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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Population Services International | OTHER |
| Jawaharlal Nehru Medical College | OTHER |
| Community Empowerment Lab |
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The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in north India.
The WHO Safe Childbirth Checklist Program is a quality improvement program designed to support health workers to deliver evidence-based practices to women and newborns around the time of institutional childbirths. At the program's core is the Safe Childbirth Checklist, a 31-item list of essential practices that target the major causes of maternal and newborn mortality in low-resource settings globally. The program was developed over 3 years by a partnership of WHO and HSPH, working with a large international network of experts and stakeholders in maternal, fetal, and newborn health. Pilot testing of the program at a public-sector birth center in south India demonstrated dramatic improvements in health worker adherence to essential childbirth-related clinical care standards. The current study is a matched-pair, cluster randomized trial to measure the efficacy of the program in reducing severe maternal and newborn harm. This trial will be conducted at approximately 120 health facilities in Uttar Pradesh, India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Health Facility | Experimental | WHO Safe Childbirth Checklist Program |
|
| Control Health Facility | No Intervention | Matched control facilities providing comparison for intervention facilities |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHO Safe Childbirth Checklist Program | Behavioral | The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days | The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke. | 0-7 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days | Percentage of participants with composite rate of perinatal death and maternal death within 7 days | 0-7 days after delivery |
| Count of Participants With Perinatal Death Within 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Gawande, MD, MPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Vishwajeet Kumar, MBBS, MPH | Community Empowerment Lab | Principal Investigator |
| Bhala Kodkany, MBBS | Jawarhlal Nehru Medical College | Principal Investigator |
| Katherine Semrau, PhD | Harvard Medical School/ Ariadne Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PSI | Lucknow | Uttar Pradesh | 226 010 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35131826 | Derived | Lofgren KT, Bobanski L, Tuller DE, Singh VP, Marx Delaney M, Jurczak A, Ragavan M, Kalita T, Karlage A, Resch SC, Semrau KEA. Estimating maternity ward birth attendant time use in India: a microcosting study. BMJ Open. 2022 Feb 7;12(2):e054164. doi: 10.1136/bmjopen-2021-054164. | |
| 32928798 | Derived | Semrau KE, Miller KA, Lipsitz S, Fisher-Bowman J, Karlage A, Neville BA, Krasne M, Gass J, Jurczak A, Pratap Singh V, Singh S, Marx Delaney M, Hirschhorn LR, Kodkany B, Kumar V, Gawande AA. Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India. BMJ Glob Health. 2020 Sep;5(9):e002268. doi: 10.1136/bmjgh-2019-002268. |
| Label | URL |
|---|---|
| WHO Safe Childbirth Checklist | View source |
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320 facilities were assessed for eligibility. 200 were excluded (37 did not meet inclusion criteria, 163 did not have a matching facility identified).
A total of 163,939 women were screened for eligibility; of those, 161,107 women were eligible for participation, and 157,689 women consented and were enrolled into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Health Facility Participants | Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection. |
| FG001 | Control Health Facility Participants | Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Assessing Eligibility and Consent |
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| Follow-Up |
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The baseline analysis population may refer to number of women, number of newborns, or number of facilities, depending on the measure. We obtained facility consent to collect baseline information for a total of 161,107 women who were eligible for inclusion. A total of 157,687 women consented to participate in follow-up.
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Health Facility Participants | Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Please note the measure of dispersion is a 95% confidence interval (not full range). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days | The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke. | The denominator for this analysis is all women who had non-missing information about their death, their baby(s) and their morbidity. | Posted | Number | percentage of women/newborn dyads | 0-7 days after delivery |
|
Adverse events were monitored for occurrence and reporting throughout the duration of the study period (2 years).
Maternal & neonatal mortality were measured as outcomes, not as adverse events. No adverse events such as death or morbidity were linked to direct effect of the trial. Our adverse events included loss of a consent form or a breach of PHI.
While our outcomes denominators reflect either the woman/newborn dyad or women only, this denominator includes all individual mothers plus all individual newborns enrolled in the trial, in order to obtain an all cause mortality count.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Health Facility Participants | Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Semrau | Ariadne Labs | 617-384-6555 | betterbirth@ariadnelabs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2017 | Oct 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063130 | Maternal Death |
| D050497 | Stillbirth |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Brigham and Women's Hospital | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
| MacArthur Foundation | OTHER |
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|
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death) |
| 0-7 days |
| Count of Participants With Stillbirth | Newborn outcome; rate of stillbirth | 0-7 days after delivery |
| Count of Participants With Early Neonatal Death | Newborn outcome; rate of early neonatal death | 0-7 days after delivery |
| Count of Participants With Maternal Death | Maternal outcome; rate of maternal death | 0-7 days after delivery |
| Count of Participants With Severe Maternal Complications | Maternal outcome; any severe maternal complication within 7 days | 0-7 days after delivery |
| Count of Participants With Cesarean Section | Rate of cesarean section | Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary) |
| Count of Participants With Maternal Referral, Before or After Delivery | Maternal outcome; Rate of maternal inter-facility transfer | 0-7 days after delivery |
| Count of Participants With Newborn Referral | Newborn outcome; Newborn referral | 0-7 days after delivery |
| Count of Participants With Hysterectomy Within 7 Days | Rate of hysterectomy within 7 days | 0-7 days after delivery |
| Count of Participants With Blood Transfusion Within 7 Days | Rate of blood transfusion within 7 days | 0-7 days after delivery |
| Count of Mothers Returning to Facility for a Health Problem Within 7 Days | Maternal Outcome; Rate of need for follow-up care for Mother | 0-7 days after delivery |
| Count of Newborns Returning to Facility for a Health Problem Within 7 Days | Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins) | 0-7 days after delivery |
| 2 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start. | 2 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start. | 2 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start. | 2 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start. | 2 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start. | 2 months post-intervention start |
| Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start. | 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start. | 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start | 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start | 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start | 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start. | 12 months post-intervention start |
| 32885188 | Derived | Barnhart DA, Semrau KEA, Zigler CM, Molina RL, Delaney MM, Hirschhorn LR, Spiegelman D. Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial. Implement Sci Commun. 2020 Feb 25;1:29. doi: 10.1186/s43058-020-00014-8. eCollection 2020. |
| 31900167 | Derived | Molina RL, Neal BJ, Bobanski L, Singh VP, Neville BA, Delaney MM, Lipsitz S, Karlage A, Shetye M, Semrau KEA. Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial. Implement Sci. 2020 Jan 3;15(1):1. doi: 10.1186/s13012-019-0962-7. |
| 29862506 | Derived | Hirschhorn LR, Krasne M, Maisonneuve J, Kara N, Kalita T, Henrich N, Rana D, Maji P, Delaney MM, Firestone R, Sharma N, Kumar V, Gawande AA, Semrau KEA. Integration of the Opportunity-Ability-Motivation behavior change framework into a coaching-based WHO Safe Childbirth Checklist program in India. Int J Gynaecol Obstet. 2018 Sep;142(3):321-328. doi: 10.1002/ijgo.12542. Epub 2018 Jun 20. |
| 29718354 | Derived | Maisonneuve JJ, Semrau KEA, Maji P, Pratap Singh V, Miller KA, Solsky I, Dixit N, Sharma J, Lagoo J, Panariello N, Neal BJ, Kalita T, Kara N, Kumar V, Hirschhorn LR. Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India. Int J Qual Health Care. 2018 Dec 1;30(10):769-777. doi: 10.1093/intqhc/mzy086. |
| 29236628 | Derived | Semrau KEA, Hirschhorn LR, Marx Delaney M, Singh VP, Saurastri R, Sharma N, Tuller DE, Firestone R, Lipsitz S, Dhingra-Kumar N, Kodkany BS, Kumar V, Gawande AA; BetterBirth Trial Group. Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India. N Engl J Med. 2017 Dec 14;377(24):2313-2324. doi: 10.1056/NEJMoa1701075. |
| 28882167 | Derived | Gass JD Jr, Misra A, Yadav MNS, Sana F, Singh C, Mankar A, Neal BJ, Fisher-Bowman J, Maisonneuve J, Delaney MM, Kumar K, Singh VP, Sharma N, Gawande A, Semrau K, Hirschhorn LR. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India. Trials. 2017 Sep 7;18(1):418. doi: 10.1186/s13063-017-2159-1. |
