Neonatal DeathNCT02605369
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
A study testing Intervention arm: An integrated package in people with Neonatal Death and Preterm Birth, run by Makerere University at 1 site in Uganda.
Trial summary
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Death, Preterm Birth, Low Birthweight
- What is being tested?
- Intervention arm: An integrated package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,877 participants
- Where
- 1 siteUganda
- Study dates
- 3 Jan 2018to 28 Feb 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women at 28 or more weeks of gestation
- Residence in the selected clusters
- Pregnant women under 18 years of age will be included since they are considered as emancipated minors in Uganda
Who cannot join
- Intention to move from the study area within one year
- Psychiatric ailments that may inhibit the informed consent process
Trial locations and contacts
1 site in 1 country.
About this study
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.
- Conditions
- Neonatal Death, Preterm Birth, Low Birthweight, Neonatal Hypoglycemia
- Being tested
- Intervention arm: An integrated package
- Keywords
- Facility births
- Medical subject headings
- Perinatal Death, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: An integrated packageBehavioural
See description in previous column
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: An integrated package | Experimental | Pregnant women in the intervention clusters will receive an integrated package consisting of peer support for facility based births by pregnancy buddies, mama kits and mobile phone messages. These components will all aim at mitigating the three delays and increasing the proportion of facility based births. Receives: Behavioral: Intervention arm: An integrated package |
| Control arm: Standard of care | No intervention | Pregnant women in the control clusters will continue to receive the standard of care for pregnant women according to Ugandan Ministry of Health guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facility based birth
Delivery at a health facility
Measured: Day 1
Secondary outcomes (5)
Neonatal death
Death within the first month of life
Measured: Day 28
Timely initiation of breastfeeding
Initiation of breastfeeding with the first hour after birth
Measured: Up-to one hour after birth
Severe illness
Severe illness within the first month of life
Measured: Day 28
The percent of newborns attended by a health care pro-vider during the first 48 hours following birth
Proportion of babies seen by a health care work in the first 48 hours after birth
Measured: Up-to 48 hours after birth
The percent of newborns attended by a health care pro-vider during the first 7 days following birth
Proportion of babies seen by a health care work in the first one week after birth
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start3 Jan 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal DeathStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre For International Health
- Responsible party
- Sponsor
- Investigators
- Victoria Nankabirwa, MD, MPH, PhD, Principal investigator, Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere UniversityJames K Tumwine, MD, PhD, Principal investigator, Makerere UniversityGrace Ndeezi, MD, PhD, Principal investigator, Makerere UniveristyThorkild Tylleskar, MD, PhD, Principal investigator, University of BergenPaul Wako, MD, PhD, Principal investigator, Busitema UniversityJoyce Kaducu, Principal investigator, Gulu UniversityJino Meleby, Principal investigator, University of JubaFrederik Froen, MD, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605369
- Sponsor's protocol ID
- 2015-121
- Status last verified
- Oct 2023
- First submitted
- 12 Nov 2015
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study will be available on reasonable request
Publications
Nankabirwa V, Mukunya D, Ndeezi G, Odongkara B, Arach AA, Achora V, Mugenyi L, Sebit MB, Wandabwa JN, Waako P, Tylleskar T, Tumwine JK. Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda. BMJ Open. 2024 Feb 7;14(2):e070798. doi: 10.1136/bmjopen-2022-070798.
PubMed 38326267Mukunya D, Tumwine JK, Nankabirwa V, Odongkara B, Tongun JB, Arach AA, Tumuhamye J, Napyo A, Zalwango V, Achora V, Musaba MW, Ndeezi G, Tylleskar T. Neonatal hypothermia in Northern Uganda: a community-based cross-sectional study. BMJ Open. 2021 Feb 11;11(2):e041723. doi: 10.1136/bmjopen-2020-041723.
PubMed 33574146
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
- ClinicalTrials.gov ID
- NCT02605369
- Acronym / sponsor ID
- 2015-121
- Conditions
- Neonatal Death, Preterm Birth, Low Birthweight, Neonatal Hypoglycemia
- Keywords
- Facility births
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,877 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Centre For International Health
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 16 Nov 2015 (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.
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: An integrated package | Experimental | Behavioral: Intervention arm: An integrated packagePregnant women in the intervention clusters will receive an integrated package consisting of peer support for facility based births by pregnancy buddies, mama kits and mobile phone messages. These components will all aim at mitigating the three delays and increasing the proportion of facility based births. |
| Control arm: Standard of care | No intervention | –Pregnant women in the control clusters will continue to receive the standard of care for pregnant women according to Ugandan Ministry of Health guidelines |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women at 28 or more weeks of gestation
- Residence in the selected clusters
- Pregnant women under 18 years of age will be included since they are considered as emancipated minors in Uganda
Key exclusion criteria (2 listed)
- Intention to move from the study area within one year
- Psychiatric ailments that may inhibit the informed consent process
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 |
|---|---|---|
| Intervention arm: An integrated packageSee description in previous column | Behavioural | Intervention arm: An integrated package |
Primary outcome
Facility based birth
Time frame: Day 1
Delivery at a health facility
5 secondary outcomes
Neonatal death
Time frame: Day 28
Timely initiation of breastfeeding
Time frame: Up-to one hour after birth
Severe illness
Time frame: Day 28
The percent of newborns attended by a health care pro-vider during the first 48 hours following birth
Time frame: Up-to 48 hours after birth
The percent of newborns attended by a health care pro-vider during the first 7 days following birth
Time frame: 1 week
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 10 Oct 2023.
- Derived from this study: PubMed 38326267Nankabirwa V, Mukunya D, Ndeezi G, Odongkara B, Arach AA, Achora V, Mugenyi L, Sebit MB, Wandabwa JN, Waako P, Tylleskar T, Tumwine JK. Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda. BMJ Open. 2024 Feb 7;14(2):e070798. doi: 10.1136/bmjopen-2022-070798.
- Derived from this study: PubMed 33574146Mukunya D, Tumwine JK, Nankabirwa V, Odongkara B, Tongun JB, Arach AA, Tumuhamye J, Napyo A, Zalwango V, Achora V, Musaba MW, Ndeezi G, Tylleskar T. Neonatal hypothermia in Northern Uganda: a community-based cross-sectional study. BMJ Open. 2021 Feb 11;11(2):e041723. doi: 10.1136/bmjopen-2020-041723.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study will be available on reasonable request
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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.
Victoria Nankabirwa, MD, MPH, PhD principal investigator
Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University
James K Tumwine, MD, PhD principal investigator
Makerere University
Grace Ndeezi, MD, PhD principal investigator
Makerere Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: An integrated package in people with Neonatal Death and Preterm Birth, run by Makerere University at 1 site in Uganda.
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 3 inclusion and 2 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 10 Oct 2023. 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 Uganda. 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?
Facility based birth (time frame: Day 1). 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 NCT02605369, which also lists 2 linked publications.
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 10 Oct 2023.