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

NCT05364346 | Completed

• 1 other identifier: HAPPY2014
• Study Type: observational
• Target: 2,269
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pregnancy-related symptoms; psychological distress; thyroid function; postpartum well-being

Outcome Measures

Primary Outcomes (2)

• Pregnancy-related signs and symptoms during pregnancy

  * Prevalences and changes of pregnancy-related symptoms like nausea and vomiting (NVP) and carpal tunnel syndrome (CTS) during pregnancy * Relation between psychological determinants and NVP * Relation between thyroid function, HCG and NVP * Relation between thyroid function and CTS

  12, 22, 32 weeks of gestation and 1 week postpartum

• Maternal distress

  * Prevalences and changes in maternal distress (anxiety and depression) during pregnancy and the first year postpartum * Relation between psychological determinants and initiating and continuation of breastfeeding

  12, 22, 32 weeks of gestation and postpartum at 1 week, 6 weeks, 4 months, 8 months and 1 year

Secondary Outcomes (1)

• Thyroid function

  10-12 weeks an 26-30 weeks of gestation

Study Arms (1)

Pregnant women

Pregnant women in the area of South-East Brabant, The Netherlands

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women

You may qualify if:

• Age: at least 18 years
• Caucasian women (or third generation women of other ethnic groups) who are able to complete Dutch questionnaires
• Singleton pregnancy

You may not qualify if:

• Gemelli pregnancy
• Endocrine disorder
• Use of thyroid medication
• Severe psychiatric disease (schizophrenia, borderline, or bipolar disorder)
• HIV
• Drug or alcohol addiction problems
• Any other disease resulting in treatment with drugs that are potentially adverse for the foetus and need careful follow-up during pregnancy

Sponsors & Collaborators

• Tilburg University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood analysis of thyroid function and HCG. TSH, FT4, TPO-Ab, and HCG will be measured in Li-heparin plasma using electrochemoluminescence assays.

Study Officials

• Victor J Pop, MD, PhD

  Tilburg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. Victor JM Pop

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: May 6, 2022
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2016
• Last Updated: May 6, 2022

Record last verified: 2022-04