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Completed

NCT Number: NCT02372422

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.

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Key information

Conditions

Pregnancy Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasound determination of cervical length

Other

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 care

Other

Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.

Primary outcomes

  1. Gestational age at delivery

    Time frame: Immediately at the time of delivery

    Gestational age reported as completed weeks of gestation

Secondary outcomes

  1. Preterm birth at < 35 completed weeks of gestation

    Time frame: Immediately at the time of delivery

    The proportion of women delivering preterm at less than 35 completed weeks of gestation.

  2. Number of days of maternal bed rest

    Time frame: Immediately at the time of delivery

    The number of days a woman was instructed to remain at bed rest or home rest before delivery

  3. Number of maternal days in the hospital

    Time frame: Immediately at the time of delivery

    The number of antenatal hospital days not including the postpartum stay

  4. Use of tocolytic medications

    Time frame: Immediately at the time of delivery

    Any use of tocolytic medications prior to delivery

  5. Administration of steroids

    Time frame: Immediately at the time of delivery

    Any use of steroids for the promotion of fetal lung maturity

  6. Birth weight

    Time frame: Immediately at the time of delivery

    Newborn birth weight

  7. Length of stay in the neonatal intensive care unit

    Time frame: Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks

    Total days spent in the neonatal intensive care unit

  8. Severe neonatal morbidity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Fed

Collaborators

  • Madigan Army Medical Center
  • Wright-Patterson Medical Center

Registry information

Official study title

Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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