Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment and Evaluation of the Safe Childbirth Checklist --Phase II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994304
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : September 27, 2016
Sponsor:
Collaborators:
UBS Optimus Foundation
The Children's Investment Fund Foundation
Information provided by (Responsible Party):
Dr. Beena Varghese, Public Health Foundation of India

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design with data collection from 34 facilities across six intervention districts and four control districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in intrapartum mortality. Data on this was collected over a period of 17 months (November 2013 to April 2015).

Condition or disease Intervention/treatment Phase
Intrapartum Mortality Behavioral: SCC Not Applicable

Detailed Description:

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Behavioral: SCC
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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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:

    1. 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
    2. Levels of neonatal morbidity (low birth weight/prematurity, asphyxia, sepsis), maternal morbidity (Post partum haemorrhage, sepsis, eclampsia etc)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)

Exclusion Criteria:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
India
Public Health Foundation of India
New Delhi, India, 110070
Sponsors and Collaborators
Public Health Foundation of India
UBS Optimus Foundation
The Children's Investment Fund Foundation
Investigators
Layout table for investigator information
Principal Investigator: Beena Varghese, PhD Public Health Foundation of India
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Dr. Beena Varghese, Sr. Health Economist and Additional Professor, Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT01994304    
Other Study ID Numbers: SCC--P2
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by Dr. Beena Varghese, Public Health Foundation of India:
Safe Childbirth Checklist
Intrapartum mortality, Quality of Institutional delivery care
Maternal & newborn care practices