Maternal and Umbilical Cord Hormone Concentrations in Twin and Singleton Pregnancies

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341263
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
Cancer

Study Type: Observational
Official Title: Study of Maternal and Umbilical Cord Hormone Concentrations in Monochorionic and Dichorionic Pregnancies

Resource links provided by NLM:


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

Estimated Enrollment: 120
Study Start Date: November 2003
Detailed Description:

Epidemiologic data are few but suggest that effects during the prenatal and early life periods may be important in influencing risk of breast, prostate and testicular cancers later in life. In particular, evidence is accumulating for associations with several maternal, perinatal and pregnancy characteristics, including twining. The effect of these factors may be mediated through alterations in hormone levels such as the estrogens and other steroid hormones, to which the embryo and fetus are exposed during pregnancy. Differences in maternal hormone concentrations by maternal and perinatal factors have been noted, though data for most factors are sparse. Furthermore, less is known about the relationships of pregnancy factors to hormones in cord blood, the proximal exposure to the fetus, since most work thus far has been based on hormones in the maternal circulation. In collaboration with investigators at Dartmouth Hitchcock Medical Center, we are collecting maternal and cord blood samples from monochorionic twin, dichorionic twin and singleton pregnancies of similar gestational age to quantify differences in concentrations of several hormones and other pregnancy products. The purpose of the study is to assess the consistency of these data with hypotheses regarding the altered cancer risk daughters of twin pregnancies experience. All data collection is completed. We are currently analyzing the data for development of manuscripts to be submitted for publication.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341263

Locations
United States, New Hampshire
Darmouth-Hitchcock Medical Center
Hanover, New Hampshire, United States, 03756
Sponsors and Collaborators
Investigators
Principal Investigator: Rebecca Troisi, D.Sc. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00341263     History of Changes
Other Study ID Numbers: 999904052, 04-C-N052
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Twins
Estrogens
Androgens
Breast Cancer
In-Utero
Singletons
Angiogenic Factors
Umbilical Cord

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014