Maternal Gut Microbiome (MGM) Study of Diet, the Gut Microbiome and Preterm Birth
MGM
1 other identifier
observational
400
1 country
1
Brief Summary
The purpose of this study is to determine whether diet and the gut microbiome play a role in spontaneous preterm birth (SPTB), namely delivery of the fetus prior to 37 weeks gestation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2015
CompletedFirst Submitted
Initial submission to the registry
September 23, 2015
CompletedFirst Posted
Study publicly available on registry
September 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2017
CompletedMay 2, 2018
May 1, 2018
2.3 years
September 23, 2015
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preterm Birth
At time of delivery
Study Arms (2)
Preterm Labor
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
Term Labor
Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes
Eligibility Criteria
Pregnant women will be recruited from three locations: Penn ObGyn Associates, Helen O. Dickens Clinic, and Maternal Fetal Medicine at 2000 Courtyard. Potential subjects will be identified from clinical schedules and will be pre-screened in EPIC for eligibility. They may be approached during a clinical visit, or the research team may call them prior to or after a scheduled visit to introduce the study. Women can be enrolled anytime between the confirmation of pregnancy and 24 weeks/0 days gestation. For convenience, research visits can be conducted at the time of a scheduled clinical visit, or at a separate time.
You may qualify if:
- Pregnant women receiving care in University of Pennsylvania Health System
- Between 16-24 weeks gestation
You may not qualify if:
- Multiple gestation
- Fetal chromosomal abnormality or major fetal anomaly
- Intrauterine fetal demise
- Maternal HIV
- Chronic kidney disease
- Transplant
- Prior weight loss surgery
- Vegan diet
- Chronic use of immunosuppresive medications or steriods
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- March of Dimescollaborator
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Biospecimen
1\. Collect stool, maternal blood, cord blood, and placenta from women with preterm and term labor in order to investigate whether diet and gut microbiome play a role in preterm birth.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2015
First Posted
September 25, 2015
Study Start
May 4, 2015
Primary Completion
August 29, 2017
Study Completion
August 29, 2017
Last Updated
May 2, 2018
Record last verified: 2018-05