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Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls: AVERT PRETERM TRIAL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03151330
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : July 13, 2022
Information provided by (Responsible Party):
Matthew Hoffman, Christiana Care Health Services

Brief Summary:

Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Nonetheless, the majority of women who are at risk are not identified using current screening modalities.

Hypothesis: A cohort of pregnancies who are screened using the PreTRM® test around 20 weeks gestation in which a bundle of interventions is given for elevated PreTRM® risk will show either decreased neonatal morbidity/and mortality (measured as a composite score, "NMI"), or decreased length of neonatal stay in the hospital (NNOLOS). Secondarily, they will show an increase in gestational age at birth (GAB) and a reduction in length of neonatal NICU stay (NICULOS), compared to an unscreened historical control group.

Study Design Type: Prospective cohort study of screened women compared to a historical control of 10000 women.

Condition or disease Intervention/treatment Phase
Preterm Birth Other: Screened Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Women who are found to have an elevated risk of preterm birth will receive counseling regarding potential interventions and compared to historical controls
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : March 16, 2020
Estimated Study Completion Date : November 1, 2023

Arm Intervention/treatment
Screened arm
This will be an arm of women who are prospectively screened and receive a risk score for preterm birth. They will be recommended treatment strategies and their outcomes compared to an historical control.
Other: Screened Arm
Woman who are identified as high risk will be advised of potential interventions which will include support through care link(nurse education), cervical surveillance, consider vaginal progesterone, low dose aspirin if not already taking.

Primary Outcome Measures :
  1. Neonatal Mortality Index [ Time Frame: Birth through 6 months ]


    Co primary outcomes will consist of the Neonatal Morbidity Index as defined by Hassan and Neonatal NICU length of stay

  2. Neonatal NICU length of stay [ Time Frame: Birth to 6 months ]
    Duration of hospitalization in the NICU

Secondary Outcome Measures :
  1. Preterm birth [ Time Frame: Through pregnancy completion, typically 42 weeks ]
    Preterm birth before 37 weeks

  2. Total length of hospital stay for any preterm birth [ Time Frame: From birth to 60 days post delivery ]
    Total length of hospital stay for any preterm birth

Other Outcome Measures:
  1. Neonatal death and stillbirth [ Time Frame: Through 42 days post delivery ]
    Neonatal death and stillbirth

  2. Birthweight and if birthweight was <1500g [ Time Frame: At time of delivery ]
    birthweight below 1500 and 2500gm

  3. Birthweight and if birthweight was <2500gm [ Time Frame: At time of delivery ]
    birthweight below 2500gm

  4. Whether or not received surfactant and amount of surfactant [ Time Frame: Through hospitalization or 60 days post delivery ]
    Whether baby got surfactant

  5. Occurrence of pneumonia [ Time Frame: Through hospitalization or 60 days post delivery ]
    Occurrence of pneumonia

  6. Number of days of mechanical ventilation [ Time Frame: Through hospitalization or 60 days post delivery ]
    days on mechanical ventilation

  7. Occurrence of 5 minute Apgar<7 [ Time Frame: At time of birth ]
    low apgar as defined

  8. Occurrence of asphyxia, diagnosed either via intrapartum cord gas or via clinical findings [ Time Frame: At tiem of birth ]
    Occurrence of asphyxia,

  9. Occurrence of preterm delivery at <37, <35 and <32 weeks [ Time Frame: At time of birth ]
    Occurrence of preterm delivery at <37, <35 and <32 weeks

  10. Occurrence of preeclampsia [ Time Frame: Through 60 days post delivery ]
    preeclampsia as defined by ACOG

  11. Progesterone levels determined by LC-MS [ Time Frame: at 32 weeks ]
    progesterone levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   requires pregnancy
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Women 18 years of age or older
  • Singleton intrauterine pregnancy
  • No medical contraindications to continuing pregnancy
  • Subject has no signs and/or symptoms of preterm labor and has intact membranes
  • Planned delivery at Christiana Care Health System,
  • English speaking as consents from other languages will not be provided.

Exclusion Criteria:

  • Women who have taken or plan to take progesterone beyond 14weeks gestation prior to study enrollment
  • Previous history of sPTB less than37 weeks gestation or PPROM less than34 weeks gestation
  • Multiple gestations-including a pregnancy that is now a single fetus due to a reduction procedure, vanishing twin, etc
  • Known fetal genetic anomalies that are incompatible with life. Examples would include trisomy 13 and trisomy 18. Others would be left to the discretion of the site investigators
  • Any other medical conditions that may be considered a contraindication per the judgment of the site investigator
  • The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
  • The subject has a planned cerclage placement for the current pregnancy
  • Major structural anomalies that may shorten pregnancy- examples would include anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia, pyloric stenosis, etc. Minor anomalies such as polydactyly, unilateral hydronephrosis are not viewed as exclusions. Others would be left to the discretion of the site investigators
  • History of cervical conization
  • The subject has a uterine anomaly, History of classical cesarean section in a previous pregnancy
  • The subject has had a blood transfusion during the current pregnancy
  • The subject has known elevated bilirubin levels (hyperbilirubinemia)
  • Previously identified short cervix (< 2.5 cm by TVUS)
  • The subject has taken or plans to take any of the following medications after the first day of the last menstrual period: Enoxaparin, heparin, heparin sodium, low molecular weight heparin or the subject has a history of allergic reaction to aspirin or progesterone.

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): NCT03151330

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United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
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Principal Investigator: Matthew K Hoffman, MD ChristianaCare
  Study Documents (Full-Text)

Documents provided by Matthew Hoffman, Christiana Care Health Services:
Statistical Analysis Plan  [PDF] July 11, 2022


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Responsible Party: Matthew Hoffman, Chair Department of OB/GYN, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT03151330    
Other Study ID Numbers: DDD603819
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will potentially be shared with a like study being conducted at the University of Utah

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases