Prospective Evaluation of Pathways for Preterm Birth

Launched by JOHN O'BRIEN, MD · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying ways to better understand and manage the risk of preterm birth, which is when a baby is born before 37 weeks of pregnancy. The research will involve pregnant women who are at high risk for spontaneous preterm birth, such as those with a history of preterm birth, a short cervix, or symptoms indicating they might give birth early. The study will also include a comparison group of first-time expectant mothers who do not have a short cervix. The goal is to enroll 240 women, with around 60 in each group.

To participate, women must be between 18 and 45 years old and pregnant with one baby. However, some women may not be eligible if they have certain health conditions, are currently receiving specific hormone treatments, or have complications like heavy bleeding. Participants can expect to contribute to important research that could help improve care for future pregnancies at risk for preterm birth, and they will be closely monitored throughout the study.

Gender

FEMALE

Eligibility criteria

• 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.