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Screened arm for Premature Birth
N/A
Waitlist Available
Led By Matthew K Hoffman, MD
Research Sponsored by Christiana Care Health Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to 6 months
Awards & highlights
Study Summary
This trial is testing whether a screening test called PreTRM can help doctors identify which pregnant women are at risk for preterm birth. They hope that by providing interventions to these women, they will see a decrease in neonatal morbidity/mortality, length of stay in the hospital, and length of stay in the NICU.
Eligible Conditions
- Premature Birth
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ birth to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neonatal Mortality Index
Neonatal NICU length of stay
Secondary outcome measures
Preterm birth
Total length of hospital stay for any preterm birth
Other outcome measures
Birthweight and if birthweight was <1500g
Birthweight and if birthweight was <2500gm
Neonatal death and stillbirth
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Screened armExperimental Treatment1 Intervention
This will be an arm of women who are prospectively screened and receive a risk score for preterm birth. They will be recommended treatment strategies and their outcomes compared to an historical control.
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Who is running the clinical trial?
Christiana Care Health ServicesLead Sponsor
116 Previous Clinical Trials
105,541 Total Patients Enrolled
18 Trials studying Premature Birth
10,083 Patients Enrolled for Premature Birth
Matthew K Hoffman, MDPrincipal InvestigatorChristianaCare
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with more than one baby, but one of the babies has been lost due to a reduction procedure or other reasons.You have previously had a procedure called cervical conization.The baby in the womb has genetic abnormalities that are not compatible with a healthy life. Some examples are trisomy 13 and trisomy 18. The decision about other genetic abnormalities will be made by the doctors at the research site.If you have certain serious birth defects that could affect the length of your pregnancy, you may not be able to participate. Examples of these birth defects include anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia, and pyloric stenosis. However, minor birth defects like extra fingers or one kidney with swelling will not prevent you from participating. Other birth defects will be decided by the doctors at the research site.You have had a premature birth before 37 weeks of pregnancy or your water broke before 34 weeks of pregnancy.You have a problem with your uterus or have had a certain type of C-section in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Screened arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining slots available for participants in this research project?
"This study, which was initially posted on June 15th 2018 and last updated July 11th 2022, is no longer recruiting participants. Nonetheless, 261 different medical trials are currently seeking enrolment across the globe."
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