Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

William H. Barth, Jr., M.D., Col(ret), USAF, MC

Status: Completed

Conditions: Pregnancy

Treatments: Other: Routine care; Other: Transvaginal ultrasound determination of cervical length

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT02372422

FWH20020099H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

125 participants in 2 patient groups

Transvaginal Cervical Length Group

Experimental group

Description:

Clinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements.

Treatment:

Other: Transvaginal ultrasound determination of cervical length

Routine Care

Other group

Description:

Clinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements.

Treatment:

Other: Routine care