Recruiting

Observational Study

Sponsor:

John O'Brien, MD

Code:

NCT05246579

Conditions

Preterm Birth

Cervix; Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Preterm Birth

Cervix; Pregnancy

Study ID

NCT05246579

Start date

Feb 4, 2022

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Maternal age from 18 to 45 years of age.
  • Singleton gestation.

Exclusion Criteria:

  • 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.
  • The subject is considered not capable or unwilling to undergo study procedures and requirements.
  • The subject is symptomatic with vaginal bleeding at enrollment visit.

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with short cervix

Patients with a short cervix identified on transvaginal ultrasound <30 mm

Patients with a history of spontaneous preterm birth

Patients with a history of spontaneous preterm birth (<34 weeks)

Patients with symptoms of preterm birth

Patients with preterm premature rupture of membranes or </=2 cm dilated before 34 weeks gestation.

Control/Nulliparous

Nulliparous patients

Primary outcome measure

  • Inflammatory Cytokine Profile [ Time Frame: 18-24 weeks gestation ]
  • Inflammatory Cytokine Profile [ Time Frame: 28 weeks gestation ]
  • Inflammatory Cytokine Profile [ Time Frame: 34 weeks gestation ]

Central Contacts and Locations

Central contacts

Cynthia Cockerham

859-629-2015cynthia.cockerham@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Cynthia Cockerham

ctcock2@uky.edu

More Information

Sponsor

John O'Brien, MD

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Cervical Length
  • Preterm Birth
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by John O'Brien, MD on 2026-08-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.