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

NCT03151330 | Completed DMC

• 1 other identifier: DDD603819
• Study Type: interventional
• Target: 1,873
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

• Neonatal Mortality Index

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

  Birth through 6 months

• Neonatal NICU length of stay

  Duration of hospitalization in the NICU

  Birth to 6 months

Secondary Outcomes (2)

• Preterm birth

  Through pregnancy completion, typically 42 weeks

• Total length of hospital stay for any preterm birth

  From birth to 60 days post delivery

Other Outcomes (11)

• Neonatal death and stillbirth

  Through 42 days post delivery

• Birthweight and if birthweight was <1500g

  At time of delivery

• Birthweight and if birthweight was <2500gm

  At time of delivery

Study Arms (1)

Screened arm

OTHER

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

Interventions

Screened Arm OTHER

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.

Screened arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: requires pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Related Publications (7)

• Anderson RN, Smith BL. Deaths: leading causes for 2001. Natl Vital Stat Rep. 2003 Nov 7;52(9):1-85.

  PMID: 14626726 BACKGROUND

• Berghella V, Rafael TJ, Szychowski JM, Rust OA, Owen J. Cerclage for short cervix on ultrasonography in women with singleton gestations and previous preterm birth: a meta-analysis. Obstet Gynecol. 2011 Mar;117(3):663-671. doi: 10.1097/AOG.0b013e31820ca847.

  PMID: 21446209 BACKGROUND

• CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994 Mar 12;343(8898):619-29.

  PMID: 7906809 BACKGROUND

• Esplin MS, Elovitz MA, Iams JD, Parker CB, Wapner RJ, Grobman WA, Simhan HN, Wing DA, Haas DM, Silver RM, Hoffman MK, Peaceman AM, Caritis SN, Parry S, Wadhwa P, Foroud T, Mercer BM, Hunter SM, Saade GR, Reddy UM; nuMoM2b Network. Predictive Accuracy of Serial Transvaginal Cervical Lengths and Quantitative Vaginal Fetal Fibronectin Levels for Spontaneous Preterm Birth Among Nulliparous Women. JAMA. 2017 Mar 14;317(10):1047-1056. doi: 10.1001/jama.2017.1373.

  PMID: 28291893 BACKGROUND

• Rittenberg C, Newman RB, Istwan NB, Rhea DJ, Stanziano GJ. Preterm birth prevention by 17 alpha-hydroxyprogesterone caproate vs. daily nursing surveillance. J Reprod Med. 2009 Feb;54(2):47-52.

  PMID: 19301566 BACKGROUND

• Saade GR, Boggess KA, Sullivan SA, Markenson GR, Iams JD, Coonrod DV, Pereira LM, Esplin MS, Cousins LM, Lam GK, Hoffman MK, Severinsen RD, Pugmire T, Flick JS, Fox AC, Lueth AJ, Rust SR, Mazzola E, Hsu C, Dufford MT, Bradford CL, Ichetovkin IE, Fleischer TC, Polpitiya AD, Critchfield GC, Kearney PE, Boniface JJ, Hickok DE. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016 May;214(5):633.e1-633.e24. doi: 10.1016/j.ajog.2016.02.001. Epub 2016 Feb 11.

  PMID: 26874297 BACKGROUND

• Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. doi: 10.1002/uog.17397.

  PMID: 28067007 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew K Hoffman, MD

  ChristianaCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Department of OB/GYN

Model Details: Women who are found to have an elevated risk of preterm birth will receive counseling regarding potential interventions and compared to historical controls

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: May 12, 2017
• Study Start: June 15, 2018
• Primary Completion: March 16, 2020
• Study Completion: June 1, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)