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Invasive Prenatal Testing Decisions in Pregnancy After Infertility

Primary Purpose

Pregnancy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Human Genome Research Institute (NHGRI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Pregnancy focused on measuring Amniocentesis, Chorionic Villus Sampling, Fertility, Genetic Counseling, Decisional Conflict, Prenatal Testing, Questionnaire

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2006
Last Updated
June 30, 2017
Sponsor
National Human Genome Research Institute (NHGRI)
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1. Study Identification

Unique Protocol Identification Number
NCT00341822
Brief Title
Invasive Prenatal Testing Decisions in Pregnancy After Infertility
Official Title
Prenatal Testing Decisions in Pregnancy After Infertility
Study Type
Observational

2. Study Status

Record Verification Date
December 28, 2007
Overall Recruitment Status
Completed
Study Start Date
March 29, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 28, 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Human Genome Research Institute (NHGRI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Amniocentesis, Chorionic Villus Sampling, Fertility, Genetic Counseling, Decisional Conflict, Prenatal Testing, Questionnaire

7. Study Design

Enrollment
200 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2663553
Citation
Reading AE, Chang LC, Kerin JF. Attitudes and anxiety levels in women conceiving through in vitro fertilization and gamete intrafallopian transfer. Fertil Steril. 1989 Jul;52(1):95-9. doi: 10.1016/s0015-0282(16)60796-3.
Results Reference
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Invasive Prenatal Testing Decisions in Pregnancy After Infertility

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