PregnancyHAPPYNCT05364346
HAPPY Study: Holistic Approach to Pregnancy and the First Postpartum Year
An observational study of Pregnancy, run by Tilburg University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- How many people
- 2,269 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Age: at least 18 years
- Caucasian women (or third generation women of other ethnic groups) who are able to complete Dutch questionnaires
- Singleton pregnancy
- Term of gestation at inclusion < 14 weeks only if the women did not have had their standard blood assessment
Who cannot join
- 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
About this study
Official title: The HAPPY Study: Holistic Approach to Pregnancy and the First Postpartum Year
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.
Read more
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.
Read the detailed description
Recruitment: Dutch-speaking Caucasian women (or third generation women of other ethnic groups) who have their first prenatal visit are eligible to participate in the study from the early beginning of their pregnancy. Eligible pregnant women (and their partner) receive written and oral information about the study at their first prenatal visit. If women decide to participate, written informed consent will be obtained. Written informed consent includes participation in the study and inclusion of all obstetric data from the medical record form of the community midwife and obstetrician (including ultrasound data), a detailed delivery description and neonatal condition, and data of newborn screening (heel prick test).
Sample size calculation: The total amount of pregnancies in the area of the 17 community midwife practices is about 5,000 per year. With 10-15% non-Caucasian, 10-15% early abortion rate and 1.7% gemelli pregnancies, approximately 3,700 pregnant women will be eligible annually. Based on previous pregnancy-related research experiences of the last 20 years in this area, the response rate is expected to be high (70%) especially when no additional blood tests or interventions have to be performed. This will result in about 2,600 inclusions annually. During pregnancy, the rate of women moving outside the area is in general low which means that a number of 2,500 women are expected to finish the study protocol until delivery. After a pilot period of three months followed by a running-in period of three months, it is estimated that all midwife practices will collaborate within six months. Therefore, the period of recruitment will take 18 months to include 2,600 women.
Because different types of events with different prevalence rates might interfere with the sample size needed for appropriate statistics, the number of 2,500 women is estimated to meet the standard epidemiological criteria. With 2,500 participants, the following numbers of abnormal events are estimated to be found: 108 women with a foetus in breech position (4.3%), 185 preterm births (7.4%), 450 women (18%) will develop depression during pregnancy and 325-475 women (13-19%) will develop postpartum depression during the first postpartum year. According to thyroid function, the investigators will find 200 (8%) women with elevated titres of thyroid peroxidase antibodies (TPO-Ab) and 100 with thyrotrophin (TSH) levels > 2.5 IU/l. These numbers will allow statistical analysis with sufficient power. With an expected prevalence rate of 4-10% (breech, preterm birth, TPO antibodies, TSH > 2.5), a significance level of 5% and a power of 80%, 1,500-2,140 women need to be included (depending on the expected prevalence rate). In order to anticipate on (low) drop out, 2,600 women will be included.
Data collection:
- Questionnaires (eight questionnaires during the period between 12 weeks gestation and 12 months postpartum)
- Obstetric record form
- Standardized 20 weeks ultrasound (SEO)
- Blood analysis of thyroid function and HCG. The Primary Care laboratory of Eindhoven (Diagnostics voor U) will be responsible for collection of the blood samples and the ultrasounds. The Laboratory of clinical chemistry and haematology of the Máxima Medical Centre Veldhoven is responsible for analysis of TSH, free-thyroxin (FT4), TPO-Ab and HCG and storage of the blood samples. Since the additional tube of blood will be drawn during the regular blood assessment (which already needs a venipuncture), and the umbilical cord and the placenta normally are thrown away for destruction after birth, it can be stated that there are no additional interventions performed to either mother or the newborn within the HAPPY study.
Ethical approval: The HAPPY study is approved by the Ethical Board of Tilburg University (with special attention to the type of questionnaires that are used) and has been evaluated by the Medical Ethical Committee of the Máxima Medical Centre Veldhoven. Because all additional blood samples were obtained during regular blood assessments as part of regular obstetric care, the board confirmed that no additional approval of a medical committee was needed.
