Trial Outcomes & Findings for The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage (NCT NCT01916928)
NCT ID: NCT01916928
Last Updated: 2017-03-13
Results Overview
Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
During initial presentation for treatment
Results posted on
2017-03-13
Participant Flow
Participant milestones
| Measure |
Non-viable Pregnancy
Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage
Baseline characteristics by cohort
| Measure |
Non-viable Pregnancy
n=50 Participants
Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
|
|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 6.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: During initial presentation for treatmentPercentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise
Outcome measures
| Measure |
Non-viable Pregnancy
n=50 Participants
Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
|
|---|---|
|
The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 3-4 weeks after specimen processingOutcome measures
Outcome data not reported
Adverse Events
Non-viable Pregnancy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cecily A. Clark-Ganheart
Medstar Washington Hospital Center
Phone: 202-877-3067
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place