Table 4.
Breakdown of cases by final adjudicated diagnosis and Congo Red test result by site of recruitment.
| Clinical Diagnosis | Adjudicated diagnosis | Congo Red test result | Case notes | ||
|---|---|---|---|---|---|
| Bangladesh | |||||
| CONTROL N = 98 |
NO PE n = 81 |
NO, n = 70 True negative YES, n = 11 False positive |
Unanimous concordance ruling out PE. Cases in this category underwent medically indicated delivery due to prior c/s. All tested weak positive. |
||
| Other co-morbid conditions (n = 17) | NO, n = 9 True negative YES, n = 8 False positive |
CRD concurred with adjudicated diagnosis. Cases included severe oligohydramnios (n = 1), case with history of hypertension and heart disease (n = 1), gestHT without a diagnosis of PE, medically indicated delivery for reduced fetal movement (n = 1). All 8 cases tested weak positive. |
|||
| CASE N = 98 |
NO PE n = 8 |
NO=1 True negative YES=7 False positive |
CRD concurred with adjudicated diagnosis of chronic hypertension while managing team's call was preeclampsia, uncategorized. Case adjudications was gestational hypertension (n = 1) while managing team's diagnosis was severe preeclampsia. Case adjudication was atypical PE or PE mimics (n = 2) while managing team's diagnosis was eclampsia. Case adjudication was idiopathic isolated proteinuria (n = 4) while the managing team's diagnosis was sPE, HELLP and PE uncategorized. All 7 cases tested weak positive. |
||
| YES PE n = 90 |
NO, n = 14 False negative YES, n = 76 True positive |
Case adjudication was sPE no PLTC (n = 5) and sPE with PLTC (n = 9) including a maternal death due to cardiac arrest. 5 had history of eclampsia prior to admission. 6 underwent MIDPE. 7 with a GA <34 weeks. Unanimous concordance ruling in PE. |
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| Mexico | |||||
| CONTROL N = 107 |
NO PE n = 92 |
NO, n = 69 True negative YES, n = 23 False positive |
Unanimous concordance ruling out PE. Included cases with medically indicated delivery for failure to progress (n = 3), PROM (n = 1), CPD (n = 1) and short inter-pregnancy interval (n = 1). One case experienced a pph and one case with diabetes. |
||
| Other co-morbid conditions (n = 11) | NO, n = 10 True negative YES, n = 1 False positive |
CR test concurred with adjudicated diagnosis. Adjudicated diagnoses were hypertension (n = 4), oligohydramnios (n = 5) or abruption (n = 1). Case with weak positive test underwent medically indicated delivery for oligohydramonius. |
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| Unclassifiable (unknown BP) (n = 4) | NO, n = 3 YES, n = 1 |
Unknown BP at time of delivery and inadequate clinical data to rule out other co-morbid conditions or PE. | |||
| CASE N = 106 |
NO PE n = 41 |
NO, n = 28 True negative YES, n = 13 False positive |
CR test concurred with adjudicated diagnosis. Adjudicated diagnosis was of gestHTN (n = 17), amPE without PLTC (n = 4), IDP (n = 4) or no PE criteria (n = 3) while managing team's call was of mPE, SPE or uncategorized PE. 17 cases underwent MIDPE. Adjudicated diagnosis included gestHTN (n = 5), amPE with PLTC (n = 1), amPE without pLTC (n = 1), IDP (n = 5) and no PE criteria (n = 1). The three cases with a strong positive result (E) had an adjudicated diagnosis of idiopathic proteinuria. |
||
| Yes PE n = 65 |
NO, n = 27 False negative YES, n = 38 True positive |
Cases included mPE (n = 8), SPE without PLTC (n = 13), SPE with PLTC (n = 3), spPE (n = 3). Unanimous concordance ruling in PE |
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*Positive test defined as score C-F. SPE = severe preeclampsia, PLTC=preeclampsia-related life threatening conditions, gestHTN=gestational hypertension, spPE=superimposed preeclampsia, amPE=atypical preeclampsia or preeclampsia mimic, MIDPE=medically indicated delivery for preeclampsia, PROM=premature rupture of membranes; CPD= Cephalopelvic disproportion.