General Information

Age Group

Adults

Status

Active

Protocol Number

NCT05515744

Background Information

Neonatal health has life-long implications with regards to childhood growth and development, and adult cardiometabolic and mental health outcomes. There is a critical data gap with regards to determinants of fetal growth and neonatal outcomes, particularly paternal health factors, fetal genetic factors, and timing of delivery.

The goal of this study is to investigate these three aims:

  • To determine whether paternal cardiovascular risk factors are associated with fetal growth, and placental function and whether semen epigenetic differences explain associations
  • fetal genetic and placental epigenetic markers influencing fetal growth and neonatal outcomes
  • determining the optimal timing of delivery for women with gestational diabetes (GDM) with lowest risk to neonatal morbidity and perinatal mortality

Offered At

3300 Gallows Rd.
Falls Church, VA 22042

Principal Investigator

G. Larry Maxwell, MD

Eligibility Information

Aim 1 (paternal factors)

Women inclusion criteria:

  • 18 years or older
  • Your gestational age is less than 20 weeks and 0 days (soon to be 24 weeks and 0 days)
  • You are English or Spanish speaker
  • You are having a single intrauterine pregnancy
  • You plan to deliver at the study site hospital
  • The father of the baby is willing to participate as well

Male partners inclusion criteria:

  • 18 years or older
  • You are the biological father of the baby (i.e., no donor sperm but fertility treatment allowed)
  • You are English or Spanish speaker
  • Mother of baby is also willing to participate

Aim 2 (fetal genetics)

  • Self-reported Black or African American
  • 18 years or older
  • Your gestational age is less than 20 weeks and 0 days (soon to be 24 weeks and 0 days)
  • You are English or Spanish speaker
  • You are having a single intrauterine pregnancy
  • You plan to deliver at the study site hospital

Aim 3 (Gestational diabetes/ GDM)

  • 18 years or older
  • You have been diagnosed with gestation diabetes
  • You are having a single intrauterine pregnancy
  • You are English or Spanish speaker
  • You plan to deliver at the study site hospital
  • You agree to be randomized into delivery windows starting at 37 weeks and 0 days

Ineligibility Information

Aim 3 (GDM):

  • You did not have diabetes prior to your pregnancy
  • You have not had any previous stillbirths greater than 20 weeks of gestation
  • You do not have a history of drug/alcohol abuse in the previous year
  • You do not have any infectious diseases that may affect the baby
  • Fetal demise
  • You are involved in another study that may affect the management of your labor
  • If you have any other condition or indication that could lead to early delivery