- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00341263
Maternal and Umbilical Cord Hormone Concentrations in Twin and Singleton Pregnancies
Study of Maternal and Umbilical Cord Hormone Concentrations in Monochorionic and Dichorionic Pregnancies
This study will examine levels of hormones, such as estrogen and testosterone, in maternal and umbilical cord blood to compare hormones between mothers who are having twins and mothers who are having one baby. It will investigate whether hormone levels in twin versus singleton pregnancies influence the babies' risk of developing breast, prostate, and testicular cancers later in life.
Pregnant women 18 years of age and older who do not have preeclampsia, chronic hypertension, pre-pregnancy or gestational diabetes, thyroid disease, or other major pregnancy complications are eligible for this study. Participants will be recruited from the obstetrics and gynecology practice at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.
Participants will have a blood sample drawn from their arm during their third trimester prenatal visit and again when they are admitted to the hospital for delivery. After the baby is born, a blood sample will be collected from the cut umbilical cord. Information about the pregnancy and delivery will be collected from the mother's medical chart, and information about the baby's size will be obtained from the baby's medical chart.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Hampshire
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Hanover, New Hampshire, United States, 03756
- Darmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA/EXCLUSION CRITERIA:
Eligible for study are pregnant women 18 years of age and older.
We will try to recruit women who do not have preeclampsia, chronic hypertension, pre-pregnancy or gestational diabetes, thyroid disease or other major pregnancy complications.
CASES:
Eligible women who are pregnant with twins.
CONTROLS (Singletons):
Three control groups will be recruited: two for the mother of twins (one at the third trimester, one at delivery), and one for the twins themselves at delivery.
A singleton pregnancy that meets the eligibility criteria and can be matched to the case pregnancy on gestational age (within 1 week), parity (nulliparous vs. parous) and maternal age (+/- 5 years) will be recruited for study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cases - twin pregnancies
Maternal and cord hormones in twins
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Controls - singleton pregnancies
Maternal and cord hormones in singletons
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hormone concentrations
Time Frame: Pregnancy
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Analysis of maternal and cord blood hormone concentrations inmonochorionic twin, dichorionic twin and singleton pregnancies of similar gestational age--especially with respect to cancer risk.
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Pregnancy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Troisi, D.Sc., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Andersson SW, Bengtsson C, Hallberg L, Lapidus L, Niklasson A, Wallgren A, Hulthen L. Cancer risk in Swedish women: the relation to size at birth. Br J Cancer. 2001 May 4;84(9):1193-8. doi: 10.1054/bjoc.2000.1738.
- Braun MM, Ahlbom A, Floderus B, Brinton LA, Hoover RN. Effect of twinship on incidence of cancer of the testis, breast, and other sites (Sweden). Cancer Causes Control. 1995 Nov;6(6):519-24. doi: 10.1007/BF00054160.
- Buell P. Changing incidence of breast cancer in Japanese-American women. J Natl Cancer Inst. 1973 Nov;51(5):1479-83. doi: 10.1093/jnci/51.5.1479. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 999904052
- 04-C-N052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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