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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
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 prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.
Gestational age at delivery
Gestational age reported as completed weeks of gestation
Time frame: Immediately at the time of delivery
Preterm birth at < 35 completed weeks of gestation
The proportion of women delivering preterm at less than 35 completed weeks of gestation.
Time frame: 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
Time frame: Immediately at the time of delivery
Number of maternal days in the hospital
The number of antenatal hospital days not including the postpartum stay
Time frame: Immediately at the time of delivery
Use of tocolytic medications
Any use of tocolytic medications prior to delivery
Time frame: Immediately at the time of delivery
Administration of steroids
Any use of steroids for the promotion of fetal lung maturity
Time frame: Immediately at the time of delivery
Birth weight
Newborn birth weight
Time frame: Immediately at the time of delivery
Length of stay in the neonatal intensive care unit
Total days spent in the neonatal intensive care unit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks