Name (Synonyms) | Correlation | |
---|---|---|
drug791 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 1.00 |
drug627 | Placebo oral tablet Wiki | 0.22 |
There is one clinical trial.
COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.
Description: COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
Measure: COVID-19-related hospital admissions Time: Hospital Admission at any point from study enrollment to deliveryDescription: Measurement of reported symptoms using a validated questionnaire on Day 3, 7, 10, and every 2 weeks. The FLU-PRO Questionnaire instructs respondents to rate the severity of 37 influenza symptoms over the past 24 hours, including those related to the nose, throat, eye, chest, head, stomach, fatigue, and body aches/pains. For 32 of 37 items, respondents rated the severity of each symptom on 5-point Likert-type scales from 0 ("Not at all), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), to 4 ("Very much"). For the five remaining items, severity is expressed as frequency of occurrence: vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times), and sneezing, coughing, and coughed up mucus or phlegm on a scale from 0 ("Never") to 4 ("Always"), with higher scores indicating more severe symptoms.
Measure: Symptoms related to COVID-19 infection Time: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to deliveryDescription: Side effects related to hydroxychloqoruine
Measure: Adverse Events Time: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to deliveryDescription: Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: If had cesarean delivery, indication for cesarean section
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Miscarriage or stillbirth (Yes/No)
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Labor induction or augmentation (Yes/No) and indication
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Epidural use (Yes/No)
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Gestational age at delivery (weeks)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Sex (female/male)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Birth weight (kg) Birth weight (kg)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Need for resuscitation (Yes/No)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: NICU admission (Yes/No)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Current disposition of baby (home or hospital)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.