Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| John Snow, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.
The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.
This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.
The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | In this arm we recruited 2,400 subjects who received Intervention. |
|
| B | Experimental | In this Arm, we recruited 2,400 subjects who received intervention. |
|
| C | Experimental | In this Arm, we recruited 2,400 subjects who received intervention. |
|
| D | No Intervention | In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% Chlorhexidine | Drug | 4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neonatal Omphalitis | By the end of the styudy | |
| Rate of Neonatal Mortality | By the end of the Study |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding rate | By the end of the Study | |
| Rate of Serious Neonatal Infections | By the end of the Study | |
| Utilization of Clean Delivery Kits |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proejct Office | Dadu | Sindh | 75300 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22322126 | Derived | Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hand washing Soap | Other | Hand washing soap was provided to Mothers through TBAs. |
|
| 4% Chlorhexidine | Drug | 4% Chlorhexidine was provided to be applied by Mothers through TBAs. |
|
| By the end of the Study |
| Application Practice of Chlorhexidine | By the end of the Study |
| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided