Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Transvaginal ultrasound determination of cervical length; Other: Routine care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transvaginal Cervical Length Group; Clinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements.	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.
OTHER: Routine Care; Clinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements.	Other: Routine care; Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery	Gestational age reported as completed weeks of gestation	Immediately at the time of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of maternal days in the hospital	The number of antenatal hospital days not including the postpartum stay	Immediately at the time of delivery
Use of tocolytic medications	Any use of tocolytic medications prior to delivery	Immediately at the time of delivery
Administration of steroids	Any use of steroids for the promotion of fetal lung maturity	Immediately at the time of delivery
Birth weight	Newborn birth weight	Immediately at the time of delivery
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
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

Collaborators and Investigators

• Sponsor: William H. Barth, Jr., M.D., Col(ret), USAF, MC
• Collaborators: Madigan Army Medical Center; Wright-Patterson Medical Center
• Investigators: Principal Investigator: Michael C Gordon, M.D., 59th Medical Wing

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (ACTUAL): June 1, 2006
• Study Completion (ACTUAL): July 1, 2007

Study Registration Dates

• First Submitted: February 15, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (ESTIMATE): February 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Prevention; Preterm birth; Twins; Twin gestation
• Other Study ID Numbers: FWH20020099H