Antenatal Stress and Infants In MAR

Официальное название

The Effects of Antenatal Stress on the Newborn in Medically Assisted Reproduction: the SARA Study

Обзор

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)

Подробное описание

This observational, longitudinal, and multidisciplinary study investigates how prenatal psychological and biological stress affects neonatal outcomes in couples who conceived through medically assisted reproduction. The study employs a cross-fostering design, comparing mother-infant diads who are genetically related with those who are not. This allows researchers to distinguish the effects of prenatal stress from genetic influences. Data from this study may also be compared with findings from a previous study by our research group ("EDI Study"; Nazzari et al., 2019, 2020a, 2020b) for common objectives. The study is non-commercial and conducted on a not-for-profit basis.

Participants are recruited through fertility centers, where physicians present the study to prospective parents during routine visits, supported by brochures and informational materials.

Mothers undergo an initial screening using the Quick SCID-5 to exclude psychiatric disorders other than anxiety and depression, and complete a health questionnaire to assess physical status during pregnancy.

Eligible mothers and fathers then participate in several phases of data collection throughout pregnancy and at birth. Both parents complete online questionnaires assessing anxiety, depressive symptoms, perceived social support, and general self-efficacy. Mothers additionally complete pregnancy-specific measures, including the NuPDQ to evaluate prenatal distress and the Pre EA-SR to assess prenatal emotional availability and bonding with the fetus. In the third trimester, mothers also collect saliva samples at three points during the day across two consecutive days to measure stress-related biological markers (cortisol and alpha-amylase).

At birth, neonatal outcomes-including gestational age, weight, length, head circumference, and any perinatal complications-are recorded. Mothers also provide information about the impact of medically assisted reproduction on daily life and the psychological support they received during pregnancy.

The enrollment period for each participant lasts approximately 8 months, from recruitment in the first two months of pregnancy until childbirth. The overall study duration is 36 months.

Data analysis will employ multiple regression and hierarchical linear models to account for both primary and secondary outcomes and handle missing data appropriately.

This study will provide valuable insights into how prenatal stress manifests behaviorally, psychologically, and physiologically in parents who have undergone assisted reproduction and how it relates to neonatal outcomes. Findings could inform early interventions to support families in these populations from the very first stages of pregnancy.

Вмешательства

• Другое Diagnostic procedures
  psychological and biological multimodal assessment of stress

Первичные конечные точки

• Maternal Anxiety [Срок оценки: Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.]
• Maternal Depression [Срок оценки: Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.]
• Maternal salivary cortisol [Срок оценки: 3rd trimester (34th-36th week of pregnancy)]
• Maternal salivary alpha amylase [Срок оценки: 3rd trimester (34th-36th week of pregnancy).]
• Paternal Anxiety [Срок оценки: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth]
• Paternal depression [Срок оценки: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.]
• Neonatal Outcomes [Срок оценки: At birth]

Вторичные конечные точки (5)

• Pregnancy-Specific Distress (maternal) [Срок оценки: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)]
• Prenatal Emotional Availability [Срок оценки: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)]
• Perceived Social Support [Срок оценки: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.]
• Parental Self-Efficacy [Срок оценки: 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.]
• Infertility-Related Experiences and Psychological Support [Срок оценки: 3rd trimester (34th-36th week]

Критерии участия

Критерии включения

• Pregnant women in the first trimester and their respective partners.
• Pregnancy achieved through homologous assisted reproduction techniques.
• Pregnancy achieved through heterologous assisted reproduction via oocyte donation.
• Singleton pregnancy.
• Pregnancy achieved through FIVET techniques.

Критерии исключения

• Parents under 18 years of age.
• Pregnancy achieved through heterologous assisted reproduction via donor sperm.
• Pregnancy achieved without FIVET techniques.
• Maternal hypertension during pregnancy.
• Endocrine or immune system disorders during pregnancy.
• Chronic use of medications during pregnancy (including anti-inflammatory drugs, antidepressants, or steroids).
• Alcohol or substance abuse.
• Smoking during pregnancy.
• Psychiatric disorders other than anxiety or depression.
• Pregnancy or perinatal complications.
• Multiple pregnancy (twins or higher-order multiples).
• Preterm birth (before 35 weeks of gestation).
• Health problems in the newborn at birth.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 1 центр

• Ospedale Papa Giovanni XXIII — Bergamo

Публикации

• Yang Z, Wang X, Wang M, Yan S, Wu F, Zhang F. Trajectory of prenatal anxiety and depression and its association with fetal growth development. Early Hum Dev. 2023 Dec;187:105875. doi: 10.1016/j.earlhumdev.2023.105875. Epub 2023 Oct 17. PMID 37866288
• Salevaara M, Punamaki RL, Unkila-Kallio L, Vanska M, Tulppala M, Tiitinen A. The mental health of mothers and fathers during pregnancy and early parenthood after successful oocyte donation treatment: A nested case-control study. Acta Obstet Gynecol Scand. 2018 Dec;97(12):1478-1485. doi: 10.1111/aogs.13421. Epub 2018 Aug 6. PMID 29975790
• Rice F, Harold GT, Boivin J, van den Bree M, Hay DF, Thapar A. The links between prenatal stress and offspring development and psychopathology: disentangling environmental and inherited influences. Psychol Med. 2010 Feb;40(2):335-45. doi: 10.1017/S0033291709005911. Epub 2009 May 29. PMID 19476689
• Nazzari S, Fearon P, Rice F, Dottori N, Ciceri F, Molteni M, Frigerio A. Beyond the HPA-axis: Exploring maternal prenatal influences on birth outcomes and stress reactivity. Psychoneuroendocrinology. 2019 Mar;101:253-262. doi: 10.1016/j.psyneuen.2018.11.018. Epub 2018 Nov 14. PMID 30497017
• Mascarenhas M, Sunkara SK, Antonisamy B, Kamath MS. Higher risk of preterm birth and low birth weight following oocyte donation: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Nov;218:60-67. doi: 10.1016/j.ejogrb.2017.09.015. Epub 2017 Sep 19. PMID 28942045
• Lobel M, Cannella DL, Graham JE, DeVincent C, Schneider J, Meyer BA. Pregnancy-specific stress, prenatal health behaviors, and birth outcomes. Health Psychol. 2008 Sep;27(5):604-15. doi: 10.1037/a0013242. PMID 18823187
• Gilles M, Otto H, Wolf IAC, Scharnholz B, Peus V, Schredl M, Sutterlin MW, Witt SH, Rietschel M, Laucht M, Deuschle M. Maternal hypothalamus-pituitary-adrenal (HPA) system activity and stress during pregnancy: Effects on gestational age and infant's anthropometric measures at birth. Psychoneuroendocrinology. 2018 Aug;94:152-161. doi: 10.1016/j.psyneuen.2018.04.022. Epub 2018 Apr 22. PMID 29783163
• Garcia-Blanco A, Diago V, Hervas D, Ghosn F, Vento M, Chafer-Pericas C. Anxiety and depressive symptoms, and stress biomarkers in pregnant women after in vitro fertilization: a prospective cohort study. Hum Reprod. 2018 Jul 1;33(7):1237-1246. doi: 10.1093/humrep/dey109. PMID 29796614

Идентификаторы

NCT: NCT07408453 · 222/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