title: Prenatal recruitment of participants for a birth cohort study including cord blood collection: results of a feasibility study in Bremen, Germany.
abstract: BACKGROUND
  Prospective birth cohort studies comprising follow up of children from pregnancy or birth over a long period of time, and collecting various biological samples at different times through the life-course offer a promising approach to enhance etiologic knowledge of various diseases. Especially for those where early lifetime exposures and conditions are thought to play an important role. The collection and storage of biological samples is a critical component in epidemiological studies, notably for research regarding prenatal exposures to various environmental factors as well as for DNA extraction. Our feasibility study for a birth cohort within the scope of etiology of childhood leukemia with prospective sampling of mothers and their future newborns aimed to investigate the willingness of pregnant women to participate in a birth cohort study involving collection of blood and umbilical cord blood samples. The overall aim was to develop practice-based research recommendations for a possible German birth cohort study.
  
  
  METHODS
  The study was conducted in Bremen, Germany, between January 2012 and March 2013. Pregnant women were eligible for recruitment if (i) their expected date of delivery was during the study recruitment phase (September 2012-February 2013), (ii) they planned to give birth at the cooperating hospital's obstetric unit and (iii) their knowledge of the German language was sufficient to understand study materials, details of participation and to fill out the prenatal self-administered questionnaire. Maternal blood and umbilical cord blood samples to be used for later research activities were collected and stored at a stem cell bank already collaborating with the hospital. 22 primary care gynecologists were invited to enroll pregnant women for the study and cooperation with one hospital was established. Expectant women were recruited during the last trimester of pregnancy, either during one of their prenatal care visits at their primary care gynecologist or later on in hospital by the attending obstetricians or project staff.
  
  
  RESULTS
  Of the 22 invited primary care gynecologists requested to enroll pregnant women for the study, 8 gynecologists actually collaborated. A total of 200 eligible women were invited to participate in the study, 48 (24%) of whom agreed. 34 women were enrolled by primary care gynecologists, with one gynecologist enrolling 26 women. Twelve of 14 women recruited via hospitals were enrolled by study staff. A total of 41 women consented to the collection of umbilical cord blood and maternal blood samples, and samples could be stored for 54% of them. Reason for non-participation were the uncertainty whether or not the full study would be conducted and the fact that the participants were not willing to decide for their children whether or not genetic information (cord blood) can be stored for research purposes.
  
  
  CONCLUSIONS
  Enrolling parents in a birth cohort study that includes biosampling is a challenge, but participation can be improved through close collaboration with primary care gynecologists and maternity hospitals. Cord blood collection may impede participation, especially when maternity hospitals offer an alternative option for cord blood donation.
authors.affiliation: Leibniz-Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
authors.forename: Sinja Alexandra
authors.initials: SA
authors.lastname: Ernst
authors.affiliation: Leibniz-Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Günther
authors.affiliation: St. Joseph-Stift Krankenhaus, Bremen, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Frambach
authors.affiliation: Leibniz-Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
authors.forename: Hajo
authors.initials: H
authors.lastname: Zeeb
mesh_terms: D000328:Adult; D001800:Blood Specimen Collection; D015331:Cohort Studies; D003299:Cooperative Behavior; D005240:Feasibility Studies; D005260:Female; D005312:Fetal Blood; D005858:Germany / Q000453:epidemiology; D006176:Gynecology / Q000191:economics; D006801:Humans; D007231:Infant, Newborn; D007938:Leukemia / Q000453:epidemiology* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D008880:Midwifery / Q000191:economics; D009042:Motivation; D018579:Patient Selection; D011247:Pregnancy; D011263:Pregnancy Trimester, Third; D011446:Prospective Studies; D055815:Young Adult
keywords: birth cohort study; children; feasibility study; leukemia; umbilical cord blood