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HAPPY Study: Holistic Approach to Pregnancy and the First Postpartum Year

NCT05364346 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2269

Last updated 2022-05-06

No results posted yet for this study

Summary

The HAPPY study is a large prospective longitudinal cohort study in which pregnant women (N≈2,500) are followed during the entire pregnancy and the whole first year postpartum. The study collects a substantial amount of psychological and biological data investigating all kinds of determinants that might interfere with general well-being during pregnancy and postpartum, with special attention to the effect of maternal mood, pregnancy-related somatic symptoms (including nausea and vomiting (NVP) and carpal tunnel syndrome (CTS) symptoms), thyroid function, and human chorionic gonadotropin (HCG) on pregnancy outcome of mother and foetus.

The primary aim of HAPPY concerning pregnancy is to measure the prevalence and changes of biological signs and symptoms over time, with special focus on NVP and CTS. Both a psychological and a biological model will be tested to explain the variance of (severe) NVP and CTS symptoms.

Also, the occurrence of maternal distress (anxiety and depression) will be assessed during different trimesters. Secondly, we will measure the changes in thyroid functioning over time during pregnancy and investigate a possible independent effect of thyroid dysfunction on foetal development as assessed by a standardized ultrasound protocol at 18-22 weeks gestation. Moreover, a possible independent effect of thyroid dysfunction on maternal mood will be investigated as well as on obstetric outcome including abnormal foetal position at term, the prevalence of preterm birth (\< 37 weeks of gestation) and its possible causes such as preterm premature rupture of membranes (PPROM), the occurrence of pre-eclampsia and other obstetric complications.

With regard to the postpartum period, the primary aim is to investigate the effect of chronic depression during pregnancy on postpartum recovery. Secondary outcome is the impact of thyroid autoimmune disease on postpartum depression. Tertiary outcome is the relation between psychological determinants and initiating and continuation of breastfeeding.

Conditions

  • Pregnancy

Sponsors & Collaborators

  • Tilburg University

    lead OTHER

Principal Investigators

  • Victor J Pop, MD, PhD · Tilburg University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364346 on ClinicalTrials.gov