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AzTrials

Quality of CareNCT03589625

Electricity Access and Maternal Care in Rural Health Facilities in Uganda

A study testing Solar Suitcase in people with Quality of Care, run by Harvard School of Public Health (HSPH) at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will conduct a stepped wedge cluster-randomized controlled trial in maternity care facilities in Uganda to evaluate the impact of the provision of a reliable light source on the quality of delivery care provided. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Quality of Care
What is being tested?
Solar Suitcase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,268 participants
Where
1 siteUganda
Study dates
13 Jun 2018to 28 Feb 2020
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 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women who are admitted for labor and delivery at participating facilities.
  • Women aged 16 years or older.
  • government health facilities level 2, 3, or 4
  • are open 24 hours a day
  • conduct deliveries at night
  • have unreliable electricity (have either no source of electricity, or have only 1 functional source of electricity and experience blackouts at least several times a week and had power available only sometimes in the past week).

Who cannot join

  • Pregnant women who present to participating facilities for abortion or abortion-related complications, miscarriage, ectopic pregnancy, antenatal or postnatal complications of pregnancy (not an observation of labor)
  • Women who are immediately transferred to another hospital, or are taken straight to surgical theatre (limited or no period of observation possible)
  • Women who deliver at home but are brought to the facility for any complication.
  • Women who deliver outside the maternity ward or delivery area
  • Women who deliver in ambulance while on the way to the facility (woman admitted in the facility for placenta removal)
  • Women who have not given consent
Show all 9Show fewer
  • Health worker objects to the observation.
  • For eligibility of health facility:
  • facility already has a Solar Suitcase

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Innovations for Poverty Action

    Kampala

Other trials in Uganda

About this study

Official title: Evaluation of the Impact of the 'Solar Suitcase' Installation in Healthcare Facilities in Uganda on Quality of Care During Labor and Delivery and Reliability of Electricity

The investigators will conduct a stepped wedge cluster-randomized controlled trial in maternity care facilities in Uganda to evaluate the impact of the provision of a reliable light source on the quality of delivery care provided. The facility-level intervention is the installation of a "Solar Suitcase", a complete solar electric system providing essential lighting and power for charging phones and small medical devices and a fetal doppler. The intervention will be rolled-out sequentially to all facilities over two time periods, in a randomized order.

Read the detailed description

Ensuring universal access to electricity is essential for global development. In the health sector, lack of reliable light and electricity is a major challenge for health workers when conducting deliveries at night. However, there is very little evidence of the impact of improving access to reliable electrification at maternity facilities on the quality of maternity care they provide.

This stepped wedge cluster-randomized trial will evaluate the impact of a reliable light and electricity source - the "Solar Suitcase" - on outcomes of availability and brightness of light, the quality of maternal care provided, and health worker satisfaction. The study will take place in rural health facilities conducting deliveries in Uganda. The eligible facilities have either no connection to electricity or a modern light source or have reported to have very unreliable light (blackouts occur frequently).

The intervention is a "Solar Suitcase", provided by the non-governmental organization "We Care Solar". The Solar Suitcases are complete solar electric systems that provide essential lighting and power for charging phones and small medical devices. Data collection will include direct observation of deliveries during daytime and nighttime hours, as well as interviews with facility staff. The intervention will be implemented in about 30 facilities in a step process, whereby at each 'step', half of the facilities (selected randomly) will receive the intervention.

Data will be collected at three time points: a baseline period in which no facilities have received the intervention, a midline period in which the first group of facilities has received the intervention but the other half has not, and an endline period in which all facilities have received the intervention.

In addition, facility-level data will be collected at three time points over a 9-month period after the completion of the endline. This data will be used to monitor delivery and ANC volumes at facilities.

Conditions
Quality of Care
Being tested
Solar Suitcase
Keywords
electricity and health, maternal health, quality of care, solar power

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solar SuitcaseOther

    The intervention is a "Solar Suitcase". The Solar Suitcase comes with: 2 LED lights, 1 battery, 1 aluminum glass 100 watt solar panel, 2 rechargeable LED headlamps, 1 universal cell phone charger, 1 USB adapter, 1 fetal Doppler, 1 AA/AAA battery charger and expansion box (provides 2 additional lights).

    Installers will teach health workers how to use and maintain the Solar Suitcase on the day of installation. Within one week following installation, the contractor will contact the facility over the phone and/or in-person to check if there are any problems with the Suitcase. Additional checks will be made to ensure the solar suitcase is functioning and being used properly.

Study groups in NCT03589625
Study groupRoleWhat they receive
Solar Suitcase Installation First GroupExperimentalFacilities will receive the installation of the Solar Suitcase shortly after baseline data collection.
Receives: Other: Solar Suitcase
Solar Suitcase Installation Second GroupExperimentalFacilities will act as a comparator for experimental group 1 and then will receive the installation of the Solar Suitcase shortly after midline data collection.
Receives: Other: Solar Suitcase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average brightness of room during labor and delivery as measured by observer recorded questionnaire

    Scale is scored as 1: Very Bright; 2: Somewhat Bright; 3: Dim; 4: Pitch Black. Variable is binary indicator for "very bright" or "somewhat bright" throughout delivery

    Measured: up to 6 months after installation

  2. Satisfactory light source used for entire delivery as measured by observer recorded questionnaire

    Satisfactory light source is a variable equal to 1 if observation occurs without daylight and facility is using grid, solar or functional generator and zero if using kerosene, candle, torch, etc. Variable is always equal to 1 during daylight.

    Measured: up to 6 months after installation

  3. Adequate Light as measured by observer recorded questionnaire

    Binary variable equal to 1 if light is from a satisfactory source and is "bright" ("very bright" or "somewhat bright") for duration of delivery observation.

    Measured: up to 6 months after installation

  4. 20-item quality of maternal care index of essential actions to be performed by provider during labor and delivery as measured by observer recorded questionnaire

    Quality of care index is based on essential actions providers must perform during the course of labor and delivery, as described in Tripathi et al. (2015). Score is the fraction of 20 items, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.

    Measured: up to 6 months after installation

  5. 37-item quality of maternal care index of essential actions to be performed by provider during labor and delivery as measured by observer recorded questionnaire

    Quality of care index is based on the essential actions providers must perform during the course of labor and delivery, derived from the Maternal and Child Health Integrated Program (MCHIP). It includes the 20 items from Tripathi et al. (2015) plus an additional 17 quality of care items from MCHIP (2013). Score is fraction of the 37 items, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.

    Measured: up to 6 months after installation

  6. 6-item delays in care index as measured by observer recorded questionnaire

    Index including:

    1. Time between facility arrival and first contact with health worker (mins) ii) Time between facility arrival and first assessment (mins) iii) Time between delivery and uterotonic (mins) iv) Time between delivery and assessment of perineal and vaginal lacerations (mins) v) Time between delivery and drying baby with towel (mins) vi) Time between delivery and initiation of breastfeeding (mins) Score is average of the 6 items measured in minutes, with lower values indicating reduced delays in quality of maternal care. Range from 0 to 120 minutes.

    Measured: up to 6 months after installation

  7. Health Worker Satisfaction with Electricity as measured by health worker survey

    Responses on a 1-5 scale with 1: Strongly Disagree, 2: Disagree, 3: Neutral (Neither Agree nor Disagree), 4: Agree, 5: Strongly Agree

    Worker Satisfaction with Electricity is a binary variable equal to 1 if strongly agree with both:

    1. I am satisfied with the availability and brightness of light in this facility. ii) I am satisfied with the availability of electricity in this facility

    Measured: up to 6 months after installation

  8. Overall job satisfaction index as measured by health worker survey

    Responses on a 1-5 scale with 1: Strongly Disagree, 2: Disagree, 3: Neutral (Neither Agree nor Disagree), 4: Agree, 5: Strongly Agree

    Overall job satisfaction index is the mean score (1-5) of the 4 below components:

    1. These days, I feel motivated to work as hard as I can. ii) Overall, I am satisfied with my job. iii) Overall, the morale level at my department is good iv) I plan on staying at this position for the next year.

    Measured: up to 6 months after installation

Secondary outcomes (72)
  1. Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire

    Scale is scored as 1: Very Bright; 2: Somewhat Bright; 3: Dim; 4: Pitch Black

    Measured: up to 6 months after installation

  2. Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire

    Satisfactory light source defined in Primary Outcome 2.

    Measured: up to 6 months after installation

  3. Consistent satisfactory light source as measured by observer recorded questionnaire

    Variable equal to 1 if no interruptions of > 2 hours in satisfactory light source during observed deliveries.

