Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/11/2008
Date assigned
20/04/2009
Last edited
17/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
An allergy is a reaction the body has to a particular food or substance. The aim of this study is to find out whether endocrine (hormone) and immune system alterations and nutrition during pregnancy influence the child’s risk of developing an allergic disease.

Who can participate?
Women aged between 18 - 35 with a single-child pregnancy (gestational age 8 - 12 weeks)

What does the study involve?
The participants’ medical, obstetrical and gynaecological history is thoroughly documented, and sociodemographic data (including smoking habits of pregnant mother and her partner) is collected. In addition, a stress evaluation is performed using questionnaires. Living conditions (including smoking habits, work life, vaginal infections, housing, decorating activities, etc) are investigated using a questionnaire. Blood samples are taken from the prospective mothers and analysed. A second visit is arranged at a gestational age of 20 - 24 weeks, when a regular pregnancy check-up is also scheduled. Here, the psychological evaluation is repeated and the living conditions are again documented. In addition, the women are asked to fill out a questionnaire on dietary habits over the past 3 months. Blood samples are taken again and analysed. The women are asked to return a postage-paid pregnancy outcome card to us once their baby is born. A year after birth, the children are invited for a clinical visit at our study centres. Here we examine the children for clinical symptoms of atopic dermatitis (a skin condition). Then, once every year, in the month of the child's birthday, a questionnaire is mailed to the parents to document the incidence of allergic diseases in the child. Detailed information is requested on the child's vaccination history, presence of in-house pets or smokers, upbringing in urban or rural environment. This thorough documentation is repeated until the child is five years old.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Charité, Campus Virchow Klinikum (Germany)

When is the study starting and how long is it expected to run for?
October 2009 to October 2017

Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Who is the main contact?
Dr Maike Pincus

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maike Pincus

ORCID ID

Contact details

Charité
Campus Virchow Klinikum
Klinik fuer Paediatrie mit Schwerpunkt Pneumologie und Immunologie
Augustenburger Platz 1
Berlin
13353
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI 877/1-1

Study information

Scientific title

Foetal Programming of Allergic Diseases: an observational multicentre pregnancy cohort study

Acronym

FePAD

Study hypothesis

Endocrine and immune alterations as well as nutrition during pregnancy influences the individual risk for the child to develop an allergic disease.

Ethics approval

1. Charite, Campus Virchow Klinikum Ethikkomission (Germany), 16/05/2006 and 04/11/2008, ref: EA2/030/06
2. St. Joseph's Research Ethics Board (Canada), 20/12/2007, ref: 07-2929

Study design

Observational multicentre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Allergic diseases, e.g., atopic dermatitis, asthma and allergic rhinoconjuncitvitis

Intervention

After written informed consent, the medical, obstetrical and gynaecological history will be thoroughly documented, and sociodemographic data (including smoking habits of pregnant mother and her partner) will be collected. In addition, stress evaluation will be performed employing standardised questionnaires on psychosocial and emotional functioning. Here, validated questionnaires will be employed. Living conditions (including smoking habits, work life, vaginal infections, housing, decorating activities, etc.) will be investigated by a published and validated questionnaire.

Further, blood will be drawn from the prospective mothers and analysed with respect to the endocrine-immune profile.

A second visit is envisaged at a gestational age of 20 - 24 weeks, where a regular pregnancy check up is also scheduled. Here, the psychometric evaluation will be repeated and the living conditions will again be documented. In addition, the women will be asked to fill out an established questionnaire on dietary habits over the past 3 months. Furthermore, blood will be drawn again and endocrine-immune parameters will be analysed.

For the follow-up after birth, a postage-paid pregnancy outcome card will be placed in the pregnancy pass. The women will be asked to return this card to us once their baby is born. A year after birth, the children will be invited for a clinical visit at our study centres. Here we will examine the children for clinical symptoms of atopic dermatitis and scoring the symptoms with a clinical score.

Then, once every year, in the month of the child's birthday, a questionnaire will be mailed to the parents to document the incidence of allergic diseases in the child. Further, detailed information on the child's vaccination history, presence of in-house pets or smokers, upbringing in urban or rural environment will be requested. This thorough documentation is planned to be repeated until the child is five years old.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Evaluation of environmental cues as further potential risk factors during pregnancy (e.g. living conditions, smoking habits, perceived stress, social support and nutrition) for the child's risk to develop an atopic disease.

Secondary outcome measures

Investigation of potential mechanism, by which environmental cues may exert a foetal programming effect towards allergic diseases during pregnancy. Here we will concentrate on endocrine, immune and neurobiological mechanisms.

Overall trial start date

01/10/2009

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women recruited at a gestational age of 8 - 12 weeks
2. Aged between 18 and 35 years old
3. Single child pregnancy
4. Full-term deliveries

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1300

Participant exclusion criteria

1. Fertility treatments and infections (human immunodeficiency virus [HIV], hepatitis B and C)
2. A history of recurrent spontaneous abortion, pre-eclampsia, or gestational diabetes in previous pregnancies
3. Sufferers of the following chronic diseases:
3.1. Inflammatory bowel diseases
3.2. Diabetes type 1
3.3. Rheumatoid and autoimmune diseases
3.4. Previous chemotherapies and radiation therapies

Recruitment start date

01/10/2009

Recruitment end date

01/10/2017

Locations

Countries of recruitment

Canada, Germany

Trial participating centre

Charité, Campus Virchow Klinikum
Berlin
13353
Germany

Sponsor information

Organisation

Individual sponsor (Germany)

Sponsor details

Dr Maike Pincus
Charité
Campus Virchow Klinikum
Klinik fuer Paediatrie mit Schwerpunkt Pneumologie und Immunologie
Augustenburger Platz 1
Berlin
D-13353
Germany

Sponsor type

Other

Website

Funders

Funder type

Research council

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/03/2016: Plain English summary added.