Trial Outcomes & Findings for BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program (NCT NCT02148952)
NCT ID: NCT02148952
Last Updated: 2024-06-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
157689 participants
Primary outcome timeframe
0-7 days after delivery
Results posted on
2024-06-26
Participant Flow
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.
Unit of analysis: facilities
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Assessing Eligibility and Consent
STARTED
|
83166 60
|
80773 60
|
|
Assessing Eligibility and Consent
COMPLETED
|
80063 60
|
77626 60
|
|
Assessing Eligibility and Consent
NOT COMPLETED
|
3103 0
|
3147 0
|
|
Follow-Up
STARTED
|
80063 60
|
77626 60
|
|
Follow-Up
COMPLETED
|
79798 60
|
77347 60
|
|
Follow-Up
NOT COMPLETED
|
265 0
|
279 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Assessing Eligibility and Consent
Were not eligible for inclusion
|
1241
|
1591
|
|
Assessing Eligibility and Consent
Did not consent or declined follow-up
|
1862
|
1556
|
|
Follow-Up
Lost to Follow-up
|
219
|
231
|
|
Follow-Up
Withdrawal by Subject
|
46
|
48
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Intervention Health Facility Participants
n=60 Facilities
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.
|
Control Health Facility Participants
n=60 Facilities
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.
|
Total
n=120 Facilities
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.6 years
n=81 Participants
|
25.7 years
n=79 Participants
|
25.66 years
n=161107 Participants
|
|
Sex/Gender, Customized
Sex of newborn · Male
|
40558 Participants
n=81447 Participants • 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.
|
39063 Participants
n=78663 Participants • 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.
|
79621 Participants
n=160110 Participants • 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.
|
|
Sex/Gender, Customized
Sex of newborn · Female
|
36976 Participants
n=81447 Participants • 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.
|
36266 Participants
n=78663 Participants • 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.
|
73242 Participants
n=160110 Participants • 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.
|
|
Sex/Gender, Customized
Sex of newborn · Unknown
|
3913 Participants
n=81447 Participants • 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.
|
3334 Participants
n=78663 Participants • 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.
|
7247 Participants
n=160110 Participants • 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.
|
|
Sex: Female, Male
Female
|
81925 Participants
n=81 Participants
|
79182 Participants
n=79 Participants
|
161107 Participants
n=161107 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=81 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=161107 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
81925 participants
n=81 Participants
|
79182 participants
n=79 Participants
|
161107 participants
n=161107 Participants
|
|
Mean Annual Delivery Load
|
1599 deliveries
n=60 Facilities
|
1683 deliveries
n=60 Facilities
|
1641 deliveries
n=120 Facilities
|
|
Functional Classification
Primary health center
|
23 Facilities
n=60 Facilities
|
23 Facilities
n=60 Facilities
|
46 Facilities
n=120 Facilities
|
|
Functional Classification
Community Health Center
|
27 Facilities
n=60 Facilities
|
29 Facilities
n=60 Facilities
|
56 Facilities
n=120 Facilities
|
|
Functional Classification
First referral unit
|
10 Facilities
n=60 Facilities
|
8 Facilities
n=60 Facilities
|
18 Facilities
n=120 Facilities
|
|
Mean distance to district hospital
|
29.5 km
n=60 Facilities
|
30.3 km
n=60 Facilities
|
29.9 km
n=120 Facilities
|
|
Mean skilled birth attendants per facility
|
4.4 number of skilled birth attendants
n=60 Facilities
|
4.4 number of skilled birth attendants
n=60 Facilities
|
4.4 number of skilled birth attendants
n=120 Facilities
|
|
Cluster Size
|
1365 participants per site
n=81 Participants
|
1320 participants per site
n=79 Participants
|
1343 participants per site
n=161107 Participants
|
|
Mean previous pregnancies
|
2.4 previous pregnancies
n=81 Participants
|
2.3 previous pregnancies
n=79 Participants
|
2.36 previous pregnancies
n=161107 Participants
|
|
Minutes between admission and delivery
|
200 minutes
n=81 Participants
|
206 minutes
n=79 Participants
|
203 minutes
n=161107 Participants
|
|
Providers attending delivery
Doctor
|
11115 Participants
n=81925 Participants
|
11599 Participants
n=79 Participants
|
22714 Participants
n=161107 Participants
|
|
Providers attending delivery
Nurse
|
66687 Participants
n=81 Participants
