Pregnancy Information



To be completed by female participants/subjects only.Date pregnancy information obtained:Is the participant/subject pregnant? FORMCHECKBOX Yes FORMCHECKBOX No (Skip to Q8) FORMCHECKBOX Unknown (Skip to Q8)Current PregnancyWas birth control being used? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf Yes, indicate all forms of contraception used (choose all that apply): FORMCHECKBOX Oral contraceptives–combined pill (“the pill”) FORMCHECKBOX Oral contraceptives–progestin-only pill (“mini-pill”) FORMCHECKBOX Transdermal patch (i.e., Ortho Evra) FORMCHECKBOX Shot/injection (i.e., Depo-Provera) FORMCHECKBOX Vaginal ring (i.e., NuvaRing) FORMCHECKBOX Implantable devices with hormone (i.e., ParaGuard, Mirena) FORMCHECKBOX Abstinence FORMCHECKBOX None of theseLast date birth control used:Date of last menstrual period:Date pregnancy confirmed:Estimated delivery date (EDD):Was the EDD based on an ultrasound? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownWas prenatal testing performed? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf Yes, please complete the following questions regarding prenatal testing: SEQ Table \* ARABIC 1: Pregnancy Information TablePrenatal TestDate(s) of TestingResults of TestCommentsUltrasoundAmniocentesisScreening for neural tube defectsScreening for gestational diabetes before or at 28 weeksScreening for asymptomatic bacteriuria before or at 16 weeks gestationHepatitis B specific antigen screening at first visitHIV screening at first visitGroup B streptococcus screening (GBS) at 35 to 37 weeksMaternal serum alpha fetoproteinOther, specify:Did/Has the participant/subject experienced any complications during this pregnancy? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf Yes, specify:Did/Has the participant/subject experienced any infections or illnesses during this pregnancy? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf Yes, specify:Pregnancy HistoryHas the participant/subject ever been pregnant? FORMCHECKBOX Yes FORMCHECKBOX No (STOP) FORMCHECKBOX Unknown (STOP)Prior pregnancy (both to term and not to term):Number of prior pregnancies:Full-term (≥ 37 weeks) births:Pre-term (< 37 weeks) births:Did a birth defect occur in any previous pregnancy? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf Yes, specify birth defect:Did a miscarriage (≤ 20 weeks) or stillbirth (> 20 weeks) occur in any previous pregnancy? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownIf Yes, in what week of pregnancy did the miscarriage or stillbirth occur? week(s):Has the participant/subject ever had exposure to any of the following during pregnancy? FORMCHECKBOX Concurrent medication FORMCHECKBOX Exposure to X-ray FORMCHECKBOX Teratogens FORMCHECKBOX Alcohol FORMCHECKBOX Smoking FORMCHECKBOX Other specify:General InstructionsThis case report form (CRF) contains data elements related to pregnancy and should only be completed by females. It is important to be very explicit and detailed when completing this form to ensure the relevant and accurate data is collected. All items on this CRF are Exploratory. Specific InstructionsPlease see the Data Dictionary for definitions for each of the data elements included in this CRF Module.Date/Time–Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).Is this participant/subject pregnant?–No additional instructionsWas birth control being used?If Yes, indicate all forms of contraception used/last date used–Choose all that applyDate of last menstrual period–No additional instructionsDate pregnancy confirmed–No additional instructionsEstimated delivery date (EDD)/ Was the EDD based on an ultrasound?–No additional instructionsWas prenatal testing performed?/If Yes, please complete the following questions regarding prenatal testing–No additional instructionsDid/Has the participant/subject experienced any complications during this pregnancy?–No additional instructionsDid/Has the participant/subject experienced any infections or illnesses during this pregnancy?–No additional instructionsHas the participant/subject ever been pregnant?–No additional instructionsPrior pregnancy–Complete information for both to term and not to termDid a birth defect occur in any previous pregnancy?–No additional instructionsDid a miscarriage (≤ 20 weeks) or stillbirth (> 20 weeks) occur in any previouspregnancy?–No additional instructionsIf Yes, in what week of pregnancy did the miscarriage or stillbirth occur?–Record in week(s)Has the participant/subject ever had exposure to any of the following during pregnancy?–No additional instructions ................
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