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Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

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ClinicalTrials.gov Identifier: NCT02372422
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Collaborators:
Madigan Army Medical Center
Wright-Patterson Medical Center
Information provided by (Responsible Party):
William H. Barth, Jr., M.D., Col(ret), USAF, MC, Wilford Hall Medical Center

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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Transvaginal ultrasound determination of cervical length Other: Routine care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
Study Start Date : October 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Transvaginal Cervical Length Group
Clinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements.
Other: Transvaginal 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.

Routine Care
Clinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements.
Other: Routine care
Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.




Primary Outcome Measures :
  1. Gestational age at delivery [ Time Frame: Immediately at the time of delivery ]
    Gestational age reported as completed weeks of gestation


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372422


Sponsors and Collaborators
William H. Barth, Jr., M.D., Col(ret), USAF, MC
Madigan Army Medical Center
Wright-Patterson Medical Center
Investigators
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Principal Investigator: Michael C Gordon, M.D. Wilford Hall Medical Center

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Responsible Party: William H. Barth, Jr., M.D., Col(ret), USAF, MC, Wilford Hall Medical Center
ClinicalTrials.gov Identifier: NCT02372422     History of Changes
Other Study ID Numbers: FWH20020099H
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by William H. Barth, Jr., M.D., Col(ret), USAF, MC, Wilford Hall Medical Center:
Twins
Twin gestation
Preterm birth
Prevention