Pregnancy
Conditions
Keywords
Twins, Twin gestation, Preterm birth, Prevention
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.
Interventions
OTHERTransvaginal 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.
OTHERRoutine care
Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.
Sponsors
Madigan Army Medical Center
Wright-Patterson Medical Center
William H. Barth, Jr., M.D., Col(ret), USAF, MC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at delivery | Immediately at the time of delivery | Gestational age reported as completed weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days of maternal bed rest | Immediately at the time of delivery | The number of days a woman was instructed to remain at bed rest or home rest before delivery |
| Number of maternal days in the hospital | Immediately at the time of delivery | The number of antenatal hospital days not including the postpartum stay |
| Use of tocolytic medications | Immediately at the time of delivery | Any use of tocolytic medications prior to delivery |
| Preterm birth at < 35 completed weeks of gestation | Immediately at the time of delivery | The proportion of women delivering preterm at less than 35 completed weeks of gestation. |
| Birth weight | Immediately at the time of delivery | Newborn birth weight |
| Length of stay in the neonatal intensive care unit | Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks | Total days spent in the neonatal intensive care unit |
| Severe neonatal morbidity | Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks | 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 |
| Administration of steroids | Immediately at the time of delivery | Any use of steroids for the promotion of fetal lung maturity |
Outcome results
None listed