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.
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.
Study Type
INTERVENTIONAL
Allocation
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.
Innovations for Poverty Action
Kampala, Uganda
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
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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.
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RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,268
Time frame: up to 6 months after installation
6-item delays in care index as measured by observer recorded questionnaire
Index including: i) 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.
Time frame: up to 6 months after installation
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: i) 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
Time frame: up to 6 months after installation
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: i) 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.
Time frame: up to 6 months after installation
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
Time frame: up to 6 months after installation
Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire
Satisfactory light source defined in Primary Outcome 2.
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
Fetal Doppler Use as measured by observer recorded questionnaire
Number of times the provider used a fetal doppler during labor and delivery
Time frame: up to 6 months after installation
Phone availability as measured by observer recorded questionnaire
Phone is available and on for deliveries
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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
Time frame: up to 6 months after installation
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
Time frame: up to 6 months after installation
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
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
Time between contractions as measured by observer recorded questionnaire
Time between contractions at first exam (mins)
Time frame: up to 6 months after installation
Dilation at first exam as measured by observer recorded questionnaire
Degree of dilation at woman's first exam (cm)
Time frame: up to 6 months after installation
Monthly Delivery Volumes as measured by facility register
Average Number of Monthly Deliveries
Time frame: up to 6 months after installation
Monthly Nighttime Delivery Volumes as measured by facility register
Average Number of Nighttime Deliveries per Month
Time frame: up to 6 months after installation
Monthly ANC Volumes as measured by facility register
Average Number of Antenatal Clients per Month
Time frame: up to 6 months after installation
Monthly Referral Volumes as measured by facility register
Average Number of Monthly Referrals Out of Facility for Mothers and Newborns
Time frame: up to 6 months after installation
Sensor Brightness as measured by sensor
Recorded brightness at sensor sight in the two hours around delivery of baby.
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
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
Time frame: up to 6 months after installation
Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire
Fraction of deliveries in which enumerator recorded usage of suitcase
Time frame: up to 6 months after installation
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?"
Time frame: up to 6 months after installation
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?"
Time frame: up to 6 months after installation
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?"
Time frame: up to 6 months after installation
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?"
Time frame: up to 6 months after installation
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.
Time frame: up to 6 months after installation
Initial exam Bleeding Assessment as measured by observer recorded questionnaire
Provider asks whether woman has experienced vaginal bleeding during current pregnancy (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
HIV testing as measured by observer recorded questionnaire
Provider offers woman an HIV test or checks her HIV status (binary)
Time frame: up to 6 months after installation
Takes Pulse as measured by observer recorded questionnaire
Provider takes pulse of mother during initial exam (binary)
Time frame: up to 6 months after installation
Takes Blood Pressure as measured by observer recorded questionnaire
Provider takes both systolic and diastolic blood pressure measurements of mother during initial exam (binary)
Time frame: up to 6 months after installation
Wears Sterile Gloves as measured by observer recorded questionnaire
Provider wears sterile gloves for initial vaginal exam (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
Partograph Use as measured by observer recorded questionnaire
Provider starts partograph to monitor progress of labour. (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
Preparation of Uterotonic as measured by observer recorded questionnaire
Uterotonic is prepared for Active Management of the Third Stage of Labor (AMTSL). (binary)
Time frame: up to 6 months after installation
Preparation of Bag and Mask as measured by observer recorded questionnaire
