About this trial

This is a single center, prospective cohort study of pregnant patients at high risk for spontaneous preterm birth: patient's with history of spontaneous preterm birth, patient's with a short cervix and patient's symptomatic for preterm birth will be included. A control cohort of nulliparous patients without a short cervix will be recruited to provide baseline data. Plan to enroll 240 patients identified through our ultrasound unit with goal of 60 patients in each group.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Maternal age from 18 to 45 years of age.

Singleton gestation.

Disqualifiers

Treatment with vaginal progesterone or intramuscular progestogen within the previous 4 weeks.

History of congestive heart failure, chronic renal failure, or uncontrolled diabetes mellitus, or diabetes mellitus with evidence of end organ dysfunction secondary to vascular disease.

Current pregnancy with a major fetal anomaly or known chromosomal abnormality.

The subject has a marked uterine anatomic malformation that may alter pregnancy duration such as a septated uterus, unicornuate uterus, or uterine didelphys.

Trial population

* Subpopulation 1: Asymptomatic women with or without a history of spontaneous preterm birth who undergo screening for preterm birth with transvaginal sonography between 18-24 weeks of gestation with a cervical length =5mm and up to and including 30mm will be eligible for enrollment. * Subpopulation 2: Asymptomatic with a history of early spontaneous (PTL or PROM as etiology) occurring in a prior pregnancy at 20-34 weeks' gestation. * Subpopulation 3: Patients with symptoms of preterm birth: preterm contractions or preterm premature rupture of membranes at less than 34 weeks. * Control Subpopulation: Nulliparous women with a cervical length of \>30 mm

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants

are grouped into 4 trial groups

Group A: Patients with short cervix

Group B: Patients with a history of spontaneous preterm birth

Group C: Patients with symptoms of preterm birth

Group D: Control/Nulliparous

Trial outcomes

Primary outcomes

1

Inflammatory Cytokine Profile

Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

Time frame

18-24 weeks gestation

2

Inflammatory Cytokine Profile

Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

Time frame

28 weeks gestation

3

Inflammatory Cytokine Profile

Serum and Cervicovaginal cytokine profile (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

Time frame

34 weeks gestation

Secondary outcomes

1

Progesterone Cytokine Response

Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

Time frame

18-24 weeks gestation

2

Progesterone Cytokine Response

Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

Time frame

28 weeks gestation

3

Progesterone Cytokine Response

Serum and cervicovaginal cytokine profiles of those patients receiving progesterone for short cervix before and after exposure. (CRP, ICAM-1, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, MCP-1, PIGF, TNFα, TNFβ)

Time frame

34 weeks gestation

Prospective Evaluation of Pathways for Preterm Birth

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts