Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound
Condition: Pregnancy Early
Study type: Observational

Summary: 
      The objective of this study is to assess equivalency of the transabdominal Clarius handheld
      wifi C3 ultrasound (which uses Bluetooth to locate the ipad Mini 5 and then uses wifi direct
      to show the images) to the current standard of care in Women's Hospital outpatient department
      the portable Zonare ZS3 in patients presenting in the first trimester of pregnancy.
    

Detailed description: 
      This is a prospective study in which first trimester participants who are presenting to
      discuss termination of pregnancy, will consent to have an additional transabdominal
      ultrasound with the Clarius C3 immediately prior to their standard ultrasound which is
      performed to date their pregnancy. Participants who are presenting for medical abortion have
      been prescreened to be estimated to be less than 9 weeks GA. Participants who are being seen
      prior to surgical abortion will have been screened by nurses based on their last menstrual
      period or estimated time of conception to estimate their gestational age. Potential
      participants estimated to be less than 13 weeks GA, will be approached to see if they are
      interested in participating in the study before they are seen by their health care provider.
      The name, date of approach, and reason for decline of potential participants who refuse to
      participate will be documented. If agreeable, the participant will complete consent with a
      study nurse or medical student for the additional ultrasound.

      Participants will then receive the 2 ultrasounds by the same health care provider with the
      Clarius C3 ultrasound first, then the standard care ultrasound. Occasionally, there may be a
      different provider doing the Clarius C3 ultrasound when the patient consents.

      Participants will receive standard care for medical or surgical abortion. The following
      information will be documented from their chart:

      Height and weight, age, Obstetrical history (Gravida, para, number cesareans, ectopic
      pregnancies, spontaneous abortions, therapeutic abortions). If they do not have a documented
      intrauterine pregnancy, the standard questions to rule out possibility of ectopic pregnancy
      will be determined, and any positive answers will be documented in the chart. Anyone without
      a documented intrauterine pregnancy (no gestational sac or a gestational sac with no definite
      crown rump length or yolk sac) will be followed until a final outcome is determined or they
      are lost to follow up. When the patient has a pregnancy of unknown location (no evidence of a
      pregnancy inside or outside of the uterus), their data will not be used to compare the two
      ultrasounds but future outcome will be recorded.

      The final outcome of their pregnancy and any complications will be determined within the next
      6 weeks with the following potential outcomes:

      completed medical abortion, completed surgical abortion (possibily following failed medical
      abortion), lost to follow up, continuing pregnancy, or ectopic pregnancy.

      If a participant is determined to be over 13 weeks GA, they will receive a dating ultrasound
      with the Clarius C3 ultrasound using biparietal diameter as appropriate but it will not be
      included in the final study measurements.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients are presenting for an ultrasound prior to first trimester termination of
        pregnancy.
      
Keywords: Ultrasound; pregnancy; first trimester; dating