemodynamic instability requiring pressor medications after 72 hours of life	Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks	No