Intrapartum MortalityNCT01994304
Assessment and Evaluation of the Safe Childbirth Checklist --Phase II
A study testing SCC in people with Intrapartum Mortality, run by Public Health Foundation of India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrapartum Mortality
- What is being tested?
- SCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200,000 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India
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).
Read the 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.
- Conditions
- Intrapartum Mortality
- Being tested
- SCC
- Keywords
- Safe Childbirth Checklist, Intrapartum mortality, Quality of Institutional delivery care, Maternal & newborn care practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCCBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| No safe childbirth checklist | No intervention | The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur |
| Safe Childbirth Checklist | Active comparator | The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu Receives: Behavioral: SCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal mortality
This evaluation will independently estimate the effectiveness of the Safe Childbirth Checklist in reduce perinatal mortality by 15% in the intervention areas
Measured: 18 months (Nov-2013 to May-2015)
Secondary outcomes (1)
Morbidity rates for infants and mothers
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)
Measured: 18 months (Nov-2013 to May-2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrapartum MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of India
- Sponsor type
- University, hospital or other
- Collaborators
- UBS Optimus Foundation, The Children's Investment Fund Foundation
- Responsible party
- Principal investigator, Dr. Beena Varghese, Public Health Foundation of India
- Investigators
- Beena Varghese, PhD, Principal investigator, Public Health Foundation of India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994304
- Sponsor's protocol ID
- SCC--P2
- Status last verified
- Sep 2016
- First submitted
- 13 Nov 2013
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Varghese B, Copas A, Kumari S, Bandyopadhyay S, Sharma J, Saha S, Yadav V, Kumar S. Does the safe childbirth checklist (SCC) program save newborn lives? Evidence from a realistic quasi-experimental study, Rajasthan, India. Matern Health Neonatol Perinatol. 2019 Mar 1;5:3. doi: 10.1186/s40748-019-0098-4. eCollection 2019.
PubMed 30867935
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India
- ClinicalTrials.gov ID
- NCT01994304
- Acronym / sponsor ID
- SCC--P2
- Conditions
- Intrapartum Mortality
- Keywords
- Safe Childbirth Checklist, Intrapartum mortality, Quality of Institutional delivery care, Maternal & newborn care practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- Public Health Foundation of IndiaUniversity, hospital or other
- Collaborators
- UBS Optimus Foundation, The Children's Investment Fund Foundation
- Study start
- Jun 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No safe childbirth checklist | No intervention | –The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur |
| Safe Childbirth Checklist | Active comparator | Behavioral: SCCThe selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCCThe 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). | Behavioural | Safe Childbirth Checklist |
Primary outcome
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
1 secondary outcome
Morbidity rates for infants and mothers
Time frame: 18 months (Nov-2013 to May-2015)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 30867935Varghese B, Copas A, Kumari S, Bandyopadhyay S, Sharma J, Saha S, Yadav V, Kumar S. Does the safe childbirth checklist (SCC) program save newborn lives? Evidence from a realistic quasi-experimental study, Rajasthan, India. Matern Health Neonatol Perinatol. 2019 Mar 1;5:3. doi: 10.1186/s40748-019-0098-4. eCollection 2019.
- Related InfoLink provided by the sponsor.
- Saving lives through checklistLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beena Varghese, PhD principal investigator
Public Health Foundation of India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCC in people with Intrapartum Mortality, run by Public Health Foundation of India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal mortality (time frame: 18 months (Nov-2013 to May-2015)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.