A Phase 3 interventional study of Azithromycin and Placebo in Maternal Death, Maternal Infections Affecting Fetus or Newborn and Neonatal SEPSIS, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 8 sites in 7 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by NICHD Global Network for Women's and Children's Health · Phase 3, Interventional, and Prevention
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.
The A-PLUS Trial is a randomized, placebo-controlled, parallel multicenter clinical trial. The study intervention is a single, prophylactic intrapartum oral dose of 2 g azithromycin, with a comparison with a single intrapartum oral dose of an identical appearing placebo. For the A-PLUS randomized control trial (RCT), a total of 34,000 laboring women from eight research sites in sub-Saharan Africa, South Asia, and Latin America will be randomized with one-to-one ratio to intervention/placebo. In response to the global coronavirus pandemic, research sites will also collect data on COVID-19 signs/symptoms, diagnosis, and treatment in order to estimate the incidence of infection and evaluate the impact of the pandemic on the target population.
Prior to the initiation of the A-PLUS RCT, research sites will conduct an observational pilot study using the RCT's planned infrastructure in order to characterize the current practices at participating research facilities and optimize the identification of suspected infection for the RCT. The information obtained in the pilot study will be used to validate estimates of intrapartum deaths, maternal sepsis, and neonatal sepsis used in the sample size calculations for the RCT. Finally, the pilot study will allow the research sites to inventory and upgrade local capacity to conduct routine cultures during the RCT.
A maximum of 16,000 women, separate from the sample for the main trial, will be enrolled in the pilot, across all eight research sites, with no more than 2000 women enrolled at any individual site. Research sites will be eligible to transition to the RCT when a minimum of 600 participants have been enrolled in the pilot study with evidence of (a) high rates of follow-up; (2) acceptable data quality and completeness; and (3) there are no concerns about identification and reporting of infection.
Given the clinical benefits of intrapartum azithromycin so far reported in two trials and the likelihood that it may become the usual practice if the investigator's large RCT confirms the reported benefits, it is important to monitor antibiotic resistance to determine the safety of azithromycin prophylaxis. Therefore, the RCT will also include an ancillary study (referred to as the antimicrobial resistance (AMR) sub-study) to monitor antimicrobial resistance and maternal and newborn microbiome effects of the single dose of prophylactic azithromycin using the following methodology
For all mothers enrolled in the RCT and their infants:
a. Routine clinical monitoring at baseline and three post-partum time points (3 days, 7 days, and 42 days), with culture and sensitivity testing in cases of suspected bacterial infections;
Among a subset of 1000 randomly selected maternal-infant dyads:
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's enrollment of 58,747 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study intervention is a single 2 g dose of directly observed oral azithromycin.
Drug: Azithromycin
By random allocation, participants will receive four oral placebo pills containing a non-antimicrobial agent directly after randomization.
Drug: Placebo
The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered as four 500 mg pills or tablets directly after randomization. By random allocation, participants will receive 2 g of oral azithromycin.
Identical appearing placebo, administered as a single oral dose directly after randomization.
Maternal Death or Sepsis Within 6 Weeks (42 Days) Post-delivery in Intervention vs. Placebo Group.
Maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.
Time frame: Within 6 weeks (42 days)
Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group
Intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among stillbirths and neonates with 28-day status available born to women randomized. The study includes multiple births so there are more stillbirths and neonates than participants enrolled.
Time frame: Within 4 weeks (28 days) post-delivery
Maternal Sepsis
Maternal sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.
Time frame: Within 42 days post-delivery
Maternal Death Due to Sepsis
Maternal death due to sepsis using the Global Network algorithm for cause of death
Time frame: Within 42 days post-delivery
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.
Time frame: Between date/time of randomization and date/time of delivery (up to 120 hours before delivery)
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.
Time frame: Within 42 days post-delivery
Cesarean Wound Infection
Wound infection (Purulent infection of a 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);
Time frame: Within 42 days post-delivery
Perineal Wound Infection
Wound infection (Purulent infection of a perineal 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);
Time frame: Within 42 days post-delivery
Other Infections
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). Other bacterial infection.
Time frame: Within 42 days post-delivery
Use of Subsequent Maternal Antibiotic Therapy
Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.
Time frame: After randomization to 42 days post-delivery. Randomization occurs between labor onset and delivery (0 to 120 hours before delivery). 42 participants were randomized >120 hours before delivery due to false labor.
Maternal Initial Hospital Length of Stay
Time from drug administration until initial discharge after delivery (time may vary by site).
Time frame: Time from drug administration (which occurs between onset of labor and delivery) and discharge from delivery hospital (0 to 45 days)
Maternal Readmissions
Maternal readmissions after delivery discharge and within 42 days of delivery
Time frame: After delivery discharge and within 42 days post-delivery
Maternal Admission to Special Care Units
Maternal admission to special care units
Time frame: Within 42 days post-delivery (reported during study)
Maternal Unscheduled Visit for Care
Maternal unscheduled visit for care
Time frame: Within 42 days post-delivery (reported during study)
Maternal GI Symptoms
Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.
Time frame: Within 42 days post-delivery (reported during study)
Neonatal Sepsis
Neonatal sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Within 28 days post-delivery
Neonatal Death Due to Sepsis
Neonatal death due to sepsis using the Global Network algorithm for causes of death. This outcome is measured among neonates with 28-day status available born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Within 28 days post-delivery
Other Neonatal Infections
Other neonatal infections (e.g. eye infection, skin infection). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Within 28 days post-delivery
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). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Time from delivery to discharge from delivery hospital (0 to 62 days)
Neonatal Readmissions
Neonatal readmissions to facility after delivery discharge and within 42 days of delivery. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: After delivery discharge and within 42 days of delivery
Neonatal Admission to Special Care Units
Neonatal admission to special care units. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Within 42 days post-delivery (reported during study)
Neonatal Unscheduled Visit for Care
Neonatal unscheduled visit for care. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Within 42 days post-delivery (reported during study)
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. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
Time frame: Within 42 days post-delivery
Randomized, multi-country, double-masked, placebo-controlled trial of azithromycin (single 2g oral dose) initiated during labor, in women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery
| Milestone | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) |
|---|---|---|---|---|
| Started | 14590 | 14687 | 14688 | 14782 |
| Treated | 14589 | 14686 | 14687 | 14781 |
| Included in intention to treat (itt) analysis | 14590 | 14687 | 14688 | 14782 |
| Completed | 14526 | 14658 | 14637 | 14756 |
| Not completed | 64 | 29 | 51 | 26 |
| Withdrew: Withdrawal by subject | 14 | 14 | 14 | 14 |
| Withdrew: Physician decision | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 50 | 15 | 36 | 11 |
Maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.
| Participants | Intervention | Placebo |
|---|---|---|
| Maternal Death or Sepsis Within 6 Weeks (42 Days) Post-delivery in Intervention vs. Placebo Group. | 227 | 344 |
Intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among stillbirths and neonates with 28-day status available born to women randomized. The study includes multiple births so there are more stillbirths and neonates than participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group | 1,540 | 1,526 |
Maternal sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal Sepsis | 219 | 339 |
Maternal death due to sepsis using the Global Network algorithm for cause of death
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal Death Due to Sepsis | 4 | 1 |
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.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Chorioamnionitis | 5 | 8 |
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.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Endometritis | 191 | 294 |
Wound infection (Purulent infection of a 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);
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Cesarean Wound Infection | 77 | 134 |
Wound infection (Purulent infection of a perineal 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);
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Perineal Wound Infection | 149 | 188 |
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). Other bacterial infection.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Other Infections | 149 | 217 |
Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Use of Subsequent Maternal Antibiotic Therapy | 7,937 | 8,180 |
Time from drug administration until initial discharge after delivery (time may vary by site).
| days | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal Initial Hospital Length of Stay | 1.4 ± 1.8 | 1.4 ± 1.9 |
Maternal readmissions after delivery discharge and within 42 days of delivery
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal Readmissions | 124 | 192 |
Maternal admission to special care units
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal Admission to Special Care Units | 116 | 130 |
Maternal unscheduled visit for care
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal Unscheduled Visit for Care | 1,397 | 1,790 |
Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Maternal GI Symptoms | 119 | 110 |
Neonatal sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Neonatal Sepsis | 1,433 | 1,407 |
Neonatal death due to sepsis using the Global Network algorithm for causes of death. This outcome is measured among neonates with 28-day status available born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Neonatal Death Due to Sepsis | 64 | 62 |
Other neonatal infections (e.g. eye infection, skin infection). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Other Neonatal Infections | 763 | 798 |
Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site). This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| days | Intervention Arm | Placebo Arm |
|---|---|---|
| Neonatal Initial Hospital Length of Stay | 1.5 ± 2.4 | 1.5 ± 2.1 |
Neonatal readmissions to facility after delivery discharge and within 42 days of delivery. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Neonatal Readmissions | 553 | 518 |
Neonatal admission to special care units. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Neonatal Admission to Special Care Units | 951 | 927 |
Neonatal unscheduled visit for care. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Neonatal Unscheduled Visit for Care | 3,223 | 3,366 |
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. This outcome is measured among neonates born to women randomized. The study includes multiple births so there are more neonates than maternal participants enrolled.
| Participants | Intervention Arm | Placebo Arm |
|---|---|---|
| Pyloric Stenosis Within 42 Days of Delivery | 8 | 3 |
Collected over Adverse events were monitored continuously throughout the study from time of randomization (between onset of labor and delivery) through 6-weeks post delivery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin Intervention (Mothers) | 12/14,589 (0.1%) | 3/14,589 (0%) | 1,022/14,589 (7%) |
| Azithromycin Intervention (Neonates) | 291/14,686 (2%) | 11/14,686 (0.1%) | 8/14,686 (0.1%) |
| Placebo (Mothers) | 11/14,687 (0.1%) | 3/14,687 (0%) | 1,110/14,687 (7.6%) |
| Placebo (Neonates) | 286/14,781 (1.9%) | 8/14,781 (0.1%) | 3/14,781 (0%) |
| Event | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) |
|---|---|---|---|---|
| Neonatal deathPregnancy, puerperium and perinatal conditions | — | 9/14627 | — | 5/14725 |
| Maternal deathPregnancy, puerperium and perinatal conditions | 3/14589 | — | 1/14687 | — |
| Other maternal serious adverse eventPregnancy, puerperium and perinatal conditions | 0/14589 | — | 2/14687 | — |
| Other neonatal serious adverse eventPregnancy, puerperium and perinatal conditions | — | 1/14627 | — | 2/14725 |
| StillbirthPregnancy, puerperium and perinatal conditions | — | 1/14686 | — | 1/14781 |
| Event | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) |
|---|---|---|---|---|
| Severe vaginal painGeneral disorders | 309/14589 | — | 329/14687 | — |
| Vomited within 15 minutes after study drug administrationGastrointestinal disorders | 311/14589 | — | 279/14687 | — |
| Feeling faint or dizzyCardiac disorders | 241/14589 | — | 309/14687 | — |
| Severe abdominal or uterine painGeneral disorders | 170/14589 | — | 208/14687 | — |
| GI symptoms and other reported side effectsGastrointestinal disorders | 119/14589 | — | 110/14687 | — |
| Foul-smelling vaginal dischargeGeneral disorders | 37/14589 | — | 83/14687 | — |
| Diarrhea/loose stoolsGastrointestinal disorders | 76/14589 | — | 66/14687 | — |
| Nausea/vomitingGastrointestinal disorders | 45/14589 | — | 48/14687 | — |
| Pyloric stenosisGastrointestinal disorders | — | 8/14627 | — | 3/14726 |
Women who were eligible according to the intention-to-treat (ITT) criteria and included in the ITT analysis. Includes baseline data for neonates of randomized maternal participants. Baseline data was not collected for the 115 stillbirths. The number of neonates is larger than the number of maternal participants randomized due to multiple births.
| Age, Continuous(years) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Median | 24 (21 to 28) | — | 24 (21 to 28) | — | 24 (21 to 28) |
| Sex/Gender, Customized(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Female | 14590 | 7123 | 14688 | 7190 | 43591 |
| Male | 0 | 7563 | 0 | 7591 | 15154 |
| Missing Sex | 0 | 1 | 0 | 1 | 2 |
| Race and Ethnicity Not Collected(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Bangladesh | 1406 | 1408 | 1441 | 1446 | 5701 |
| Pakistan | 1825 | 1841 | 1843 | 1862 | 7371 |
| Congo, The Democratic Republic of the | 2181 | 2220 | 2192 | 2231 | 8824 |
| Guatemala | 794 | 794 | 803 | 803 | 3194 |
| Zambia | 1769 | 1784 | 1765 | 1779 | 7097 |
| Kenya | 1829 | 1835 | 1844 | 1846 | 7354 |
| India | 4786 | 4805 | 4800 | 4815 | 19206 |
| Marital status(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Married | 13729 | — | 13834 | — | 27563 |
| Single | 612 | — | 600 | — | 1212 |
| Other | 248 | — | 253 | — | 501 |
| Missing | 1 | — | 1 | — | 2 |
| Maternal education(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| No formal schooling | 3457 | — | 3476 | — | 6933 |
| 1-6 years of schooling | 2002 | — | 2022 | — | 4024 |
| 7-12 years of schooling | 7308 | — | 7325 | — | 14633 |
| >= 13 years of schooling | 1798 | — | 1842 | — | 3640 |
| Missing | 25 | — | 23 | — | 48 |
| Primiparous(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Yes | 6311 | — | 6376 | — | 12687 |
| No | 8277 | — | 8311 | — | 16588 |
| Missing | 2 | — | 1 | — | 3 |
| Multiple birth(Participants) | Azithromycin Intervention (Mothers) | Azithromycin Intervention (Neonates) | Placebo (Mothers) | Placebo (Neonates) | Total |
|---|---|---|---|---|---|
| Yes | 99 | 198 | 95 | 190 | 582 |
| No | 14489 | 14489 | 14592 | 14592 | 58162 |
| Missing | 2 | 0 | 1 | 0 | 3 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified participant data will be made available through the NICHD Data and Specimen Hub (N-DASH) system, a publicly accessible online archive, following publication of the primary paper.
Supporting information: Study protocol, Statistical analysis plan
Time frame: No more than one year after publication of the primary paper. No end date.
Access criteria: Deidentified participant data will be made available through the NICHD Data and Specimen Hub (N-DASH) system, a publicly accessible online archive. Investigators interested in data and access are required to submit their request through N-DASH, per the requirements of the DASH policy. This includes a brief description of the proposed use of the research data, a signed NICHD DASH Data Use Agreement, and IRB approval, exemption, or declaration that the research does not involve human subjects.
Data sharing details ↗ · dash.nichd.nih.gov
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Studies of the drug tested here: Azithromycin
NICHD Global Network for Women's and Children's Health