Premature Birth Clinical Trial
Official title:
Precision Medicine In Segregating Endotypes in Preterm Birth
This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation. However, it is not well known why it works for some women but not for others. There are limited available interventions for the prevention of recurrent PTB. This study will enroll 150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC and 20% will decline use. We will obtain blood samples and samples of cervical cells and cervical vaginal fluid. The objective of the study is to identify genetic, microbial and molecular markers that help to identify which women at risk for recurrent preterm birth will respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized screening test based on these markers.
Women with a prior preterm birth will be recruited between 16 and 22 weeks gestation. At this initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be collected. Approximately 8 weeks later, those samples will be collected a second time, along with a blood sample. Outcome data will be collected after delivery. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05048550 -
Babies in Glasses; a Feasibility Study.
|
N/A | |
| Active, not recruiting |
NCT03655639 -
Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
|
||
| Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
| Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
| Completed |
NCT03337659 -
A Cluster Randomized Controlled Trial of FICare at 18 Months
|
N/A | |
| Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
| Completed |
NCT03251729 -
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
|
Phase 4 | |
| Not yet recruiting |
NCT05039918 -
Neonatal Experience of Social Touch
|
N/A | |
| Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
| Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
| Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
| Not yet recruiting |
NCT02880696 -
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
|
N/A | |
| Completed |
NCT02913495 -
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
|
Phase 4 | |
| Completed |
NCT02661360 -
Effects of Swaddling on Infants During Feeding
|
N/A | |
| Completed |
NCT02743572 -
Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
|
N/A | |
| Completed |
NCT02879799 -
Family Integrated Care (FICare) in Level II NICUs
|
N/A | |
| Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
| Completed |
NCT01163188 -
Social Adjustment and Quality of Life After Very Preterm Birth
|
N/A | |
| Terminated |
NCT00675753 -
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
|
N/A | |
| Terminated |
NCT00179972 -
Evaluation of Pulse Oximetry Sensors in Neonates
|
N/A |