Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)

Preterm Birth Clinical Trial

Official title:

Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03530332
• Other study ID #: PREVENT-PTB Protocol 1.02
• Status: Terminated
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2020
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is being done to find out whether a screening blood test can help identify women with an increased risk of preterm birth.

Description:

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 methods.

Women who are 18 years or older, with a singleton pregnancy between 19 5/7 weeks and 20 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment and no history of prior preterm birth (delivery between 16 0/7 weeks and 37 6/7 weeks) will be invited to participate. Women who enroll will be randomized to screening and intervention for those at high risk of PTB or no screening and standard care. All participants will undergo sample collection, but the samples from the group randomized to "no screening' will not be analyzed until the end of the study (post-delivery of all neonates).

Women randomized to the intervention group 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 pre-specified algorithm. The outcomes of these women will be compared to a control group of women who do not receive screening at the same tertiary care center.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1208
• Est. completion date: August 30, 2019
• Est. primary completion date: February 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Subject is greater than or equal to 18 years of age AND

2. Uncomplicated singleton intrauterine pregnancy less than 21 weeks estimated gestation AND

3. No medical contraindications to continuing pregnancy AND

4. No previous classical cesarean section AND

5. No known uterine anomaly AND

6. No history of cervical conization AND

7. No plan for cesarean section prior to 37 0/7 weeks gestation AND

8. No plan for induction of labor prior to 37 0/7 weeks gestation AND

9. Subject has no history of spontaneous preterm delivery AND

10. No prior PPROM less than 34 weeks AND

11. Subject has no signs and/or symptoms of preterm labor AND

12. Subject has intact membranes AND

13. Subject has not received a blood transfusion during the current pregnancy.

Exclusion Criteria

1. Subjects who have taken or plan to take progesterone beyond 13 6/7 weeks gestation prior to study enrollment OR

2. Any other medical conditions that put subject at increased risk of preterm birth in the judgment of the site investigator OR

3. The subject has a planned cerclage placement for the current pregnancy OR

4. Previously identified short cervix (less than 2.5 cm by transvaginal ultrasound) prior to enrollment OR

5. Known major structural fetal anomalies that may shorten pregnancy (e.g., anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia) OR

6. Known fetal genetic anomalies that are incompatible with life (e.g., trisomy 13 or trisomy 18) OR

7. The subject has known elevated bilirubin levels (hyperbilirubinemia) OR

8. 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, low dose aspirin OR

9. A history of allergic reaction to aspirin or 17-OHPC injections OR

10. Subject does not plan to deliver at an Intermountain Healthcare hospital.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Diagnostic Test:
• PreTRM test
Blood test to determine risk of preterm birth

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	McKay-Dee Hospital	Ogden	Utah
United States	Utah Valley Hospital	Provo	Utah
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Ware Branch	Sera Prognostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of spontaneous preterm birth		Before 37 weeks of pregnancy
Secondary	Gestational age at delivery		At delivery
Secondary	Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU		Up to 1 year post delivery
Secondary	Length of stay among all neonates (including NICU and nursery)		Up to 1 year post delivery
Secondary	Neonatal costs		Up to 1 year post delivery