Antenatal Stress and Infants In MAR

Condition(s) studied

Investigational drug(s) / intervention(s)

Diagnostic procedures: psychological and biological multimodal assessment of stress

Study summary

The goal of this observational longitudinal study is to examine the association between prenatal psychological and biological stress and neonatal health outcomes in couples who conceived through medically assisted reproduction. The study includes expectant mothers and fathers during pregnancy and at birth and focuses on pregnancies achieved through homologous fertilization and heterologous fertilization via oocyte donation.

The main questions this study aims to answer are:

1. How do psychological and biological indicators of stress manifest during pregnancy in women who have undergone medically assisted reproduction?
2. Is prenatal maternal stress associated with neonatal health outcomes independently of genetic factors?
3. How does perceived stress present in expectant fathers during pregnancy? Researchers will compare couples who conceived through homologous fertilization with couples who conceived through heterologous fertilization via oocyte donation to understand whether associations between prenatal maternal stress and neonatal outcomes are independent of shared genetic background.

Participants will:

* Complete a remote eligibility assessment collecting information on pregnancy characteristics, parental health, and maternal psychological well-being
* Complete online questionnaires at multiple time points during pregnancy and at birth assessing anxiety and depressive symptoms, perceived social support, and self-efficacy (both parents), as well as pregnancy-specific measures and prenatal bonding (mothers only)
* In late pregnancy, mothers will collect saliva samples at home over two consecutive days to assess biological markers of stress (cortisol and alpha-amylase)

Eligibility

Primary outcome measure(s)

• Maternal Anxiety — Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
  Levels of anxiety in mothers during pregnancy and at birth, measured using the STAI
• Maternal Depression — Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
  Levels of depressive symptoms in mothers during pregnancy and at birth, measured using the EPDS
• Maternal salivary cortisol — 3rd trimester (34th-36th week of pregnancy)
  Salivary cortisol levels measured at three time points across two consecutive days in late pregnancy, reflecting HPA axis
• Maternal salivary alpha amylase — 3rd trimester (34th-36th week of pregnancy).
  Salivary alpha-amylase levels measured at three time points across two consecutive days in late pregnancy, reflecting sympathetic nervous system activity.
• Paternal Anxiety — 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth
  Levels of anxiety during pregnancy and at birth measured using the STAI
• Paternal depression — 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.
  Levels of depressive symptoms in fathers during pregnancy and at birth, measured using the EPDS
• Neonatal Outcomes — At birth
  Gestational age, birth weight, length, head circumference, and any perinatal complications recorded at birth.

Trial sites (1)

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