Motherhood and Microbiome (M&M)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02030106|
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : September 12, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||2000 participants|
|Official Title:||Revealing the Role of the Cervico-vaginal Microbiome in Spontaneous Preterm Birth|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 3, 2017|
|Actual Study Completion Date :||June 1, 2017|
Prior Preterm Birth Patients
All obstetrical patients eligible for the study that have had a prior preterm birth.
Term Birth Patients
All obstetrical patients eligible for the study that have not had a prior preterm birth.
- Cervicovaginal Microbiota in Women With and Without Preterm Birth [ Time Frame: Enrollment through delivery ]Cervicovaginal Microbiota in Women With and Without Preterm Birth
- Potential Modifiers of the Cervicovaginal Microbiome [ Time Frame: Enrollment through delivery ]Potential modifiers of the cervicovaginal microbiome: behavioral factors, stress, nutrition/obesity, vaginal infections, genetic or host immune differences, race and ethnicity, social behaviors, environmental influences
Biospecimen Retention: Samples With DNA
Women will self-collect samples of their cervicovaginal fluid using large cotton swabs.
Subjects who have had a previous preterm birth will also have cervical cells collected in the same manner that cells are collected for a routine pap smear.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030106
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Michal A Elovitz, MD||University of Pennsylvania|