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

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ClinicalTrials.gov Identifier: NCT03151330
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : June 20, 2018
Sponsor:
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: Women who are screened using the PreTRM® test around 20 weeks gestation will have a -statistically significant reduction in preterm birth compared to an unscreened historical control group of preterm birth.

Study Design Type: Prospective cohort study of screened women compared to a historical control. The study will employ an adaptive design allowing periodic evaluation of the data to determine the optimal time to stop the study.


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

Detailed Description:

Population: Women who are 18 years or older, with a singleton pregnancy between 195/7 weeks and 206/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, and no history of prior preterm birth (delivery between 160/7 weeks and 366/7 weeks) will be invited to participate. A comparable population will be identified using a historical control group in a contemporaneously maintained database.

Intervention: Qualifying women will be screened using the PreTRM® test (Sera Prognostics, Inc.) at a large tertiary care center. Predicated upon the degree of risk, women will be treated according to a prespecified algorithm. The outcomes of these women will be compared to a historical control group at the same tertiary care center.

Outcomes:

Primary outcome: To determine whether women who are screened with the PreTRM® test and then managed according to a prespecified algorithm will have a statistically significant reduction in spontaneous PTB < 37 weeks compared to a historical control group.

Secondary outcomes: To determine whether women who are screened with the PreTRM® test and then managed according to a pre-specified treatment algorithm will have a statistically significant reduction in proportion of any type of preterm births (spontaneous and indicated), the total length of hospital stay for spontaneous preterm births, and total length of hospital stay for any preterm birth.

Observations:

  • Neonatal death and stillbirth
  • Birth weight and number of subjects with birth weight <1500g and <2500g
  • Total number of days spent in the NICU and nursery
  • Composite neonatal morbidity score and components
  • Whether or not received surfactant
  • Occurrence of pneumonia
  • Number of days of mechanical ventilation
  • Number of subjects with 5 minute Apgar < 7
  • Occurrence of asphyxia
  • Number of preterm deliveries at <37, <35 and <32 weeks
  • Occurrence of preeclampsia
  • Proportion of primiparous women experiencing preterm birth and spontaneous preterm birth
  • NICU days for spontaneous preterm birth in primiparous women in prospective treatment arm are significantly less than NICU days in primiparous women in the control group of sPTB
  • Correlation of blood levels of 17-OHPC and other progestin levels to outcomes and observations

General Outcomes:

Total cost of hospital care for both the mother and fetus beginning at initiation of care through primary delivery and 28 days of life.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2110 participants
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
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019

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. Spontaneous preterm birth [ Time Frame: Through pregnancy completion, typically 42 weeks ]
    Spontaneous preterm delivery before 37 weeks.


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. Total number of days spent in the NICU and nursery [ Time Frame: Through 60 days post delivery ]
    total nicu days

  5. Composite neonatal morbidity score (appendix 3) and components [ Time Frame: Through 60 days post delivery ]
    Composite neonatal morbidity score composed of Death RDS, IVH, NEC

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

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

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

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

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

  11. 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

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

  13. 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
Criteria

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


Contacts
Contact: Matthew k Hoffman, MD 302 733-3350 Mhoffman@christianacare.org
Contact: Kelly a Ruhthstaller, MD 302733-3350 Kruthstaller@christianacare.org

Locations
United States, Delaware
Christaina Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Matthew K Hoffman, MD    302-733-3350    mhoffman@christianacare.org   
Contact: carrie Kitto, BA    (302) 733-2379    ckitto@christianacare.org   
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Mattehw K Hoffman`, MD ChristianaCare

Publications:

Responsible Party: Matthew Hoffman, Chair Department of OB/GYN, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT03151330     History of Changes
Other Study ID Numbers: ChristianaCHS
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications