Pregnancy Complications Clinical Trial
— DAASOfficial title:
Use of a Novel Decision Aid for Prenatal Aneuploidy Screening
Verified date | January 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.
Status | Completed |
Enrollment | 197 |
Est. completion date | January 12, 2018 |
Est. primary completion date | January 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Pregnancy at less than 22 weeks gestation - English or Spanish speaking - Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy screening Exclusion Criteria: - Known fetal anomalies - Known multiple gestations - Prior genetic counseling or aneuploidy screening in current pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | North Carolina Translational and Clinical Sciences Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knowledge Score | All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge. | At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes | |
Secondary | Decisional Conflict Score | A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict. | At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes | |
Secondary | Test Chosen | For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling. | At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes | |
Secondary | Supplementary Tests Performed | Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation. | 22 weeks gestation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Completed |
NCT06338254 -
Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women
|
N/A | |
Recruiting |
NCT04825093 -
Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19
|
N/A | |
Completed |
NCT04739462 -
SMS Maama Project COVID-19
|
N/A | |
Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
Recruiting |
NCT03313024 -
Berlin-Brandenburg Pregnancy Cohort
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06357962 -
Semi-permanent Acupuncture Effect on Cervical Ripening
|
N/A | |
Not yet recruiting |
NCT06430853 -
Psychobiological Interventions in Pregnancy
|
N/A | |
Not yet recruiting |
NCT03661749 -
Urinary Protein to Creatinine Ratio in Term Pregnant Women
|
N/A | |
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Completed |
NCT02191774 -
Medical Abortion up to 10 Weeks Gestation at Home
|
||
Completed |
NCT01322529 -
Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be
|
N/A | |
Completed |
NCT00746551 -
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
|
Phase 4 | |
Completed |
NCT00678080 -
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
|
N/A | |
Completed |
NCT00634530 -
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
|
N/A | |
Completed |
NCT00197561 -
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
|
Phase 3 | |
Completed |
NCT05527327 -
Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study
|
N/A | |
Recruiting |
NCT05551078 -
Thrombophilia Screening After Severe IUGR
|
||
Recruiting |
NCT03100084 -
PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome
|