|
64117 Participants
n=79 Participants
|
130804 Participants
n=161107 Participants
|
|
Providers attending delivery
Auxiliary nurse midwife
|
15311 Participants
n=81 Participants
|
14549 Participants
n=79 Participants
|
29860 Participants
n=161107 Participants
|
|
Providers attending delivery
Others
|
2633 Participants
n=81 Participants
|
6560 Participants
n=79 Participants
|
9193 Participants
n=161107 Participants
|
|
No. of offspring
Singleton
|
80402 Participants
n=81 Participants
|
77582 Participants
n=79 Participants
|
157984 Participants
n=161107 Participants
|
|
No. of offspring
Sets of twins
|
515 Participants
n=81 Participants
|
533 Participants
n=79 Participants
|
1048 Participants
n=161107 Participants
|
|
No. of offspring
Sets of triplets
|
5 Participants
n=81 Participants
|
5 Participants
n=79 Participants
|
10 Participants
n=161107 Participants
|
|
No. of offspring
Unknown
|
1,003 Participants
n=81 Participants
|
1,062 Participants
n=79 Participants
|
2065 Participants
n=161107 Participants
|
|
Low birth weight
|
22316 Participants
n=81447 Participants • This refers to the number of newborns whose mothers were enrolled in the trial.
|
22728 Participants
n=78663 Participants • This refers to the number of newborns whose mothers were enrolled in the trial.
|
45044 Participants
n=160110 Participants • This refers to the number of newborns whose mothers were enrolled in the trial.
|
|
Preterm birth
|
15941 Participants
n=81447 Participants • This refers to the number of newborns whose mothers were enrolled in the trial.
|
17703 Participants
n=78663 Participants • This refers to the number of newborns whose mothers were enrolled in the trial.
|
33644 Participants
n=160110 Participants • This refers to the number of newborns whose mothers were enrolled in the trial.
|
PRIMARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about their death, their baby(s) and their morbidity.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79334 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.
|
Control Health Facility Participants
n=76897 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.
|
|---|---|---|
|
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
|
15.1 percentage of women/newborn dyads
|
15.3 percentage of women/newborn dyads
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about their death, and their baby(s)
Percentage of participants with composite rate of perinatal death and maternal death within 7 days
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79789 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.
|
Control Health Facility Participants
n=77337 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.
|
|---|---|---|
|
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
|
4.9 percentage of women and newborns
|
4.7 percentage of women and newborns
|
SECONDARY outcome
Timeframe: 0-7 daysPopulation: 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.
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79790 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.
|
Control Health Facility Participants
n=77338 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.
|
|---|---|---|
|
Count of Participants With Perinatal Death Within 7 Days
|
3839 Participants
|
3606 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced stillbirth.
Newborn outcome; rate of stillbirth
Outcome measures
| Measure |
Intervention Health Facility Participants
n=80061 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.
|
Control Health Facility Participants
n=77454 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.
|
|---|---|---|
|
Count of Participants With Stillbirth
|
1513 Participants
|
1559 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced neonatal death.
Newborn outcome; rate of early neonatal death
Outcome measures
| Measure |
Intervention Health Facility Participants
n=78360 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.
|
Control Health Facility Participants
n=75851 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.
|
|---|---|---|
|
Count of Participants With Early Neonatal Death
|
2409 Participants
|
2119 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about maternal death status.
Maternal outcome; rate of maternal death
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79 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.
|
Control Health Facility Participants
n=77 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.
|
|---|---|---|
|
Count of Participants With Maternal Death
|
78 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: 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".
Maternal outcome; any severe maternal complication within 7 days
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79706 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.
|
Control Health Facility Participants
n=77257 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.
|
|---|---|---|
|
Count of Participants With Severe Maternal Complications
Loss of consciousness for >1 hour
|
505 Participants
|
493 Participants
|
|
Count of Participants With Severe Maternal Complications
High fever with foul-smelling vaginal discharge
|
4073 Participants
|
3871 Participants
|
|
Count of Participants With Severe Maternal Complications
Any maternal severe complication within 7 days
|
9086 Participants
|
9037 Participants
|
|
Count of Participants With Severe Maternal Complications
Seizures
|
67 Participants
|
70 Participants
|
|
Count of Participants With Severe Maternal Complications
Hemorrhage
|
5745 Participants
|
5875 Participants
|
|
Count of Participants With Severe Maternal Complications
Stroke
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)Population: The denominator for this analysis is all women who had non-missing information about whether they had a cesarean section.
Rate of cesarean section
Outcome measures
| Measure |
Intervention Health Facility Participants
n=80922 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.
|
Control Health Facility Participants
n=78120 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.
|
|---|---|---|
|
Count of Participants With Cesarean Section
|
1469 Participants
|
1330 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about their status regarding referral before and after delivery.
Maternal outcome; Rate of maternal inter-facility transfer
Outcome measures
| Measure |
Intervention Health Facility Participants
n=81925 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.
|
Control Health Facility Participants
n=79182 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.
|
|---|---|---|
|
Count of Participants With Maternal Referral, Before or After Delivery
|
5381 Participants
|
4779 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about their newborn(s) referral status.
Newborn outcome; Newborn referral
Outcome measures
| Measure |
Intervention Health Facility Participants
n=81925 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.
|
Control Health Facility Participants
n=79182 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.
|
|---|---|---|
|
Count of Participants With Newborn Referral
|
1455 Participants
|
1186 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about their hysterectomy status within 7 days.
Rate of hysterectomy within 7 days
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79705 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.
|
Control Health Facility Participants
n=77252 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.
|
|---|---|---|
|
Count of Participants With Hysterectomy Within 7 Days
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: The denominator for this analysis is all women who had non-missing information about their status regarding blood transfusion within 7 days.
Rate of blood transfusion within 7 days
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79697 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.
|
Control Health Facility Participants
n=77254 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.
|
|---|---|---|
|
Count of Participants With Blood Transfusion Within 7 Days
|
640 Participants
|
625 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: 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.
Maternal Outcome; Rate of need for follow-up care for Mother
Outcome measures
| Measure |
Intervention Health Facility Participants
n=79655 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.
|
Control Health Facility Participants
n=77220 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.
|
|---|---|---|
|
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
|
2014 Participants
|
2141 Participants
|
SECONDARY outcome
Timeframe: 0-7 days after deliveryPopulation: 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.
Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins)
Outcome measures
| Measure |
Intervention Health Facility Participants
n=77419 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.
|
Control Health Facility Participants
n=75117 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.
|
|---|---|---|
|
Count of Newborns Returning to Facility for a Health Problem Within 7 Days
|
4474 Participants
|
4722 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months post-intervention startPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1259 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.
|
Control Health Facility Participants
n=1304 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.
|
|---|---|---|
|
Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
|
13.1 essential birth practices performed
Interval 12.1 to 14.0
|
7.5 essential birth practices performed
Interval 6.9 to 8.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months post-intervention startPopulation: The denominator for this analysis is all women who were observed at admission, 2 months post-intervention start in the site.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1048 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.
|
Control Health Facility Participants
n=1090 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Birth companion present
|
1048 Participants
|
1087 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Maternal blood pressure taken
|
606 Participants
|
64 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Maternal temperature taken
|
569 Participants
|
4 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Partography started
|
10 Participants
|
1 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Checklist use
|
595 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months post-intervention startPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1039 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.
|
Control Health Facility Participants
n=1130 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Hand hygiene
|
367 Participants
|
7 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
No oxytocin given before delivery
|
704 Participants
|
333 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Clean towel available
|
874 Participants
|
166 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Clean scissors or blade available
|
843 Participants
|
847 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Cord tie available
|
1035 Participants
|
1122 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Mucus extractor available
|
990 Participants
|
1057 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Neonatal bag and mask available
|
991 Participants
|
1109 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Pads available
|
965 Participants
|
502 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Checklist Use
|
255 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months post-intervention startPopulation: The denominator for this analysis is all women who were observed within one minute after delivery, 2 months post-intervention start in the site.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1038 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.