Prepares self-inflating ventilation bag and newborn face mask. (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
Assessment of Completeness of Placenta as measured by observer recorded questionnaire
Provider assesses completeness of the placenta and membranes. (binary)
Time frame: up to 6 months after installation
Assessment of Lacerations as measured by observer recorded questionnaire
Assesses completeness of the placenta and membranes. (binary)
Time frame: up to 6 months after installation
Skin-to-Skin as measured by observer recorded questionnaire
Provider places baby on mother's abdomen or chest skin-to-skin. (binary)
Time frame: up to 6 months after installation
Drying Newborn as measured by observer recorded questionnaire
Provider immediately dries baby with towel. (binary)
Time frame: up to 6 months after installation
Cord Clamping as measured by observer recorded questionnaire
Provider ties or clamps cord. (binary)
Time frame: up to 6 months after installation
Vital Signs Postpartum as measured by observer recorded questionnaire
Provider takes mother's vital signs after delivery. (binary)
Time frame: up to 6 months after installation
Palpation of Uterus as measured by observer recorded questionnaire
Provider palpates uterus after delivery of placenta. (binary)
Time frame: up to 6 months after installation
Breastfeeding within 1 Hour as measured by observer recorded questionnaire
Breastfeeding is initiated within one hour of delivery. (binary)
Time frame: up to 6 months after installation
Initial Exam: Previous Pregnancy Inquiry as measured by observer recorded questionnaire
Provider asks about complications during previous pregnancies. (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
Initial Exam Temperature Assessment as measured by observer recorded questionnaire
Provider takes mother's temperature during initial exam. (binary)
Time frame: up to 6 months after installation
Initial Exam Fundal Height Assessment as measured by observer recorded questionnaire
Provider checks fundal height during initial exam. (binary)
Time frame: up to 6 months after installation
Initial Exam Fetal Presentation Assessment as measured by observer recorded questionnaire
Provider checks fetal presentation by palpation of abdomen. (binary)
Time frame: up to 6 months after installation
Initial Exam Fetal Heart Rate Assessment as measured by observer recorded questionnaire
Provider checks fetal heart rate with fetoscope/Doppler/ultrasound. (binary)
Time frame: up to 6 months after installation
Initial Exam: Vaginal Examination as measured by observer recorded questionnaire
Provider performs vaginal examination at initial exam. (binary)
Time frame: up to 6 months after installation
Sterile Gloves for All Exams as measured by observer recorded questionnaire
Provider wears sterile gloves for all vaginal examinations. (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
Support of Perineum as measured by observer recorded questionnaire
Provider supports perineum after baby's head is delivered. (binary)
Time frame: up to 6 months after installation
Cord Traction as measured by observer recorded questionnaire
Applies traction to the cord while applying suprapubic counter traction. (binary)
Time frame: up to 6 months after installation
Uterine Massage as measured by observer recorded questionnaire
Provider performs uterine massage immediately following the delivery of the placenta. (binary)
Time frame: up to 6 months after installation
Newborn Temperature as measured by observer recorded questionnaire
Provider checks newborn's temperature. (binary)
Time frame: up to 6 months after installation
Assistance with Breastfeeding as measured by observer recorded questionnaire
Provider assists mother with breastfeeding. (binary)
Time frame: up to 6 months after installation
Sterilization of Equipment as measured by observer recorded questionnaire
Provider sterilizes or uses high-level disinfection for all reusable instruments. (binary)
Time frame: up to 6 months after installation
Waste Disposal as measured by observer recorded questionnaire
Provider disposes of all contaminated waste in leak-proof containers. (binary)
Time frame: up to 6 months after installation
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)
Time frame: up to 6 months after installation
Delay in Facility Arrival as measured by observer recorded questionnaire
Time between facility arrival and first contact with health worker (mins)
Time frame: up to 6 months after installation
Delay in First Exam as measured by observer recorded questionnaire
Time between facility arrival and first assessment (mins)
Time frame: up to 6 months after installation
Delay in Uterotonic as measured by observer recorded questionnaire
Time between delivery and uterotonic (mins)
Time frame: up to 6 months after installation
Delay in Assessment for Lacerations as measured by observer recorded questionnaire
Time between delivery and assessment of perineal and vaginal lacerations (mins)
Time frame: up to 6 months after installation
Delay in Drying Newborn as measured by observer recorded questionnaire
Time between delivery and drying baby with towel (mins)
Time frame: up to 6 months after installation
Delay in Breastfeeding Initiation as measured by observer recorded questionnaire
Time between delivery and initiation of breastfeeding (mins)
Time frame: up to 6 months after installation