| 27923401 | Derived | Semrau KE, Hirschhorn LR, Kodkany B, Spector JM, Tuller DE, King G, Lipsitz S, Sharma N, Singh VP, Kumar B, Dhingra-Kumar N, Firestone R, Kumar V, Gawande AA. Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial. Trials. 2016 Dec 7;17(1):576. doi: 10.1186/s13063-016-1673-x. |
| 26271331 | Derived | Hirschhorn LR, Semrau K, Kodkany B, Churchill R, Kapoor A, Spector J, Ringer S, Firestone R, Kumar V, Gawande A. Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India. Implement Sci. 2015 Aug 14;10:117. doi: 10.1186/s13012-015-0309-y. |
| Ariadne Labs | View source |
| NOT COMPLETED |
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| BG001 | Control Health Facility Participants | Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities. |
| BG002 | Total | Total of all reporting groups |
| Facilities |
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| Mean |
| Full Range |
| years |
| Participants |
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| Sex/Gender, Customized | Sex of the newborn. | This refers to the number of newborns whose mothers were enrolled in the trial. In "unknown" cases, the mother was referred to another facility before the data were captured. | Count of Participants | Participants | Participants |
|
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| Sex: Female, Male | Pregnant women were enrolled in the trial; thus, all are female. | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Mean Annual Delivery Load | This characteristic was used for facility matching before randomization. Please note the measure of dispersion is a 95% confidence interval (not full range). | Mean | Full Range | deliveries | Facilities |
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| Functional Classification | This characteristic was used for facility matching before randomization. | Count of Units | Facilities | Facilities |
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| Mean distance to district hospital | This characteristic was used for facility matching before randomization. Please note the measure of dispersion is a 95% confidence interval (not full range). | Mean | Full Range | km | Facilities |
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| Mean skilled birth attendants per facility | This characteristic was used for facility matching before randomization. Please note the measure of dispersion is a 95% confidence interval (not full range). | Mean | Full Range | number of skilled birth attendants | Facilities |
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| Cluster Size | Cluster size is the total number of pregnant women enrolled per site (cluster). Please note the measure of dispersion is a 95% confidence interval (not full range). | Mean | Full Range | participants per site | Participants |
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| Mean previous pregnancies | Please note the measure of dispersion is a 95% confidence interval (not full range). | Mean | Full Range | previous pregnancies | Participants |
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| Minutes between admission and delivery | Please note the measure of dispersion is a 95% confidence interval (not full range). | Mean | Full Range | minutes | Participants |
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| Providers attending delivery | Count of Participants | Participants | Participants |
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| No. of offspring | Count of Participants | Participants | Participants |
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| Low birth weight | Occurrence of low birth weight. Low birth weight was defined as 2500 g or less. | This refers to the number of newborns whose mothers were enrolled in the trial. | Count of Participants | Participants | Participants |
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| Preterm birth | Occurrence of preterm birth. Preterm birth was defined as fewer than 37 weeks of gestation. | This refers to the number of newborns whose mothers were enrolled in the trial. | Count of Participants | Participants | Participants |
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| OG001 | Control Health Facility Participants | Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities. |
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| Secondary | Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days | Percentage of participants with composite rate of perinatal death and maternal death within 7 days | The denominator for this analysis is all women who had non-missing information about their death, and their baby(s) | Posted | Number | percentage of women and newborns | 0-7 days after delivery |
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| Secondary | Count of Participants With Perinatal Death Within 7 Days | Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death) | There is a discrepancy between the denominator of each primary and secondary outcome because there were a different number of newborns than mothers in the trial. Additionally, we do not have data on every participant for every question. As such, the denominator is specific for each outcome. | Posted | Count of Participants | Participants | 0-7 days |
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| Secondary | Count of Participants With Stillbirth | Newborn outcome; rate of stillbirth | The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced stillbirth. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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|
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| Secondary | Count of Participants With Early Neonatal Death | Newborn outcome; rate of early neonatal death | The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced neonatal death. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Participants With Maternal Death | Maternal outcome; rate of maternal death | The denominator for this analysis is all women who had non-missing information about maternal death status. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Participants With Severe Maternal Complications | Maternal outcome; any severe maternal complication within 7 days | The denominator for this analysis is all women who had non-missing information about each morbidity. Not every respondent answered each question, so each row has a different denominator. Only women who answered all specific morbidity questions were incorporated into the participant count for "any maternal severe complication within 7 days". | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Participants With Cesarean Section | Rate of cesarean section | The denominator for this analysis is all women who had non-missing information about whether they had a cesarean section. | Posted | Count of Participants | Participants | Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary) |
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| Secondary | Count of Participants With Maternal Referral, Before or After Delivery | Maternal outcome; Rate of maternal inter-facility transfer | The denominator for this analysis is all women who had non-missing information about their status regarding referral before and after delivery. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Participants With Newborn Referral | Newborn outcome; Newborn referral | The denominator for this analysis is all women who had non-missing information about their newborn(s) referral status. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Participants With Hysterectomy Within 7 Days | Rate of hysterectomy within 7 days | The denominator for this analysis is all women who had non-missing information about their hysterectomy status within 7 days. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Participants With Blood Transfusion Within 7 Days | Rate of blood transfusion within 7 days | The denominator for this analysis is all women who had non-missing information about their status regarding blood transfusion within 7 days. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Mothers Returning to Facility for a Health Problem Within 7 Days | Maternal Outcome; Rate of need for follow-up care for Mother | The denominator for this analysis is all women who had non-missing information about returning to a health facility for a health problem within 7 days. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Secondary | Count of Newborns Returning to Facility for a Health Problem Within 7 Days | Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins) | The denominator for this analysis is all women who had non-missing information about status of at least one baby returning to the facility for a health problem within 7 days. | Posted | Count of Participants | Participants | 0-7 days after delivery |
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| Other Pre-specified | Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start. | The denominator for this analysis is all women who were observed for at least one pause point 2 months post-intervention start in the site. | Posted | Mean | 95% Confidence Interval | essential birth practices performed | 2 months post-intervention start |
|
|
|
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| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start. | The denominator for this analysis is all women who were observed at admission, 2 months post-intervention start in the site. | Posted | Count of Participants | Participants | 2 months post-intervention start |
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|
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| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start. | The denominator for this analysis is all women who were observed at the time of labor just before pushing, 2 months post-intervention start in the site. | Posted | Count of Participants | Participants | 2 months post-intervention start |
|
|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start. | The denominator for this analysis is all women who were observed within one minute after delivery, 2 months post-intervention start in the site. | Posted | Count of Participants | Participants | 2 months post-intervention start |
