Protein and Ultrasound Indicators of Preterm Birth

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Preterm Birth

Study type: Observational

Funder types: Other

Identifiers

NCT01412931

11-0570

Details and patient eligibility

About

Women are being asked to participate in a research study that is looking for new methods to understand and predict premature birth (birth before 37 weeks of pregnancy-full term pregnancy is 40 weeks). In this study the investigators will be looking at proteins in vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and stiffness, in order to try to know who will have a preterm birth and who will reach full term. The investigators will collect the vaginal fluid samples and perform ultrasounds both in the clinic throughout pregnancy in normal women, and from women admitted to the hospital because they are in early labor. The investigators will collect the placental tissue after the baby is born (this is normally discarded). This study will help us to understand the process of preterm birth and the investigators hope that this will eventually allow us to develop better methods to treat preterm labor and prevent the birth of premature babies.

Enrollment: 3 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Single live intrauterine pregnancy
• Good gestational age dating

Exclusion criteria

• History of prior cervical procedure such as LEEP, CKC, or cryotherapy
• Maternal or fetal indication for preterm delivery
• Cerclage in place

Trial design

3 participants in 3 patient groups

1) Pregnant women with a single intrauterine pregnancy

Description:

50 women with uncomplicated pregnancies and no history of preterm birth.

2) Pregnant women with a single intrauterine pregnancy

Description:

50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).

3) Pregnant women with a single intrauterine pregnancy

Description:

20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.