Trial Outcomes & Findings for National Prevalence and Impact of Noninvasive Prenatal Testing (NCT NCT02284399)

Last Updated: 2019-06-19

Results Overview

Total Number of patient undergoing invasive diagnostic testing for fetal karyotype (IDTFK) before (control group = Jan - July 2010) and after (test group=Jan 2012-June 2014) NIPT testing came to market

Recruitment status

COMPLETED

Target enrollment

4488 participants

Primary outcome timeframe

4 years

Results posted on

2019-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	IDTFK Group Pre-NIPT (January 2010-July 2010) A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). * non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation. * Invasive Diagnostic testing for Fetal Karyotype (IDTFK) = Amniocentesis or chorionic villus sampling (CVS)	IDTFK Group Post NIPT - (January 2012-June 2014) Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). * non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation. * Invasive Diagnostic testing for Fetal Karyotype (IDTFK) = Amniocentesis or CVS
Overall Study STARTED	1414	3074
Overall Study COMPLETED	1414	3074
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Note: percentages sum to more than 100% because some patient had more than one indication.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 4 years

Population: This was an observational study that looked to compare the number of patient who underwent IDTFK during Jan 2010-July 2010 (prior to the adoption of NIPT) with the number of patients who underwent IDTFK during Jan 2012-June 2014 (after the adoption of NIPT).

Outcome measures

Outcome measures
Measure	IDTFK Group Pre-NIPT (January 2010-July 2010) n=1414 Participants A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).	IDTFK Group Post NIPT - (January 2012-June 2014) n=3074 Participants Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation
Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market	1414 Participants	3074 Participants

SECONDARY outcome

Timeframe: 4 years

Population: The number of positive tests identified between the control and the test periods.

Will determine if frequency of positive tests for abnormal karyotypes between the control period and the study period where different.

Outcome measures

Outcome measures
Measure	IDTFK Group Pre-NIPT (January 2010-July 2010) n=3074 Participants A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).	IDTFK Group Post NIPT - (January 2012-June 2014) n=1414 Participants Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation
Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.	454 Participants	104 Participants

Adverse Events

IDTFK Group Pre-NIPT (January 2010-July 2010)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IDTFK Group Post NIPT - (January 2012-June 2014)

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

Kimberly Maurel

Mednax. Inc

Phone: 714-593-9171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IDTFK Group Post NIPT - (January 2012-June 2014) n=3074 Participants Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).	IDTFK Group Pre-NIPT (January 2010-July 2010) n=1414 Participants A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).	Total n=4488 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3074 Participants n=5 Participants	1414 Participants n=7 Participants	4488 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3074 Participants n=5 Participants	1414 Participants n=7 Participants	4488 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Indication for invasive test was Advance Maternal Age (AMA)	2071 Participants n=5 Participants	996 Participants n=7 Participants	3067 Participants n=5 Participants
Indication for invasive test was Family History of Aneuploidy	304 Participants n=5 Participants	127 Participants n=7 Participants	431 Participants n=5 Participants
Indication for invasive test was a Positive Serum Screening Test	995 Participants n=5 Participants	499 Participants n=7 Participants	1494 Participants n=5 Participants
Indication for invasive test was Ultrasound Abnormality noted	961 Participants n=5 Participants	292 Participants n=7 Participants	1253 Participants n=5 Participants
Indication for and invasive test was a Positive cell free DNA (cfDNA)	133 Participants n=5 Participants	0 Participants n=7 Participants	133 Participants n=5 Participants
Karyotype Results of Amniocentesis and CVS - Normal Result Normal karyotype	2687 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	1310 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	3997 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Karyotype Results of Amniocentesis and CVS - Normal Result T21	205 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	60 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	265 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Karyotype Results of Amniocentesis and CVS - Normal Result T18	72 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	19 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	91 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Karyotype Results of Amniocentesis and CVS - Normal Result T13	24 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	5 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	29 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Karyotype Results of Amniocentesis and CVS - Normal Result 45X	34 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	6 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	40 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Karyotype Results of Amniocentesis and CVS - Normal Result 47XXY	6 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	4 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	10 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Karyotype Results of Amniocentesis and CVS - Normal Result OTHER	40 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	10 indications n=7 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.	50 indications n=5 Participants • Note: percentages sum to more than 100% because some patient had more than one indication.
Indication for an invasive test was multifetal gestation	76 Participants n=5 Participants	29 Participants n=7 Participants	105 Participants n=5 Participants