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    HP:0003811: Neonatal death

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (3)


    Name (Synonyms) Correlation
    drug4857 blood donation SMS Wiki 0.58
    drug453 Azithromycin Wiki 0.16
    drug3195 Placebo Wiki 0.04

    Correlated MeSH Terms (9)


    Name (Synonyms) Correlation
    D011645 Puerperal Infection NIH 1.00
    D063130 Maternal Death NIH 1.00
    D000071074 Neonatal Sepsis NIH 1.00
    Name (Synonyms) Correlation
    D066087 Perinatal Death NIH 1.00
    D011251 Pregnancy Complications, Infectious NIH 0.58
    D003643 Death, NIH 0.50
    D014115 Toxemia NIH 0.38
    D018805 Sepsis NIH 0.32
    D007239 Infection NIH 0.05

    Correlated HPO Terms (2)


    Name (Synonyms) Correlation
    HP:0040187 Neonatal sepsis HPO 1.00
    HP:0100806 Sepsis HPO 0.32

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

    Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

    NCT03871491
    Conditions
    1. Maternal Death
    2. Maternal Infections Affecting Fetus or Newborn
    3. Neonatal SEPSIS
    4. Maternal Sepsis During Labor
    5. Neonatal Death
    6. Postpartum Sepsis
    Interventions
    1. Drug: Azithromycin
    2. Drug: Placebo
    MeSH:Infection Sepsis Toxemia Neonatal Sepsis Pregnancy Complications, Infectious Puerperal Infection Perinatal Death Maternal Death Death
    HPO:Neonatal death Neonatal sepsis Sepsis

    Primary Outcomes

    Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

    Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

    Time: within 6 weeks (42 days)

    Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

    Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

    Time: 4 weeks (28 days) post-delivery

    Secondary Outcomes

    Description: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.

    Measure: Incidence of chorioamnionitis

    Time: prior to delivery

    Description: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.

    Measure: Incidence of endometritis

    Time: within 42 days post-delivery

    Description: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).

    Measure: Incidence of other infections

    Time: within 42 days post-delivery

    Description: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.

    Measure: Incidence of use of subsequent maternal antibiotic therapy

    Time: after randomization to 42 days post-delivery

    Description: Time from drug administration until initial discharge after delivery (time may vary by site).

    Measure: Maternal initial hospital length of stay

    Time: within 42 days post-delivery

    Description: Maternal readmissions within 42 days of delivery

    Measure: Incidence of maternal readmissions

    Time: within 42 days post-delivery

    Description: Maternal admission to special care units

    Measure: Incidence of maternal admission to special care units

    Time: within 42 days post-delivery

    Description: Maternal unscheduled visit for care

    Measure: Incidence of maternal unscheduled visit for care

    Time: within 42 days post-delivery

    Description: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.

    Measure: Incidence of maternal GI symptoms

    Time: within 42 days post-delivery

    Description: Maternal death due to sepsis using the Global Network algorithm for cause of death

    Measure: Incidence of maternal death due to sepsis

    Time: within 42 days post-delivery

    Description: Incidence of other neonatal infections.

    Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection)

    Time: within 42 days post-delivery

    Description: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).

    Measure: Neonatal initial hospital length of stay

    Time: within 28 days of delivery

    Description: Neonatal readmissions within 42 days of delivery

    Measure: Incidence of neonatal readmissions

    Time: within 42 days of delivery

    Description: Neonatal admission to special care units

    Measure: Incidence of neonatal admission to special care units

    Time: within 28 days of delivery

    Description: Neonatal unscheduled visit for care

    Measure: Incidence of neonatal unscheduled visit for care

    Time: within 42 days post-delivery

    Description: Neonatal death due to sepsis using the Global Network algorithm for causes of death

    Measure: Incidence of neonatal death due to sepsis

    Time: within 28 days of delivery

    Description: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.

    Measure: Incidence of pyloric stenosis within 42 days of delivery

    Time: within 42 days of delivery

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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