PregnancyNCT02372422
Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
A study testing Transvaginal ultrasound determination of cervical length and Routine care in people with Pregnancy, run by William H. Barth, Jr., M.D., Col(ret), USAF, MC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Transvaginal ultrasound determination of cervical length and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Twin pregnancy
- Gestational age < 20 weeks
Who cannot join
- 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
About this study
Official title: Use of 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Transvaginal ultrasound determination of cervical length, Routine care
- Keywords
- Twins, Twin gestation, Preterm birth, Prevention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound determination of cervical lengthOther
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 careOther
Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Cervical Length Group | Experimental | Clinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements. Receives: Other: Transvaginal ultrasound determination of cervical length |
| Routine Care | Other | Clinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery
Gestational age reported as completed weeks of gestation
Measured: Immediately at the time of delivery
Secondary outcomes (8)
Preterm birth at < 35 completed weeks of gestation
The proportion of women delivering preterm at less than 35 completed weeks of gestation.
Measured: 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
Measured: Immediately at the time of delivery
Number of maternal days in the hospital
The number of antenatal hospital days not including the postpartum stay
Measured: Immediately at the time of delivery
Use of tocolytic medications
Any use of tocolytic medications prior to delivery
Measured: Immediately at the time of delivery
Administration of steroids
Any use of steroids for the promotion of fetal lung maturity
Measured: Immediately at the time of delivery
Birth weight
Newborn birth weight
Measured: Immediately at the time of delivery
Length of stay in the neonatal intensive care unit
Total days spent in the neonatal intensive care unit
Measured: 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
Measured: Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startOct 2002
- Primary completionJun 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- William H. Barth, Jr., M.D., Col(ret), USAF, MC
- Sponsor type
- US federal agency
- Collaborators
- Madigan Army Medical Center, Wright-Patterson Medical Center
- Responsible party
- Sponsor-investigator, William H. Barth, Jr., M.D., Col(ret), USAF, MC, 59th Medical Wing
- Investigators
- Michael C Gordon, M.D., Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372422
- Sponsor's protocol ID
- FWH20020099H
- Status last verified
- Feb 2015
- First submitted
- 15 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
- ClinicalTrials.gov ID
- NCT02372422
- Acronym / sponsor ID
- FWH20020099H
- Conditions
- Pregnancy
- Keywords
- Twins, Twin gestation, Preterm birth, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- William H. Barth, Jr., M.D., Col(ret), USAF, MCUS federal agency
- Collaborators
- Madigan Army Medical Center, Wright-Patterson Medical Center
- Study start
- Oct 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Cervical Length Group | Experimental | Other: Transvaginal ultrasound determination of cervical lengthClinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements. |
| Routine Care | Other | Other: Routine careClinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Twin pregnancy
- Gestational age < 20 weeks
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasound determination of cervical lengthTransvaginal 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. | Other | Transvaginal Cervical Length Group |
| Routine careRoutine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not. | Other | Routine Care |
Primary outcome
Gestational age at delivery
Time frame: Immediately at the time of delivery
Gestational age reported as completed weeks of gestation
8 secondary outcomes
Preterm birth at < 35 completed weeks of gestation
Time frame: Immediately at the time of delivery
Number of days of maternal bed rest
Time frame: Immediately at the time of delivery
Number of maternal days in the hospital
Time frame: Immediately at the time of delivery
Use of tocolytic medications
Time frame: Immediately at the time of delivery
Administration of steroids
Time frame: Immediately at the time of delivery
Birth weight
Time frame: Immediately at the time of delivery
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
Severe neonatal morbidity
Time frame: Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Gordon, M.D. principal investigator
59th Medical Wing
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound determination of cervical length and Routine care in people with Pregnancy, run by William H. Barth, Jr., M.D., Col(ret), USAF, MC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at delivery (time frame: Immediately at the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.