Assessment and Evaluation of the Safe Childbirth Checklist --Phase II
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|ClinicalTrials.gov Identifier: NCT01994304|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : September 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intrapartum Mortality||Behavioral: SCC||Not Applicable|
The Safe Childbirth Checklist (SCC), a tool that provides reminders and is a job aid to health care providers is a new maternal and newborn care intervention that is being implemented by the Government of Rajasthan with technical support from Jhpeigo. SCC is thus expected to improve the quality of delivery care practices and was implemented in Community Health Centres (CHCs) and District Hospitals (DHs) across seven districts in Rajasthan over a two-year time period (2013 to 2015). PHFI independently evaluated the effectiveness and cost-effectiveness of the SCC in preventing intrapartum (stillbirths and very early neonatal deaths within 3-days after births). Data on 137,000 births was collected over a period of 17 months (November 2013 to April 2015) from 34 facilities with sick newborn care centres (SNC).
Facility records were main source of outcome data. Labor room provided data on stillbirths whereas information on very early neonatal deaths came from SNCs. All Data collection and management was done through software specifically developed for this purpose.
For a better understanding on how maternal and neonatal complications are diagnosed and managed at the facility, in-depth interviews were conducted with the service providers (specialists, physicians, labor room staff nurses, and pharmacists) from the District hospitals and CHCs. In addition, interviews focused on understanding the use, acceptability and feasibility of the SCC among various types of providers.
Cost of this intervention was estimated from a program perspective, and cost effectiveness in terms of cost per perinatal death prevented was calculated.
Preliminary analysis has found that SCC is significantly associated with a 11% reduction in intrapartum deaths.
Permission for this study and data collection has been obtained from the Department of Health and Family Welfare, Government of Rajasthan.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||June 2016|
No Intervention: No safe childbirth checklist
The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur
Active Comparator: Safe Childbirth Checklist
The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu
The intervention involves introducing and orienting health providers on the SCC, facilitating availability of a specific set of commodities and regular targeted supervision. These are expected to improve adherence to life saving interventions immediately before, during and after birth, and reduce intrapartum mortality (still births and very early neonatal deaths).
- Perinatal mortality [ Time Frame: 18 months (Nov-2013 to May-2015) ]This evaluation will independently estimate the effectiveness of the Safe Childbirth Checklist in reduce perinatal mortality by 15% in the intervention areas
- Morbidity rates for infants and mothers [ Time Frame: 18 months (Nov-2013 to May-2015) ]
We determine checklist-related morbidity rates for infants and mothers at the intervention facilities by observing the following:
- Level of Practices -use of partograph or recording of events; active management of third stage labor (AMTSL); early initiation of breast feeding; use of antihypertensives/magnesium sulphate for mothers and use of antibiotics for mother and neonate
- Levels of neonatal morbidity (low birth weight/prematurity, asphyxia, sepsis), maternal morbidity (Post partum haemorrhage, sepsis, eclampsia etc)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994304
|Public Health Foundation of India|
|New Delhi, India, 110070|
|Principal Investigator:||Beena Varghese, PhD||Public Health Foundation of India|