Trial Outcomes & Findings for Zambia Chlorhexidine Application Trial (NCT NCT01241318)
NCT ID: NCT01241318
Last Updated: 2020-08-31
Results Overview
All-cause neonatal mortality based on vital status at 28 days post-partum
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
77535 participants
Primary outcome timeframe
28 days post-partum
Results posted on
2020-08-31
Participant Flow
In the 90 clusters (i.e. government-run health facilities), pregnant women who met eligibility criteria attending antenatal care were offered enrollment. Recruitment started February 15, 2011 and ended January 30, 2013.
Mothers were enrolled in the study while pregnant and infants were enrolled after delivery; thus the total protocol enrollment is women + infants. Study reporting is completed at the woman level and thus the total enrolled is listed at the woman level in the outcomes tables.
Participant milestones
| Measure |
Chlorhexidine Cord Care
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
Dry Cord Care
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
|---|---|---|
|
Overall Study
STARTED
|
19629
|
20050
|
|
Overall Study
Liveborn Infant
|
18510
|
19346
|
|
Overall Study
COMPLETED
|
18450
|
19308
|
|
Overall Study
NOT COMPLETED
|
1179
|
742
|
Reasons for withdrawal
| Measure |
Chlorhexidine Cord Care
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
Dry Cord Care
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
|---|---|---|
|
Overall Study
Woman: false pregnancies
|
27
|
15
|
|
Overall Study
Woman: miscarriage/abortion
|
46
|
38
|
|
Overall Study
Withdrawal by Subject
|
175
|
46
|
|
Overall Study
Lost to Follow-up
|
740
|
455
|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Withdrew/Lost to Follow after delivery
|
60
|
38
|
|
Overall Study
Woman: Stillborn infant
|
129
|
146
|
Baseline Characteristics
Zambia Chlorhexidine Application Trial
Baseline characteristics by cohort
| Measure |
Chlorhexidine Cord Care
n=19629 Participants
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
Dry Cord Care
n=20050 Participants
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Total
n=39679 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20 years
|
4671 participants
n=5 Participants
|
4580 participants
n=7 Participants
|
9251 participants
n=5 Participants
|
|
Age, Customized
20-35 years
|
12772 participants
n=5 Participants
|
13122 participants
n=7 Participants
|
25894 participants
n=5 Participants
|
|
Age, Customized
>35 years
|
2012 participants
n=5 Participants
|
2194 participants
n=7 Participants
|
4206 participants
n=5 Participants
|
|
Age, Customized
Missing (not recorded)
|
174 participants
n=5 Participants
|
154 participants
n=7 Participants
|
328 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19629 Participants
n=5 Participants
|
20050 Participants
n=7 Participants
|
39679 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Tonga
|
17003 participants
n=5 Participants
|
17650 participants
n=7 Participants
|
34653 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ila
|
105 participants
n=5 Participants
|
121 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Lozi
|
786 participants
n=5 Participants
|
795 participants
n=7 Participants
|
1581 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Nyanja
|
525 participants
n=5 Participants
|
432 participants
n=7 Participants
|
957 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bemba
|
413 participants
n=5 Participants
|
433 participants
n=7 Participants
|
846 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
629 participants
n=5 Participants
|
481 participants
n=7 Participants
|
1110 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing (not recorded)
|
168 participants
n=5 Participants
|
138 participants
n=7 Participants
|
306 participants
n=5 Participants
|
|
Region of Enrollment
Zambia
|
19629 participants
n=5 Participants
|
20050 participants
n=7 Participants
|
39679 participants
n=5 Participants
|
|
Maternal Education
No eduction
|
1936 participants
n=5 Participants
|
1958 participants
n=7 Participants
|
3894 participants
n=5 Participants
|
|
Maternal Education
Lower Primary
|
2293 participants
n=5 Participants
|
2563 participants
n=7 Participants
|
4856 participants
n=5 Participants
|
|
Maternal Education
Upper Primary
|
7731 participants
n=5 Participants
|
7874 participants
n=7 Participants
|
15605 participants
n=5 Participants
|
|
Maternal Education
Junior Secondary
|
5422 participants
n=5 Participants
|
5499 participants
n=7 Participants
|
10921 participants
n=5 Participants
|
|
Maternal Education
Upper Secondary
|
1895 participants
n=5 Participants
|
1840 participants
n=7 Participants
|
3735 participants
n=5 Participants
|
|
Maternal Education
>Upper Secondary
|
180 participants
n=5 Participants
|
160 participants
n=7 Participants
|
340 participants
n=5 Participants
|
|
Maternal Education
Do not know
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Maternal Education
Missing (not recorded)
|
169 participants
n=5 Participants
|
146 participants
n=7 Participants
|
315 participants
n=5 Participants
|
|
Marital Status
Single
|
3021 participants
n=5 Participants
|
3133 participants
n=7 Participants
|
6154 participants
n=5 Participants
|
|
Marital Status
Married
|
16107 participants
n=5 Participants
|
16499 participants
n=7 Participants
|
32606 participants
n=5 Participants
|
|
Marital Status
Separated, divorced or widowed
|
224 participants
n=5 Participants
|
187 participants
n=7 Participants
|
411 participants
n=5 Participants
|
|
Marital Status
Cohabiting
|
109 participants
n=5 Participants
|
89 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Marital Status
Missing (not recorded)
|
168 participants
n=5 Participants
|
142 participants
n=7 Participants
|
310 participants
n=5 Participants
|
|
Maternal literacy
Not at all
|
5037 participants
n=5 Participants
|
5491 participants
n=7 Participants
|
10528 participants
n=5 Participants
|
|
Maternal literacy
A bit
|
8835 participants
n=5 Participants
|
9516 participants
n=7 Participants
|
18351 participants
n=5 Participants
|
|
Maternal literacy
Very well
|
5492 participants
n=5 Participants
|
4835 participants
n=7 Participants
|
10327 participants
n=5 Participants
|
|
Maternal literacy
No response from mother
|
77 participants
n=5 Participants
|
61 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Maternal literacy
Missing (not recorded)
|
188 participants
n=5 Participants
|
147 participants
n=7 Participants
|
335 participants
n=5 Participants
|
|
Household water source
Household tap
|
1861 participants
n=5 Participants
|
1715 participants
n=7 Participants
|
3576 participants
n=5 Participants
|
|
Household water source
Community tap
|
1919 participants
n=5 Participants
|
1761 participants
n=7 Participants
|
3680 participants
n=5 Participants
|
|
Household water source
Other water source on own property
|
2295 participants
n=5 Participants
|
2403 participants
n=7 Participants
|
4698 participants
n=5 Participants
|
|
Household water source
Community well or river
|
13241 participants
n=5 Participants
|
13768 participants
n=7 Participants
|
27009 participants
n=5 Participants
|
|
Household water source
No answer from Mother
|
56 participants
n=5 Participants
|
62 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Household water source
Other
|
67 participants
n=5 Participants
|
166 participants
n=7 Participants
|
233 participants
n=5 Participants
|
|
Household water source
Missing (Not recorded)
|
190 participants
n=5 Participants
|
175 participants
n=7 Participants
|
365 participants
n=5 Participants
|
|
Parity
|
2.4 pregnancies
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.5 pregnancies
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.5 pregnancies
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Gravida
|
3.5 deliveries
STANDARD_DEVIATION 2.3 • n=5 Participants
|
3.6 deliveries
STANDARD_DEVIATION 2.4 • n=7 Participants
|
3.6 deliveries
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Gestational Age at enrollment
|
28.0 weeks
STANDARD_DEVIATION 7.2 • n=5 Participants
|
28.4 weeks
STANDARD_DEVIATION 7.2 • n=7 Participants
|
28.3 weeks
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Slept under mosquito bednet the previous night
Yes
|
11092 participants
n=5 Participants
|
11783 participants
n=7 Participants
|
22875 participants
n=5 Participants
|
|
Slept under mosquito bednet the previous night
No
|
8310 participants
n=5 Participants
|
8075 participants
n=7 Participants
|
16385 participants
n=5 Participants
|
|
Slept under mosquito bednet the previous night
Missing (not recorded)
|
227 participants
n=5 Participants
|
192 participants
n=7 Participants
|
419 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post-partumAll-cause neonatal mortality based on vital status at 28 days post-partum
Outcome measures
| Measure |
Dry Cord Care
n=19308 Participants
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Chlorhexidine Cord Care
n=18450 Participants
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
|---|---|---|
|
All-cause Neonatal Mortality
Neonatal mortality
|
263 participants
|
282 participants
|
|
All-cause Neonatal Mortality
Survived to day 28
|
19045 participants
|
18168 participants
|
PRIMARY outcome
Timeframe: 28 days post-partumPopulation: All liveborn neonates who survived the first 24 hours after delivery
All-cause mortality by day 28 of life among newborns who survive at least the first day of life
Outcome measures
| Measure |
Dry Cord Care
n=19266 Participants
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Chlorhexidine Cord Care
n=18424 Participants
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
|---|---|---|
|
All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
Neonatal mortality
|
186 neonates who survived first 24 hours
|
200 neonates who survived first 24 hours
|
|
All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life
Survived to day 28
|
19080 neonates who survived first 24 hours
|
18224 neonates who survived first 24 hours
|
SECONDARY outcome
Timeframe: 28 days postpartumOmphalitis, or umbilical cord infection, defined as: * presence of umbilical cord pus and mild, moderate or severe redness * moderate or severe redness without the presence of umbilical cord pus
Outcome measures
| Measure |
Dry Cord Care
n=19346 Participants
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Chlorhexidine Cord Care
n=18510 Participants
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
|---|---|---|
|
Incidence of Omphalitis
No omphalitis
|
19228 neonates
|
18428 neonates
|
|
Incidence of Omphalitis
Omphalitis
|
118 neonates
|
82 neonates
|
SECONDARY outcome
Timeframe: 28 days postpartumThe location where mothers gave birth (home versus a health facility) will be compared to their planned delivery location.
Outcome measures
| Measure |
Dry Cord Care
n=19346 Participants
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Chlorhexidine Cord Care
n=18510 Participants
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
|---|---|---|
|
Place of Delivery
Home Delivery
|
6682 Participants
|
6509 Participants
|
|
Place of Delivery
Facility Delivery
|
12204 Participants
|
11456 Participants
|
|
Place of Delivery
Other
|
128 Participants
|
190 Participants
|
|
Place of Delivery
Missing
|
332 Participants
|
355 Participants
|
SECONDARY outcome
Timeframe: 28 days postpartumPopulation: Women enrolled in the ZamCAT study and delivery location known. Please note these are different denominators reported as this analysis is not based on intervention randomization, but rather an analysis focused on women's location of childbirth. Therefore, the number of women included in this analysis is based on a subset of all women enrolled.
Health facility characteristics and maternal decision making factors that influence choice of delivery location (health facility vs. home delivery)
Outcome measures
| Measure |
Dry Cord Care
n=13255 Participants
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Chlorhexidine Cord Care
n=23815 Participants
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
|---|---|---|
|
Factors Influencing Delivery Location
Same Location as Prior Delivery
|
2082 Participants
|
3198 Participants
|
|
Factors Influencing Delivery Location
Family/Social Expectations
|
990 Participants
|
1255 Participants
|
|
Factors Influencing Delivery Location
Need for Skilled Attendance12991
|
5693 Participants
|
12991 Participants
|
|
Factors Influencing Delivery Location
Financial Constraints
|
1249 Participants
|
1823 Participants
|
|
Factors Influencing Delivery Location
Physical Distance
|
3930 Participants
|
6345 Participants
|
|
Factors Influencing Delivery Location
Relationship with Provider
|
429 Participants
|
572 Participants
|
|
Factors Influencing Delivery Location
Safety for Mother/Baby
|
5911 Participants
|
14129 Participants
|
|
Factors Influencing Delivery Location
Other
|
803 Participants
|
1480 Participants
|
|
Factors Influencing Delivery Location
Missing
|
770 Participants
|
1364 Participants
|
SECONDARY outcome
Timeframe: 12 months after study initiationPopulation: Health facilities
Characterization of the health services available to pregnant women, postpartum women and their offspring as assessed by comprehensive health facility and health worker surveys. This data was assessed and reported on 100 facilities (10 district hospitals and 90 health facilities).
Outcome measures
| Measure |
Dry Cord Care
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
Chlorhexidine Cord Care
n=100 Health facilities
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
|---|---|---|
|
Health Facility Characteristics
Basic emergency obstetrical and newborn care
|
—
|
6 Health facilities
|
|
Health Facility Characteristics
No basic emergency obstetrical and newborn care
|
—
|
94 Health facilities
|
Adverse Events
Chlorhexidine Cord Care
Serious events: 0 serious events
Other events: 9 other events
Deaths: 282 deaths
Dry Cord Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 263 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chlorhexidine Cord Care
n=18510 participants at risk
Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates.
Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
|
Dry Cord Care
n=19346 participants at risk
Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy.
Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
|
|---|---|---|
|
Eye disorders
Chlorhexidine ocular exposure
|
0.01%
1/18510 • Number of events 1 • Adverse event data were collected during the 1 month follow up period past delivery.
Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.
|
0.00%
0/19346 • Adverse event data were collected during the 1 month follow up period past delivery.
Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.
|
|
Skin and subcutaneous tissue disorders
Chlorhexidine-related adverse events
|
0.04%
8/18510 • Number of events 8 • Adverse event data were collected during the 1 month follow up period past delivery.
Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.
|
0.00%
0/19346 • Adverse event data were collected during the 1 month follow up period past delivery.
Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.
|
Additional Information
Katherine Semrau (Epidemiologist, co-PI)
Ariadne Labs|BWH & HSPH
Phone: 6177805311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60