Biophysical Profile in Preterm Pregnancies
Condition: Fetal Development
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate the fetal biophysical profile (BPP) scoring in
      pregnant women from 20 weeks-0 days' to 36 weeks-6 days' gestation. A biophysical profile
      (BPP) is a score that is intended to assess fetal well-being. This test will be performed
      within the expected time of the routine ultrasound exam.
    

Detailed description: 
      1. PURPOSE: To determine whether human fetal biophysical profile (BPP) scoring varies
           according to gestational age in preterm pregnancies.

        2. RATIONALE: Fetal BPP and non-stress tests (NST) are useful tools in the assessment of
           fetal well-being in term fetuses. While for NST it has been established that the
           criteria for reassuring well-being are less strict in premature fetuses below 32 weeks'
           gestation, the pattern of BPP scoring according to preterm gestational age has not been
           fully investigated. The investigators consider that in premature fetuses, a reassuring
           BPP scoring does not need to be as strict as that used in term fetuses.

        3. STUDY/PROJECT POPULATION:

           The Investigators' aim to use BPP scoring during routine ultrasound visits that pregnant
           patients undergo as part of their prenatal care. A routine ultrasound visit is performed
           during 30 to 60 minutes. The use of BPP will not add additional time to that taken by
           the routine ultrasound visit.

           The investigators will use BPP scoring in women from 20 to 36 weeks' gestation who
           attend routine ultrasound visits at the MedPlex Outpatient Clinic - Regional One Health.
           The sonographers are trained in the performance of BPP. The investigators will include
           women with singleton and multiple pregnancies who are able to provide informed consent.

           The investigators will exclude women who do not consent for the study, those unable to
           provide informed consent, and those with lethal fetal anomalies.

        4. RESEARCH DESIGN Descriptive study with prospective collection of data.

        5. STUDY/PROJECT PROCEDURES:

           The study will involve the performance of a biophysical profile (BPP) scoring during
           routine ultrasound exams. The BPP is not intended to last more than 30 minutes. A BPP
           score is composed by ultrasound assessment of:

             -  amniotic fluid volume (normal = 2 points, low = 0 points)

             -  fetal movements (3 or more movements = 2 points, less movements = 0 points); we
                will record the total number of movements during the testing period

             -  fetal breathing (sustained 30 second breathing = 2 points, <30 seconds = 0 points);
                we will record time of sustained breathing during the testing period

             -  fetal tone (extension and flexion = 2 points, lack of extension/flexion = 0 points)
                For those patients undergoing standard of care scheduled BPP, information will be
                abstracted from the scheduled test.

           For those patients undergoing standard of care ultrasound but are not scheduled for BPP,
           additional BPP will be obtained within the time allotted for the already scheduled
           ultrasound.

           The investigators will correlate the BPP scoring with the non-stress test (NST) or
           Doppler flow reports in those fetuses already undergoing NST or Doppler studies for
           other obstetric indications not related to the purpose of this study.

        6. OUTCOME MEASURES:

      Primary outcome: fetal or neonatal survival

      Secondary outcomes:

        -  gestational age at delivery

        -  need for NST

        -  hospitalization

        -  need for antenatal steroids use

        -  fetal growth restriction

        -  spontaneous or indicated preterm delivery

        -  neonate apgars

        -  neonatal morbidity: respiratory, gastrointestinal, neurologic, metabolic
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant patients that meet the all of the inclusion criteria and do not meet the exclusion
        criteria, will be approached during their routine prenatal care regarding their interest in
        participation. Women must be between 20 weeks to 36 weeks of their pregnancy.
      
Keywords: Fetal Biophysical Profile