Miscarriage Clinical Trial
Official title:
The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage
Verified date | January 2015 |
Source | Medstar Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Women presenting to Washington Hospital Center with fetal loss would be offered
participation in the study. The objective is to determine if ccffDNA obtained from maternal
blood is present in the setting of missed abortion or fetal demise.
The investigators primary hypothesis is that cell free fetal DNA will be present in maternal
blood in the presence of a failed pregnancy.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women diagnosed with Intrauterine fetal demised or missed abortion Exclusion Criteria: - Patients diagnosed with threatened abortion with cardiac activity present - Patients with IUFD who have delivered the fetus (the induction process may already be in process, however, the fetus and placenta must be in situ at the time of blood sampling) - Patients with known genetic abnormalities or mental retardation as a result of chromosomal abnormalities 13, 18, 21, or sex chromosomes. - Children under the age of 18 - Patients not fluent in or unable to consent to the study in English |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Medstar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Medstar Research Institute | Sequenom Laboratories |
United States,
American Congress of Obstetricians and Gynecologists, Management of Stillbirth. ACOG Practice Bulletin, 2009. 102
Baena N, Guitart M, Ferreres JC, Gabau E, Corona M, Mellado F, Egozcue J, Caballín MR. Fetal and placenta chromosome constitution in 237 pregnancy losses. Ann Genet. 2001 Apr-Jun;44(2):83-8. — View Citation
Kyle PM, Sepulveda W, Blunt S, Davies G, Cox PM, Fisk NM. High failure rate of postmortem karyotyping after termination for fetal abnormality. Obstet Gynecol. 1996 Nov;88(5):859-62. — View Citation
MacDorman MF, Kirmeyer S. Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19. — View Citation
Nagaishi M, Yamamoto T, Iinuma K, Shimomura K, Berend SA, Knops J. Chromosome abnormalities identified in 347 spontaneous abortions collected in Japan. J Obstet Gynaecol Res. 2004 Jun;30(3):237-41. — View Citation
Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Deciu C, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011 Nov;13(11):913-20. doi: 10.1097/GIM.0b013e3182368a0e. — View Citation
Reddy UM, Page GP, Saade GR. The role of DNA microarrays in the evaluation of fetal death. Prenat Diagn. 2012 Apr;32(4):371-5. doi: 10.1002/pd.3825. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy. | Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise | During initial presentation for treatment | No |
Secondary | The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue. | 3-4 weeks after specimen processing | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05969574 -
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
|
||
Enrolling by invitation |
NCT01689428 -
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
|
Phase 3 | |
Completed |
NCT00194844 -
Couples Miscarriage Healing Project:Randomized Trial
|
Phase 1/Phase 2 | |
Recruiting |
NCT05789940 -
Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention
|
N/A | |
Recruiting |
NCT03628625 -
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
|
Phase 2 | |
Not yet recruiting |
NCT05557201 -
Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
|
||
Not yet recruiting |
NCT05579756 -
Psychatric Impact of Miscarriage in Assiut University Hospital
|
||
Not yet recruiting |
NCT05039853 -
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
|
N/A | |
Recruiting |
NCT01223482 -
A Study Looking at Women's Experiences After a Miscarriage
|
N/A | |
Completed |
NCT04604366 -
Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage
|
Phase 2 | |
Not yet recruiting |
NCT05088720 -
Misoprostol for Management of Women With an Incomplete Miscarriage
|
N/A | |
Not yet recruiting |
NCT05103098 -
Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
|
N/A | |
Not yet recruiting |
NCT05094375 -
Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
|
N/A | |
Not yet recruiting |
NCT05088707 -
Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
|
N/A | |
Recruiting |
NCT05304273 -
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
|
Phase 3 | |
Not yet recruiting |
NCT05653414 -
Interest of a Short Early Psychological Care in Women With Miscarriage
|
N/A | |
Recruiting |
NCT03976544 -
Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients
|
Phase 4 | |
Completed |
NCT03940495 -
Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
|
||
Completed |
NCT04512820 -
Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study
|
N/A | |
Recruiting |
NCT05762770 -
A Trial of Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception
|
N/A |