- Conditions
- Pregnancy
- Keywords
- pregnancy-related symptoms, psychological distress, thyroid function, postpartum well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women in the area of South-East Brabant, The Netherlands |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
- changes in thyroid functioning over time during pregnancy
- investigate a possible independent effect of thyroid dysfunction on foetal development as assessed by a standardized ultrasound protocol at 18-22 weeks gestation
- effect of thyroid dysfunction on maternal mood
- effect of thyroid dysfunction on obstetric outcome
- impact of thyroid autoimmune disease on postpartum depression
Measured: 10-12 weeks an 26-30 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study startJan 2013
- Primary completionSep 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,269 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof.dr. Victor J Pop, Tilburg University
- Investigators
- Victor J Pop, MD, PhD, Principal investigator, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364346
- Sponsor's protocol ID
- HAPPY2014
- Acronym
- HAPPY
- Status last verified
- Apr 2022
- First submitted
- 13 Feb 2014
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HAPPY Study: Holistic Approach to Pregnancy and the First Postpartum Year
- ClinicalTrials.gov ID
- NCT05364346
- Acronym / sponsor ID
- HAPPY / HAPPY2014
- Conditions
- Pregnancy
- Keywords
- pregnancy-related symptoms, psychological distress, thyroid function, postpartum well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,269 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recruitment: Dutch-speaking Caucasian women (or third generation women of other ethnic groups) who have their first prenatal visit are eligible to participate in the study from the early beginning of their pregnancy. Eligible pregnant women (and their partner) receive written and oral information about the study at their first prenatal visit. If women decide to participate, written informed consent will be obtained. Written informed consent includes participation in the study and inclusion of all obstetric data from the medical record form of the community midwife and obstetrician (including ultrasound data), a detailed delivery description and neonatal condition, and data of newborn screening (heel prick test).
Sample size calculation: The total amount of pregnancies in the area of the 17 community midwife practices is about 5,000 per year. With 10-15% non-Caucasian, 10-15% early abortion rate and 1.7% gemelli pregnancies, approximately 3,700 pregnant women will be eligible annually. Based on previous pregnancy-related research experiences of the last 20 years in this area, the response rate is expected to be high (70%) especially when no additional blood tests or interventions have to be performed. This will result in about 2,600 inclusions annually. During pregnancy, the rate of women moving outside the area is in general low which means that a number of 2,500 women are expected to finish the study protocol until delivery. After a pilot period of three months followed by a running-in period of three months, it is estimated that all midwife practices will collaborate within six months. Therefore, the period of recruitment will take 18 months to include 2,600 women.
Because different types of events with different prevalence rates might interfere with the sample size needed for appropriate statistics, the number of 2,500 women is estimated to meet the standard epidemiological criteria. With 2,500 participants, the following numbers of abnormal events are estimated to be found: 108 women with a foetus in breech position (4.3%), 185 preterm births (7.4%), 450 women (18%) will develop depression during pregnancy and 325-475 women (13-19%) will develop postpartum depression during the first postpartum year. According to thyroid function, the investigators will find 200 (8%) women with elevated titres of thyroid peroxidase antibodies (TPO-Ab) and 100 with thyrotrophin (TSH) levels > 2.5 IU/l. These numbers will allow statistical analysis with sufficient power. With an expected prevalence rate of 4-10% (breech, preterm birth, TPO antibodies, TSH > 2.5), a significance level of 5% and a power of 80%, 1,500-2,140 women need to be included (depending on the expected prevalence rate). In order to anticipate on (low) drop out, 2,600 women will be included.
Data collection:
- Questionnaires (eight questionnaires during the period between 12 weeks gestation and 12 months postpartum)
- Obstetric record form
- Standardized 20 weeks ultrasound (SEO)
- Blood analysis of thyroid function and HCG. The Primary Care laboratory of Eindhoven (Diagnostics voor U) will be responsible for collection of the blood samples and the ultrasounds. The Laboratory of clinical chemistry and haematology of the Máxima Medical Centre Veldhoven is responsible for analysis of TSH, free-thyroxin (FT4), TPO-Ab and HCG and storage of the blood samples. Since the additional tube of blood will be drawn during the regular blood assessment (which already needs a venipuncture), and the umbilical cord and the placenta normally are thrown away for destruction after birth, it can be stated that there are no additional interventions performed to either mother or the newborn within the HAPPY study.
Ethical approval: The HAPPY study is approved by the Ethical Board of Tilburg University (with special attention to the type of questionnaires that are used) and has been evaluated by the Medical Ethical Committee of the Máxima Medical Centre Veldhoven. Because all additional blood samples were obtained during regular blood assessments as part of regular obstetric care, the board confirmed that no additional approval of a medical committee was needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women in the area of South-East Brabant, The Netherlands |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (4 listed)
- Age: at least 18 years
- Caucasian women (or third generation women of other ethnic groups) who are able to complete Dutch questionnaires
- Singleton pregnancy
- Term of gestation at inclusion < 14 weeks only if the women did not have had their standard blood assessment
Key exclusion criteria (7 listed)
- Gemelli pregnancy
- Endocrine disorder
- Use of thyroid medication
- Severe psychiatric disease (schizophrenia, borderline, or bipolar disorder)
- HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy-related signs and symptoms during pregnancy
Time frame: 12, 22, 32 weeks of gestation and 1 week postpartum
* 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
Maternal distress
Time frame: 12, 22, 32 weeks of gestation and postpartum at 1 week, 6 weeks, 4 months, 8 months and 1 year
* 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
1 secondary outcome
Thyroid function
Time frame: 10-12 weeks an 26-30 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor J Pop, MD, PhD principal investigator
Tilburg University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Tilburg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-related signs and symptoms during pregnancy (time frame: 12, 22, 32 weeks of gestation and 1 week postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.