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Invasive Prenatal Testing Decisions in Pregnancy After Infertility

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341822
First received: June 19, 2006
Last updated: March 5, 2008
Last verified: December 2007
History of Changes
  Purpose

This study will explore the decision-making experiences of women who are currently pregnant following a period of infertility on whether or not to undergo an invasive prenatal test (IPT) procedure, such as amniocentesis or chorionic villus sampling. Women who become pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. When choosing whether or not to have IPT they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precarious.

Women who are pregnant with their first child after a period of infertility and have made a decision regarding whether or not to undergo IPT may be eligible for this study.

Participants complete an online password-protected questionnaire that measures infertility and decision-making variables and explores women's perceptions of the impact of infertility on their IPT decision-making process. The questionnaire covers the following areas:

  • Subject's demographic information, such as age, marital status, number of children, education, race, ethnicity
  • Subject's infertility history
  • Subject's thoughts and feelings about infertility
  • Subject's thoughts and concerns about other people's (e.g., husband, doctor, other infertile women) opinions about IPT
  • Subject's decision about whether or not to have IPT and her feelings regarding the decision
  • The effect of subject's infertility history on her decision to have or not have IPT

Condition
Pregnancy

Study Type: Observational
Official Title: Prenatal Testing Decisions in Pregnancy After Infertility

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: March 2006
Estimated Study Completion Date: December 2007
Detailed Description:

Women who are pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. When choosing whether or not to have invasive prenatal testing they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precious. The proposed study aims to explore the invasive prenatal testing decision-making experiences of women who are pregnant after infertility. A cross-sectional design will be used to investigate relationships between the infertility experience and decisional conflict associated with deciding whether or not to have invasive prenatal testing. Women who are pregnant after infertility will be recruited from online support groups and websites for pregnancy after infertility. Participants will be asked to complete a questionnaire that measures infertility and decision-making variables and elicits their perceptions of the impact of infertility on their IPT decision-making experience. The main outcome measure is decisional conflict.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Women.

Self-reported history of infertility.

Currently pregnant.

First pregnancy after period of infertility.

Have been offered IPT during current pregnancy for risk of aneuploidy due to maternal age greater than 35 years, abnormal first or second trimester screening or an ultrasound anomaly.

Have made decision about IPT.

Ability to read and write English.

EXCLUSION CRITERIA:

Men, children.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00341822

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00341822     History of Changes
Other Study ID Numbers: 999906132, 06-HG-N132
Study First Received: June 19, 2006
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Amniocentesis
Chorionic Villus Sampling
Fertility
Genetic Counseling
 Decisional Conflict
Prenatal Testing
Questionnaire

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013