Health Condition 1: O099- Supervision of high risk pregnancy, unspecified Health Condition 2: O149- Unspecified pre-eclampsia
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
The Gates Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women between 18 â?? 40 years of age. 2. Live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat. 3. Intended to deliver within a facility
Exclusion criteria
Exclusion criteria: 1. Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.) 2. Inability to obtain any high quality retinal imaging with Optos (i.e., extremely small pupil size, corneal opacities, dense cataracts, vitreous hemorrhage). If one eye is able to be imaged (such as monocular after trauma), this is not viewed as an exclusion. If only Optos wide-field is able to be obtained (such as may happen with small pupil with Remidio), this is not viewed as an exclusion. If a participant is unable to acquire any OPTOS images (better for small pupil than Remidio), she will be deemed ineligible for this study. The number of participants who are not able to be captured by OPTOS is expected to be small, and will be tracked. 3. Unable to provide informed consent, as deemed by site PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypertensive disorders of pregnancy (HDP) and Preeclampsia (PEC)Timepoint: Time 1 12 weeks +/- 1 week Time 2 20 weeks +/-1 week Time 3 28 0/7 weeks to 32 and 6/7 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Gestational hypertensionTimepoint: New onset after 20 weeks without the development of proteinuria;Severe preeclampsiaTimepoint: New onset after 20 weeks without the development of proteinuria;Early Onset PreeclampsiaTimepoint: before 34 weeks GA;Gestational diabetesTimepoint: Anytime during pregnancy;Vaginal bleeding and /or Antepartum hemorrhage Timepoint: Anytime during pregnancy;Postpartum hemorrhageTimepoint: After delivery before 6 weeks postpartum;Postpartum hypertensionTimepoint: After delivery before 6 weeks postpartum;Postpartum infectionTimepoint: After delivery before 6 weeks postpartum;Postpartum stroke or heart failureTimepoint: After delivery before 6 weeks postpartum;Postpartum readmissionTimepoint: After delivery before 6 weeks postpartum;Maternal mortalityTimepoint: Form conception till 6 weeks partum.;Late abortionTimepoint: After 20 weeks till 28 weeks GA;Change in maternal hemoglobinTimepoint: Anytime during pregnancy;Transfer to a higher level of careTimepoint: Anytime during pregnancy and postpartum till 6 weeks;Perinatal mortalityTimepoint: From 28 weeks GA till 1 weeks post partum;Birth weight less than 2500g and less than 1500g Timepoint: At delivery;Fetal loss or Spontaneous abortion Timepoint: At delivery;Still birthTimepoint: at delivery;Medical termination of pregnancy Timepoint: At delivery | — |
Countries
India
Contacts
Public ContactDr Mrityunjay Metgud
Jawaharlal Nehru Medical College
Outcome results
None listed