Antenatal Stress and Infants In MAR
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Eugenio Medea
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Parents under 18 years of age.
Pregnancy achieved through heterologous assisted reproduction via donor sperm.
Pregnancy achieved without FIVET techniques.
Maternal hypertension during pregnancy.
Trial population
Couples from Lombardy, Italy, who conceived through medically assisted reproduction are recruited via fertility centers. The study includes first-trimester pregnant women and their male partners with singleton pregnancies.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Diagnostic procedures
Other interventionpsychological and biological multimodal assessment of stress
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Homologous fertilization group1 intervention
Group B: Heterologous fertilization group1 intervention
Trial outcomes
Primary outcomes
1
Maternal Anxiety
Levels of anxiety in mothers during pregnancy and at birth, measured using the STAI
Time frame
Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.2
Maternal Depression
Levels of depressive symptoms in mothers during pregnancy and at birth, measured using the EPDS
Time frame
Assessed in the 1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.3
Maternal salivary cortisol
Salivary cortisol levels measured at three time points across two consecutive days in late pregnancy, reflecting HPA axis
Time frame
3rd trimester (34th-36th week of pregnancy)4
Maternal salivary alpha amylase
Salivary alpha-amylase levels measured at three time points across two consecutive days in late pregnancy, reflecting sympathetic nervous system activity.
Time frame
3rd trimester (34th-36th week of pregnancy).Secondary outcomes
1
Pregnancy-Specific Distress (maternal)
Levels of pregnancy-related stress assessed using the NuPDQ questionnaire
Time frame
1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)2
Prenatal Emotional Availability
Quality of the mother's emotional availability and bonding with the fetus, measured using the Pre EA-SR questionnaire
Time frame
1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week)3
Perceived Social Support
Parental perception of support from family, friends, and significant others, measured using the MSPSS questionnaire.
Time frame
1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.4
Parental Self-Efficacy
General sense of self-efficacy assessed in both parents using the GSE questionnaire
Time frame
1st trimester (11th-13th week), 2nd trimester (22nd-24th week), 3rd trimester (34th-36th week), and at birth.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS Eugenio Medea
Lead sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborator
Source ClinicalTrials.gov