    Measured: up to 6 months after installation

  4. Fetal Doppler Use as measured by observer recorded questionnaire

    Number of times the provider used a fetal doppler during labor and delivery

    Measured: up to 6 months after installation

  5. Phone availability as measured by observer recorded questionnaire

    Phone is available and on for deliveries

    Measured: up to 6 months after installation

  6. APGAR Score Assigned as measured by observer recorded questionnaire

    Provider assigns any APGAR score (binary variable equal to 1 if provider assigns an APGAR score (range of 0-10), and equal to 0 if no APGAR score is assigned.

    Measured: up to 6 months after installation

  7. Basic emergency obstetric care signal functions as measured by facility assessment

    Facility reported performance of basic emergency obstetric care signal functions in the past three months. Measure includes the number of signal functions performed from:

    1. Removal of retained products of conception
    2. Parenteral oxytocin for maternal hemorrhage
    3. Parenteral magnesium sulfate for (pre-) eclampsia
    4. Manual removal of placenta
    5. Parenteral antibiotics for maternal infection
    6. Assisted vaginal delivery

    Measured: up to 6 months after installation

  8. Basic emergency newborn care signal functions as measured by facility assessment

    Facility reported performance of basic emergency newborn care signal functions in the past three months. Measure includes the number of signal functions performed from:

    1. Antibiotics for preterm or prolonged PROM
    2. Corticosteroids in preterm labor
    3. Resuscitation with bag and mask for non-breathing baby
    4. Kangaroo Mother Care for premature/very small babies
    5. Alternative feeding if baby unable to breastfeed
    6. Injectable antibiotics for neonatal sepsis
    7. PMTCT if HIV-positive mother

    Measured: up to 6 months after installation

  9. Routine obstetric care signal functions as measured by facility assessment

    Facility reported universal practice of routine obstetric care signal functions. Measure includes the number of signal functions performed from:

    1. Infection control (provider hand-washing before patient exam in labor, new sterile gloves before every vaginal examination)
    2. Use of partograph to monitor labor
    3. Routine practice of active management of the third stage of labor

    Measured: up to 6 months after installation

  10. Routine newborn care signal functions as measured by facility assessment

    Facility reported universal practice of routine newborn care signal functions. Measure includes the number of signal functions performed from:

    1. Thermal protection (newborn dried immediately, skin-to-skin, no bath/delayed>6 hours)
    2. Exclusive breastfeeding initiated within 1 hour of birth
    3. Hygienic cord care (cord cut with sterile blade/scissors; chlorhexidine or nothing applied to stump)

    Measured: up to 6 months after installation

  11. Time between delivery and when suturing began (minutes) as measured by observer recorded questionnaire

    Observed time between delivery and when provider began suturing lacerations, if needed.

    Measured: up to 6 months after installation

  12. 4-item quality of suturing index as measured by observer recorded questionnaire

    Index constructed from the following variables:

    • Health worker explains to woman what is happening (binary)
    • Health worker cleans area prior to suturing with antiseptic solution (binary)
    • Health worker prepares instruments/sutures on a sterile surface (binary)
    • Health worker sutures episiotomy or tears appropriately in layers. (binary) Score is fraction of 4 items, yielding a range of 0-1, with higher score indicating better quality of suturing.

    Measured: up to 6 months after installation

  13. 10-item patient treatment index as measured by observer recorded questionnaire

    Patient treatment/inter-personal quality care index, based on Kruk et al. (2014) including whether health worker: shouted/scolded patient, threatened to withhold treatment, ignored/left patient, did not answer questions, was not present when delivery began, slapped/beat mother, stitched episiotomy without anesthesia, demanded payment inappropriately, requested bribe, did not provide privacy to mother. Fraction of items that were NOT performed, yielding a range of 0-1, with higher scores indicating better treatment of patients.

    Measured: up to 6 months after installation

  14. 14-item Partograph Completeness index as measured by observer recorded questionnaire

    Index of variables (from MCHIP (2013) tool capturing completeness of recording on partograph). Fraction of 14 items completed on partograph (all binary variables), yielding a range of 0-1, with higher values indicating more completeness.

    Measured: up to 6 months after installation

  15. Time between contractions as measured by observer recorded questionnaire

    Time between contractions at first exam (mins)

    Measured: up to 6 months after installation

  16. Dilation at first exam as measured by observer recorded questionnaire

    Degree of dilation at woman's first exam (cm)

    Measured: up to 6 months after installation

  17. Monthly Delivery Volumes as measured by facility register

    Average Number of Monthly Deliveries

    Measured: up to 6 months after installation

  18. Monthly Nighttime Delivery Volumes as measured by facility register

    Average Number of Nighttime Deliveries per Month

    Measured: up to 6 months after installation

  19. Monthly ANC Volumes as measured by facility register

    Average Number of Antenatal Clients per Month

    Measured: up to 6 months after installation

  20. Monthly Referral Volumes as measured by facility register

    Average Number of Monthly Referrals Out of Facility for Mothers and Newborns

    Measured: up to 6 months after installation

  21. Sensor Brightness as measured by sensor

    Recorded brightness at sensor sight in the two hours around delivery of baby.

    Measured: up to 6 months after installation

  22. Depletion of Solar Suitcase Battery Based on Voltage as measured by sensor

    Average difference between solar suitcase load voltage in evening and morning (based on sensor)

    Measured: up to 6 months after installation

  23. Depletion of Solar Suitcase Battery Based on Charge Time as measured by sensor

    Average time between morning and when the solar suitcase is fully charged, based on sensor

    Measured: up to 6 months after installation

  24. Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire

    Fraction of deliveries in which enumerator recorded usage of suitcase

    Measured: up to 6 months after installation

  25. Health Worker Assessment of Overhead Light Availability as measured by health worker survey

    Health worker response (1-5) on the following scale: 1: No overhead light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question:

    "In general, how would you rate the availability of overhead light for maternal and newborn care (deliveries) in this facility at night?"

    Measured: up to 6 months after installation

  26. Health Worker Assessment of Task Light Availability as measured by health worker survey

    Health worker response (1-5) on the following scale: 1: No procedure/task light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question:

    "In general, how would you rate the availability of procedure/task light for maternal and newborn care (deliveries) in this facility at night?"

    Measured: up to 6 months after installation

  27. Health Worker Assessment of Overhead Light Brightness as measured by health worker survey

    Health worker response (1-5) on the following scale: 1: No overhead light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question: "In general, when the overhead light is on, how would you rate the quality of light (brightness) for maternal and newborn care (deliveries) in this facility at night?"

    Measured: up to 6 months after installation

  28. Health Worker Assessment of Task Light Brightness as measured by health worker survey

    Health worker response (1-5) on the following scale: 1: No procedure/task light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question: "In general, when the procedure/task light is on, how would you rate the quality of light (brightness) for maternal and newborn care (deliveries) in this facility at night?"

    Measured: up to 6 months after installation

  29. 14-item index of Health worker assessment of impact of blackouts on their ability to perform job functions as measured by health worker survey

    Index of items measuring health worker assessment of impact of blackouts in facility on ability to conduct their job, including how often health worker: conducted deliveries without overhead light; had to hold torch in hand to see patient; experienced lack of light that affected normal care provided; delayed care; feared to move around facility; was affected in ability to suture, find/use equipment, conduct examinations of mother, provide emergency care, provide newborn care, monitor fetal heartrate, administer medication, clean up after delivery, manage infection control. Response to items scored (1-5) on following scale: 1. Every delivery, 2. Most, 3. Some, 4. Few, or 5. Never. Overall score measured as average of 14 items, yielding a range of 1-5.

    Measured: up to 6 months after installation

  30. Initial exam Bleeding Assessment as measured by observer recorded questionnaire

    Provider asks whether woman has experienced vaginal bleeding during current pregnancy (binary)

    Measured: up to 6 months after installation

  31. Initial exam Headaches/Blurred Vision Assessment as measured by observer recorded questionnaire

    Provider asks whether woman has experienced headaches and/or blurred vision during current pregnancy (binary)

    Measured: up to 6 months after installation

  32. HIV testing as measured by observer recorded questionnaire

    Provider offers woman an HIV test or checks her HIV status (binary)

    Measured: up to 6 months after installation

  33. Takes Pulse as measured by observer recorded questionnaire

    Provider takes pulse of mother during initial exam (binary)

    Measured: up to 6 months after installation

  34. Takes Blood Pressure as measured by observer recorded questionnaire

    Provider takes both systolic and diastolic blood pressure measurements of mother during initial exam (binary)

    Measured: up to 6 months after installation

  35. Wears Sterile Gloves as measured by observer recorded questionnaire

    Provider wears sterile gloves for initial vaginal exam (binary)

    Measured: up to 6 months after installation

  36. Communication with Patient as measured by observer recorded questionnaire

    At least once, explains what will happen in labour to woman and/or her support person. (binary)

    Measured: up to 6 months after installation

  37. Partograph Use as measured by observer recorded questionnaire

    Provider starts partograph to monitor progress of labour. (binary)

    Measured: up to 6 months after installation

  38. Hand Washing as measured by observer recorded questionnaire

    Provider washes his/her hands with soap and water or uses alcohol hand rub prior to every examination of woman. (binary)

    Measured: up to 6 months after installation

  39. Preparation of Uterotonic as measured by observer recorded questionnaire

    Uterotonic is prepared for Active Management of the Third Stage of Labor (AMTSL). (binary)

    Measured: up to 6 months after installation

  40. Preparation of Bag and Mask as measured by observer recorded questionnaire

    Prepares self-inflating ventilation bag and newborn face mask. (binary)

    Measured: up to 6 months after installation

  41. Administration of Oxytocin as measured by observer recorded questionnaire

    After delivery, provider administers 10 IU of IM oxytocin, OR:

    • 5 IU slow push if IV in place
    • 600μg of misoprostol sublingually
    • 600μg misoprostol rectally (binary)

    Measured: up to 6 months after installation

  42. Assessment of Completeness of Placenta as measured by observer recorded questionnaire

    Provider assesses completeness of the placenta and membranes. (binary)

    Measured: up to 6 months after installation

  43. Assessment of Lacerations as measured by observer recorded questionnaire

    Assesses completeness of the placenta and membranes. (binary)

    Measured: up to 6 months after installation

  44. Skin-to-Skin as measured by observer recorded questionnaire

    Provider places baby on mother's abdomen or chest skin-to-skin. (binary)

    Measured: up to 6 months after installation

  45. Drying Newborn as measured by observer recorded questionnaire

    Provider immediately dries baby with towel. (binary)

    Measured: up to 6 months after installation

  46. Cord Clamping as measured by observer recorded questionnaire

    Provider ties or clamps cord. (binary)

    Measured: up to 6 months after installation

  47. Vital Signs Postpartum as measured by observer recorded questionnaire

    Provider takes mother's vital signs after delivery. (binary)

    Measured: up to 6 months after installation

  48. Palpation of Uterus as measured by observer recorded questionnaire

    Provider palpates uterus after delivery of placenta. (binary)

    Measured: up to 6 months after installation

  49. Breastfeeding within 1 Hour as measured by observer recorded questionnaire

    Breastfeeding is initiated within one hour of delivery. (binary)

    Measured: up to 6 months after installation

  50. Initial Exam: Previous Pregnancy Inquiry as measured by observer recorded questionnaire

    Provider asks about complications during previous pregnancies. (binary)

    Measured: up to 6 months after installation

  51. Initial Exam: Hand Washing as measured by observer recorded questionnaire

    Provider washes his/her hands with soap and water or uses alcohol hand rub before initial examination. (binary)

    Measured: up to 6 months after installation

  52. Initial Exam Temperature Assessment as measured by observer recorded questionnaire

    Provider takes mother's temperature during initial exam. (binary)

    Measured: up to 6 months after installation

  53. Initial Exam Fundal Height Assessment as measured by observer recorded questionnaire

    Provider checks fundal height during initial exam. (binary)

    Measured: up to 6 months after installation

  54. Initial Exam Fetal Presentation Assessment as measured by observer recorded questionnaire

    Provider checks fetal presentation by palpation of abdomen. (binary)

    Measured: up to 6 months after installation

  55. Initial Exam Fetal Heart Rate Assessment as measured by observer recorded questionnaire

    Provider checks fetal heart rate with fetoscope/Doppler/ultrasound. (binary)

    Measured: up to 6 months after installation

  56. Initial Exam: Vaginal Examination as measured by observer recorded questionnaire

    Provider performs vaginal examination at initial exam. (binary)

    Measured: up to 6 months after installation

  57. Sterile Gloves for All Exams as measured by observer recorded questionnaire

    Provider wears sterile gloves for all vaginal examinations. (binary)

    Measured: up to 6 months after installation

  58. Preparation for Delivery: Cord ties/clamps and sterile scissors/blade as measured by observer recorded questionnaire

    Prepares disposable cord ties/clamps AND sterile scissors/blade. (binary)

    Measured: up to 6 months after installation

  59. Support of Perineum as measured by observer recorded questionnaire

    Provider supports perineum after baby's head is delivered. (binary)

    Measured: up to 6 months after installation

  60. Cord Traction as measured by observer recorded questionnaire

    Applies traction to the cord while applying suprapubic counter traction. (binary)

    Measured: up to 6 months after installation

  61. Uterine Massage as measured by observer recorded questionnaire

    Provider performs uterine massage immediately following the delivery of the placenta. (binary)

    Measured: up to 6 months after installation

  62. Newborn Temperature as measured by observer recorded questionnaire

    Provider checks newborn's temperature. (binary)

    Measured: up to 6 months after installation

  63. Assistance with Breastfeeding as measured by observer recorded questionnaire

    Provider assists mother with breastfeeding. (binary)

    Measured: up to 6 months after installation

  64. Sterilization of Equipment as measured by observer recorded questionnaire

    Provider sterilizes or uses high-level disinfection for all reusable instruments. (binary)

    Measured: up to 6 months after installation

  65. Waste Disposal as measured by observer recorded questionnaire

    Provider disposes of all contaminated waste in leak-proof containers. (binary)

    Measured: up to 6 months after installation

  66. Hand Hygiene after Clean Up as measured by observer recorded questionnaire

    Provider washes his/her hands with soap and water or uses alcohol hand rub after cleaning up. (binary)

    Measured: up to 6 months after installation

  67. Delay in Facility Arrival as measured by observer recorded questionnaire

    Time between facility arrival and first contact with health worker (mins)

    Measured: up to 6 months after installation

  68. Delay in First Exam as measured by observer recorded questionnaire

    Time between facility arrival and first assessment (mins)

    Measured: up to 6 months after installation

  69. Delay in Uterotonic as measured by observer recorded questionnaire

    Time between delivery and uterotonic (mins)

    Measured: up to 6 months after installation

  70. Delay in Assessment for Lacerations as measured by observer recorded questionnaire

    Time between delivery and assessment of perineal and vaginal lacerations (mins)

    Measured: up to 6 months after installation

  71. Delay in Drying Newborn as measured by observer recorded questionnaire

    Time between delivery and drying baby with towel (mins)

    Measured: up to 6 months after installation

  72. Delay in Breastfeeding Initiation as measured by observer recorded questionnaire

    Time between delivery and initiation of breastfeeding (mins)

    Measured: up to 6 months after installation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2018
  2. Study start13 Jun 2018
  3. Primary completion28 Feb 2020
  4. Study completion28 Feb 2020

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stepped-wedge cluster-randomized trial
Masking
None (open label)
Enrolment
1,268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589625
Sponsor's protocol ID
IRB-18-0406
Status last verified
Jul 2020
First submitted
7 Jun 2018
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: After manuscript publication, fully de-identified data may be shared with researchers upon request.

Publications

  • Tripathi V, Stanton C, Strobino D, Bartlett L. Development and Validation of an Index to Measure the Quality of Facility-Based Labor and Delivery Care Processes in Sub-Saharan Africa. PLoS One. 2015 Jun 24;10(6):e0129491. doi: 10.1371/journal.pone.0129491. eCollection 2015.

    PubMed 26107655
  • USAID. Maternal and Child Health Integrated Program (MCHIP), Washington DC: USAID/Jhpiego; 2013.

  • Chang W, Cohen J, Mwesigwa B, Waiswa P, Rokicki S. Impact of reliable light and electricity on job satisfaction among maternity health workers in Uganda: A cluster randomized trial. Hum Resour Health. 2022 Mar 29;20(1):30. doi: 10.1186/s12960-022-00722-3.

    PubMed 35351147
  • Rokicki S, Mwesigwa B, Schmucker L, Cohen JL. Shedding light on quality of care: a study protocol for a randomized trial evaluating the impact of the Solar Suitcase in rural health facilities on maternal and newborn care quality in Uganda. BMC Pregnancy Childbirth. 2019 Aug 22;19(1):306. doi: 10.1186/s12884-019-2453-x.

    PubMed 31438896

Questions about this trial

What is this clinical trial studying?

A study testing Solar Suitcase in people with Quality of Care, run by Harvard School of Public Health (HSPH) 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 6 inclusion and 9 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 14 Jul 2020. 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?

Average brightness of room during labor and delivery as measured by observer recorded questionnaire (time frame: up to 6 months after installation). The study lists 8 primary outcomes in all. 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 NCT03589625, which also lists 4 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 14 Jul 2020.

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