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|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start. | The denominator for this analysis is all women who were observed at one hour after delivery, 2 months post-intervention start in the site. | Posted | Count of Participants | Participants | 2 months post-intervention start |
|
|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start. | The denominator for this analysis is all women who were observed at any time during delivery, 2 months post-intervention start in the site. | Posted | Count of Participants | Participants | 2 months post-intervention start |
|
|
|
|
| Other Pre-specified | Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start. | The denominator for this analysis is all women who were observed for at least one pause point 12 months post-intervention start in the site. | Posted | Mean | 95% Confidence Interval | essential birth practices performed | 12 months post-intervention start |
|
|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start. | The denominator for this analysis is all women who were observed at admission, 12 months post-intervention start in the site. | Posted | Count of Participants | Participants | 12 months post-intervention start |
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|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start | The denominator for this analysis is all women who were observed at the time just before pushing, 12 months post-intervention start in the site. | Posted | Count of Participants | Participants | 12 months post-intervention start |
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|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start | The denominator for this analysis is all women who were observed within one minute after delivery, 12 months post-intervention start in the site. | Posted | Count of Participants | Participants | 12 months post-intervention start |
|
|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start | The denominator for this analysis is all women who were observed within one hour after delivery, 12 months post-intervention start in the site. | Posted | Count of Participants | Participants | 12 months post-intervention start |
|
|
|
|
| Other Pre-specified | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start. | The denominator for this analysis is all women who were observed at anytime, 12 months post-intervention start in the site. | Posted | Count of Participants | Participants | 12 months post-intervention start |
|
|
|
|
| 3,917 |
| 159,587 |
| 0 |
| 159,587 |
| 0 |
| 159,587 |
| EG001 | Control Health Facility Participants | Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities. | 3,677 | 154,684 | 0 | 154,684 | 0 | 154,684 |
Not provided
Not provided
| D005313 |
| Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Unknown |
|
| First referral unit |
|
|
|
|
| Sets of triplets |
|
| Unknown |
|
| Seizures |
|
|
| Loss of consciousness for >1 hour |
|
|
| High fever with foul-smelling vaginal discharge |
|
|
| Hemorrhage |
|
|
| Stroke |
|
|
Rate of seizures |
| Chi-squared, Corrected |
| 0.76 |
| Risk Ratio (RR) |
| 0.89 |
| 2-Sided |
| 95 |
| 0.57 |
| 1.52 |
Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes. |
| Superiority |
| Rate of loss of consciousness for > 1 hr | Chi-squared, Corrected | 0.97 | Risk Ratio (RR) | 0.98 | 2-Sided | 95 | 0.70 | 1.41 | Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes. | Superiority |
| Rate of high fever with foul-smelling vaginal discharge | Chi-squared, Corrected | 0.90 | Risk Ratio (RR) | 1.02 | 2-Sided | 95 | 0.76 | 1.38 | Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes. | Superiority |
| Rate of hemorrhage | Chi-squared, Corrected | 0.61 | Risk Ratio (RR) | 0.95 | 2-Sided | 95 | 0.77 | 1.17 | Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes. | Superiority |
| Rate of stroke | Chi-squared, Corrected | 0.41 | Risk Ratio (RR) | 0.50 | 2-Sided | 95 | 0.34 | 1.58 | Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes. | Superiority |
| Maternal temperature taken |
|
| Partography started |
|
| Checklist use |
|
| Chi-squared, Corrected |
| <0.001 |
| Risk Ratio (RR) |
| 9.8 |
| 2-Sided |
| 95 |
| 3.4 |
| 28.3 |
| Superiority |
| Maternal temperature taken | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 132 | 2-Sided | 95 | 26.9 | 645 | Superiority |
| Partography started | Chi-squared, Corrected | 0.01 | Risk Ratio (RR) | 7.3 | 2-Sided | 95 | 1.5 | 35.6 | Superiority |
| Checklist use | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 413 | 2-Sided | 95 | 65.8 | 2589 | Superiority |
| Clean towel available |
|
| Clean scissors or blade available |
|
| Cord tie available |
|
| Mucus extractor available |
|
| Neonatal bag and mask available |
|
| Pads available |
|
| Checklist Use |
|
| 0.007 |
| Risk Ratio (RR) |
| 2.3 |
| 2-Sided |
| 95 |
| 1.3 |
| 4.2 |
| Superiority |
| Clean towel available | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 5.7 | 2-Sided | 95 | 2.7 | 12.1 | Superiority |
| Clean scissors or blade available | Chi-squared, Corrected | 0.72 | Risk Ratio (RR) | 1.1 | 2-Sided | 95 | 0.7 | 1.7 | Superiority |
| Cord tie available | Chi-squared, Corrected | 0.48 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.0 | Superiority |
| Mucus extractor available | Chi-squared, Corrected | 0.73 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 0.9 | 1.1 | Superiority |
| Neonatal bag and mask available | Chi-squared, Corrected | 0.56 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 0.9 | 1.1 | Superiority |
| Pads available | Chi-squared, Corrected | 0.005 | Risk Ratio (RR) | 2.1 | 2-Sided | 95 | 1.3 | 3.5 | Superiority |
| Checklist use | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 185 | 2-Sided | 95 | 19.7 | 1738 | Superiority |
| Birth companion present |
|
| 0.25 |
| Risk Ratio (RR) |
| 0.6 |
| 2-Sided |
| 95 |
| 0.3 |
| 1.4 |
| Superiority |
| Birth attendant present | Chi-squared, Corrected | 0.25 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.0 | Superiority |
| Skin-to-skin care initiated at birth |
|
| Skin-to-skin care maintained for 1 hr |
|
| Initiation of breast-feeding |
|
| Checklist use |
|
| <0.001 |
| Risk Ratio (RR) |
| 317 |
| 2-Sided |
| 95 |
| 50.4 |
| 1989 |
| Superiority |
| Skin-to-skin care initiated at birth | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 7.3 | 2-Sided | 95 | 2.4 | 22.0 | Superiority |
| Skin-to-skin care maintained for 1 hr | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 38.7 | 2-Sided | 95 | 7.7 | 194 | Superiority |
| Initiation of breast-feeding | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 19.4 | 2-Sided | 95 | 11.4 | 33.2 | Superiority |
| Checklist use | Chi-squared, Corrected | <0.001 | Other | 0 | 2-Sided | The relative risk could not be calculated owing to 100% or 0% values in one group. | Superiority |
| Mother given magnesium sulfate |
|
| <0.001 |
| Risk Ratio (RR) |
| 9.9 |
| 2-Sided |
| 95 |
| 3.8 |
| 25.8 |
| Superiority |
| Mother given magnesium sulfate | Chi-squared, Corrected | 0.30 | Risk Ratio (RR) | 0.4 | 2-Sided | 95 | 0.1 | 2.1 | Superiority |
| Maternal temperature taken |
|
| Partography started |
|
| Checklist use |
|
| <0.001 |
| Risk Ratio (RR) |
| 19.1 |
| 2-Sided |
| 95 |
| 7.9 |
| 46.5 |
| Superiority |
| Maternal temperature taken | Chi-squared, Corrected | <0.001 | Other | 0 | 2-Sided | The relative risk could not be calculated due to 100% or 0% values in one group. | Superiority |
| Partography started | Chi-squared, Corrected | <0.001 | Other | 0 | 2-Sided | The relative risk could not be calculated owing to 100% or 0% values in one group. | Superiority |
| Checklist use | Chi-squared, Corrected | <0.001 | Other | 0 | 2-Sided | The relative risk could not be calculated owing to 100% or 0% values in one group. | Superiority |
| Clean towel available |
|
| Clean scissors or blade available |
|
| Cord tie available |
|
| Mucus extractor available |
|
| Neonatal bag and mask available |
|
| Pads available |
|
| Checklist Use |
|
| 0.04 |
| Risk Ratio (RR) |
| 2.1 |
| 2-Sided |
| 95 |
| 1.0 |
| 4.1 |
| Superiority |
| Clean towel available | Chi-squared, Corrected | 0.006 | Risk Ratio (RR) | 2.4 | 2-Sided | 95 | 1.3 | 4.3 | Superiority |
| Clean scissors or blade available | Chi-squared, Corrected | 0.34 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.1 | Superiority |
| Cord tie available | Chi-squared, Corrected | 0.25 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.0 | Superiority |
| Mucus extractor available | Chi-squared, Corrected | 0.50 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.1 | Superiority |
| Neonatal bag and mask available | Chi-squared, Corrected | 0.32 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.0 | Superiority |
| Pads available | Chi-squared, Corrected | 0.11 | Risk Ratio (RR) | 1.4 | 2-Sided | 95 | 0.9 | 2.1 | Superiority |
| Checklist available | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 37.9 | 2-Sided | 95 | 7.3 | 196 | Superiority |
| Birth companion present |
|
| 0.19 |
| Risk Ratio (RR) |
| 0.6 |
| 2-Sided |
| 95 |
| 0.3 |
| 1.3 |
| Superiority |
| Birth companion present | Chi-squared, Corrected | 0.50 | Risk Ratio (RR) | 1.0 | 2-Sided | 95 | 1.0 | 1.0 | Superiority |
| Skin-to-skin care initiated at birth |
|
| Skin-to-skin care maintained for 1 hr |
|
| Initiation of breast-feeding |
|
| Checklist use |
|
| <0.001 |
| Risk Ratio (RR) |
| 91.5 |
| 2-Sided |
| 95 |
| 11.0 |
| 758 |
| Superiority |
| Skin-to-skin care initiated at birth | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 8.2 | 2-Sided | 95 | 2.5 | 27.5 | Superiority |
| Skin-to-skin care maintained for 1 hr | Chi-squared, Corrected | 0.01 | Other | 0 | 2-Sided | The relative risk could not be calculated owing to 100% or 0% values in one group. | Superiority |
| Initiation of breast-feeding | Chi-squared, Corrected | <0.001 | Risk Ratio (RR) | 7.9 | 2-Sided | 95 | 3.7 | 16.7 | Superiority |
| Checklist use | Chi-squared, Corrected | <0.001 | Other | 0 | 2-Sided | The relative risk could not be calculated owing to 100% or 0% values in one group. | Superiority |
| Mother given magnesium sulfate |
|
| Chi-squared, Corrected |
| <0.001 |
| Risk Ratio (RR) |
| 12.7 |
| 2-Sided |
| 95 |
| 4.7 |
| 34.3 |
| Superiority |
| Mother given magnesium sulfate | Chi-squared, Corrected | 0.95 | Risk Ratio (RR) | 1.1 | 2-Sided | 95 | 0.2 | 6.6 | Superiority |