Invasive Prenatal Testing Decisions in Pregnancy After Infertility

Pregnancy Clinical Trial

Official title:

Prenatal Testing Decisions in Pregnancy After Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00341822
• Other study ID #: 999906132
• Secondary ID: 06-HG-N132
• Status: Completed
• Phase: N/A
• First received: June 19, 2006
• Last updated: June 30, 2017
• Start date: March 29, 2006
• Est. completion date: December 28, 2007

Study information

• Verified date: December 28, 2007
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 28, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Infertility
• Pregnancy

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation