Neonatal SEPSIS Clinical Trial
Official title:
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
Verified date | May 2023 |
Source | NICHD Global Network for Women's and Children's Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 34000 |
Est. completion date | September 30, 2024 |
Est. primary completion date | October 7, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Pregnant women in labor =28 weeks Gestational Age (GA) (by best estimate) with a pregnancy with one or more live fetuses who plan to deliver vaginally in a facility. - Admitted to health facility with clear plan for spontaneous or induced delivery. - Live fetus must be confirmed via a fetal heart rate by Doptone prior to randomization. - =18 years of age or minors 14-17 years of age in countries where married or pregnant minors (or their authorized representatives) are legally permitted to give consent. - Have provided written informed consent. - Pregnant women in labor =28 weeks GA (by best estimate) with a pregnancy with one or more live fetuses who plan to deliver vaginally in a facility. - Admitted to health facility with clear plan for spontaneous or induced delivery. - Live fetus must be confirmed via presence of a fetal heart rate prior to randomization. - =18 years of age or minors 14-17 years of age in countries where married or pregnant minors (or their authorized representatives) are legally permitted to give consent. - Have provided written informed consent [Note: written informed consent may be obtained during antenatal care, but verbal re-confirmation may be needed (per local regulations) at the time of randomization]. Exclusion Criteria: - Non-emancipated minors (as per local regulations) - Evidence of chorioamnionitis or other infection requiring antibiotic therapy at time of eligibility (however, women given single prophylactic antibiotics with no plans to continue after delivery should not be excluded). - Arrhythmia or known history of cardiomyopathy. - Allergy to azithromycin or other macrolides that is self-reported or documented in the medical record. - Any use of azithromycin, erythromycin, or other macrolide in the 3 days or less prior to randomization. - Plan for cesarean delivery prior to randomization. - Preterm labor undergoing management with no immediate plan to proceed to delivery. - Advanced stage of labor (>6 cm or 10 cm cervical dilation per local standards) and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation. - Are not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum hemorrhage) or mental disorder. - Any other medical conditions that may be considered a contraindication per the judgment of the site investigator. - Previous randomization in the trial. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | ICDDRB | Dhaka | |
Congo, The Democratic Republic of the | Kinshasa School of Public Health | Kinshasa | |
Guatemala | Institute for Nutrition of Central America and Panama (INCAP) | Guatemala City | |
India | Jawaharlal Nehru Medical College | Belagam | |
India | Lata Medical Research Foundation | Nagpur | |
Kenya | Moi University School of Medicine | Eldoret | |
Pakistan | The Aga Khan University | Karachi | |
Zambia | University Teaching Hospital | Lusaka |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Aga Khan University, Bill and Melinda Gates Foundation, Boston University, Columbia University, Indiana University School of Medicine, Institute of Nutrition of Central America and Panama, International Centre for Diarrhoeal Disease Research, Bangladesh, Jawaharlal Nehru Medical College, Kinshasa School of Public Health, Lata Medical Research Foundation, Nagpur, Moi Univeristy, RTI International, Thomas Jefferson University, University of Alabama at Birmingham, University of Colorado, Denver, University of North Carolina, Chapel Hill, University of Virginia, University Teaching Hospital, Lusaka, Zambia |
Bangladesh, Congo, The Democratic Republic of the, Guatemala, India, Kenya, Pakistan, Zambia,
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* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. | Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. | within 6 weeks (42 days) | |
Primary | Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group | Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group | 4 weeks (28 days) post-delivery | |
Secondary | Incidence of chorioamnionitis | 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. | prior to delivery | |
Secondary | Incidence of endometritis | 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. | within 42 days post-delivery | |
Secondary | Incidence of other infections | 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). | within 42 days post-delivery | |
Secondary | Incidence of use of subsequent maternal antibiotic therapy | Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason. | after randomization to 42 days post-delivery | |
Secondary | Maternal initial hospital length of stay | Time from drug administration until initial discharge after delivery (time may vary by site). | within 42 days post-delivery | |
Secondary | Incidence of maternal readmissions | Maternal readmissions within 42 days of delivery | within 42 days post-delivery | |
Secondary | Incidence of maternal admission to special care units | Maternal admission to special care units | within 42 days post-delivery | |
Secondary | Incidence of maternal unscheduled visit for care | Maternal unscheduled visit for care | within 42 days post-delivery | |
Secondary | Incidence of maternal GI symptoms | Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects. | within 42 days post-delivery | |
Secondary | Incidence of maternal death due to sepsis | Maternal death due to sepsis using the Global Network algorithm for cause of death | within 42 days post-delivery | |
Secondary | Incidence of other neonatal infections (e.g. eye infection, skin infection) | Incidence of other neonatal infections. | within 42 days post-delivery | |
Secondary | Neonatal initial hospital length of stay | Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site). | within 28 days of delivery | |
Secondary | Incidence of neonatal readmissions | Neonatal readmissions within 42 days of delivery | within 42 days of delivery | |
Secondary | Incidence of neonatal admission to special care units | Neonatal admission to special care units | within 28 days of delivery | |
Secondary | Incidence of neonatal unscheduled visit for care | Neonatal unscheduled visit for care | within 42 days post-delivery | |
Secondary | Incidence of neonatal death due to sepsis | Neonatal death due to sepsis using the Global Network algorithm for causes of death | within 28 days of delivery | |
Secondary | Incidence of pyloric stenosis within 42 days of delivery | 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. | within 42 days of delivery |
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