CellulaR Injury and Preterm Birth

NCT02441335 | Completed

• 1 other identifier: 821376
• Study Type: observational
• Target: 705
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine how cellular dysfunction can lead to preterm birth. Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture of membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries (greater than 38 weeks) will be enrolled. Medical/obstetric history and pregnancy outcomes will be recorded. Maternal blood, urine and cervical cells (enrollment); cord blood and placental biopsy (delivery) will be collected.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (4)

• Biogenetics

  The role of biogenetics in pregnancy and what are the perturbations in cell metabolism that lead to spontaneous preterm birth.

  5 years

• Microbiome

  The interactions between the microbiome (oral, gut, cervicovaginal, and placental) and host metabolic function in pregnancy.

  5 years

• Cervical remodeling

  How the interactions between cell metabolism and the microbiome influence cervical remodeling and placental function leading to spontaneous preterm delivery.

  5 years

• Genetics and Environmental factors

  How genetic and environmental factors influence the metabolic function of reproductive tissues leading to spontaneous preterm delivery.

  5 years

Study Arms (3)

Group 1 (Preterm labor, PPROM, cervical insufficiency)

Singleton pregnancy between 20 0/7 36 6/7 weeks gestational age who is admitted with PTL or cervical insufficiency (Equal or greater than 2 cm dilated) or PPROM

Group 2 (Term labor)

Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes

Group 3 (PTB-medically indicated)

Singleton pregnancy between 20 0/7 34 5/6 weeks gestational age who is admitted with a medically indicated preterm birth (IOL for abruption, non reassuring fetal heart tones, intrauterine growth restriction, preeclampsia, trauma, etc.)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

At HUP, there are approximately 4,200 deliveries a year, of which approximately 10 percent (420) deliver preterm. Among these preterm births, two-thirds (280) are spontaneous, which is the focus of our research. Many women who ultimately have a preterm birth, first present with preterm labor. Women who have advanced dilatation, preterm rupture of membranes, etc are at high risk for having a preterm birth. The investigators anticipate, based on the number of spontaneous preterm births at HUP per year, enrolling about 40-50% of those eligible and understanding that about 40% of those enrolled will have a preterm birth, we should be able to enroll about 112 women per year over 5 years. The coordinators will enroll cases who are admitted to the hospital with PTL, PPROM, or cervical insufficiency at 20-0/7 to 36-6/7 weeks.

You may qualify if:

• years of age
• Singleton pregnancy between 20 0/7 and 36 6/7 weeks gestational age who is admitted with preterm labor or cervical insufficiency (greater than 2 cm dilation) or Preterm Premature Rupture of Membranes

You may not qualify if:

• Multiple gestation
• Fetal chromosomal abnormality
• Major fetal anomaly
• Intra-uterine fetal demise
• Gestational hypertension/preeclampsia
• Controls:
• years of age
• Singleton pregnancy that delivers at term (38 to 41 weeks gestational age)
• Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes
• Multiple gestation
• Fetal chromosomal abnormality
• Major fetal anomaly
• Intra-uterine fetal demise
• Intra-uterine growth restriction
• Gestational hypertension/preeclampsia

Sponsors & Collaborators

• University of Pennsylvania: lead
• March of Dimes: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1\. Collect blood, urine and cervicovaginal cells from women with preterm labor and term labor in order to investigate: 1. What is the role of bioenergetics in pregnancy and what are the pertubations in cell metabolism that lead to spontaneous preterm birth 2. What are the interactions between the microbiome (oral, gut, cervicovaginal, and placental) and host metabolic function in pregnancy 3. How do interactions between cell metabolism and the microbiome influence cervical remodeling and placental function leading to spontaneous preterm delivery 4. What genetic and environmental factors influence the metabolic function of reproductive tissues leading to spontaneous preterm delivery

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michal Elovitz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

US (1)