|
Control Health Facility Participants
n=1129 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Oxytocin Administered
|
825 Participants
|
231 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Neonatal bag used
|
47 Participants
|
82 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Birth companion present
|
1037 Participants
|
1125 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months post-intervention startPopulation: The denominator for this analysis is all women who were observed at one hour after delivery, 2 months post-intervention start in the site.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1006 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.
|
Control Health Facility Participants
n=1102 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Newborn temperature taken
|
433 Participants
|
1 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Checklist use
|
747 Participants
|
0 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Newborn weight taken
|
906 Participants
|
884 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Skin-to-skin care initiated at birth
|
794 Participants
|
119 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Skin-to-skin care maintained for 1 hr
|
194 Participants
|
5 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Initiation of breast-feeding
|
700 Participants
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months post-intervention startPopulation: The denominator for this analysis is all women who were observed at any time during delivery, 2 months post-intervention start in the site.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1259 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.
|
Control Health Facility Participants
n=1304 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Maternal temperature taken
|
792 Participants
|
4 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Maternal blood pressure taken
|
854 Participants
|
89 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Mother given magnesium sulfate
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-intervention startPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1127 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.
|
Control Health Facility Participants
n=1198 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.
|
|---|---|---|
|
Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
|
11.1 essential birth practices performed
Interval 10.4 to 11.8
|
7.9 essential birth practices performed
Interval 7.4 to 8.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-intervention startPopulation: The denominator for this analysis is all women who were observed at admission, 12 months post-intervention start in the site.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1007 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.
|
Control Health Facility Participants
n=1009 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Birth companion present
|
1004 Participants
|
1006 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Maternal blood pressure taken
|
219 Participants
|
11 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Maternal temperature taken
|
153 Participants
|
0 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Partography started
|
7 Participants
|
0 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Checklist use
|
175 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-intervention startPopulation: 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.
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
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1018 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.
|
Control Health Facility Participants
n=1042 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Hand hygiene
|
126 Participants
|
6 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
No oxytocin given before delivery
|
527 Participants
|
263 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Clean scissors or blade available
|
1004 Participants
|
1008 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Checklist Use
|
55 Participants
|
1 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Clean towel available
|
721 Participants
|
314 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Cord tie available
|
1009 Participants
|
1039 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Mucus extractor available
|
999 Participants
|
1000 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Neonatal bag and mask available
|
1017 Participants
|
1036 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Pads available
|
768 Participants
|
559 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-intervention startPopulation: The denominator for this analysis is all women who were observed within one minute after delivery, 12 months post-intervention start in the site.
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
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1019 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.
|
Control Health Facility Participants
n=1041 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Birth companion present
|
1016 Participants
|
1035 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Oxytocin Administered
|
549 Participants
|
154 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Neonatal bag used
|
30 Participants
|
49 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-intervention startPopulation: The denominator for this analysis is all women who were observed within one hour after delivery, 12 months post-intervention start in the site.
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
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1000 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.
|
Control Health Facility Participants
n=1014 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Newborn weight taken
|
947 Participants
|
843 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Newborn temperature taken
|
225 Participants
|
2 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Skin-to-skin care initiated at birth
|
685 Participants
|
84 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Skin-to-skin care maintained for 1 hr
|
51 Participants
|
0 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Initiation of breast-feeding
|
369 Participants
|
47 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Checklist use
|
351 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-intervention startPopulation: The denominator for this analysis is all women who were observed at anytime, 12 months post-intervention start in the site.
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.
Outcome measures
| Measure |
Intervention Health Facility Participants
n=1127 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.
|
Control Health Facility Participants
n=1198 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.
|
|---|---|---|
|
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Maternal temperature taken
|
343 Participants
|
0 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Maternal blood pressure taken
|
425 Participants
|
35 Participants
|
|
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Mother given magnesium sulfate
|
1 Participants
|
1 Participants
|
Adverse Events
Intervention Health Facility Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3917 deaths
Control Health Facility Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3677 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place