Clinical trial NCT02372422: Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
Official title: Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Twins
Twin gestation
Preterm birth
Prevention
Lead sponsor: 59th Medical Wing
Sponsor class: FED
Collaborators: name: Madigan Army Medical Center
name: Wright-Patterson Medical Center
First posted: 2015-02-26
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gestational age at delivery
timeFrame: Immediately at the time of delivery
Secondary outcomes:
measure: Preterm birth at < 35 completed weeks of gestation
timeFrame: Immediately at the time of delivery
measure: Number of days of maternal bed rest
timeFrame: Immediately at the time of delivery
measure: Number of maternal days in the hospital
timeFrame: Immediately at the time of delivery
measure: Use of tocolytic medications
timeFrame: Immediately at the time of delivery
measure: Administration of steroids
timeFrame: Immediately at the time of delivery
measure: Birth weight
timeFrame: Immediately at the time of delivery
measure: Length of stay in the neonatal intensive care unit
timeFrame: Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks
measure: Severe neonatal morbidity
timeFrame: Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: 59th Medical Wing
name: Michael C Gordon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: