NCT03589625

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

June 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

June 7, 2018

Last Update Submit

July 10, 2020

Conditions

Keywords

electricity and healthmaternal healthquality of caresolar power

Outcome Measures

Primary Outcomes (8)

  • 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

    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.

    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.

    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.

    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.

    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.

    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

    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.

    up to 6 months after installation

Secondary Outcomes (72)

  • Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire

    up to 6 months after installation

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

    up to 6 months after installation

  • Consistent satisfactory light source as measured by observer recorded questionnaire

    up to 6 months after installation

  • Fetal Doppler Use as measured by observer recorded questionnaire

    up to 6 months after installation

  • Phone availability as measured by observer recorded questionnaire

    up to 6 months after installation

  • +67 more secondary outcomes

Study Arms (2)

Solar Suitcase Installation First Group

EXPERIMENTAL

Facilities will receive the installation of the Solar Suitcase shortly after baseline data collection.

Other: Solar Suitcase

Solar Suitcase Installation Second Group

EXPERIMENTAL

Facilities will act as a comparator for experimental group 1 and then will receive the installation of the Solar Suitcase shortly after midline data collection.

Other: Solar Suitcase

Interventions

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.

Solar Suitcase Installation First GroupSolar Suitcase Installation Second Group

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women who are admitted for labor and delivery at participating facilities.
  • Women aged 16 years or older.

You may not qualify if:

  • 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
  • Health worker objects to the observation.
  • For eligibility of health facility:
  • 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).
  • facility already has a Solar Suitcase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Kampala, Uganda

Location

Related Publications (4)

  • 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.

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

    BACKGROUND
  • 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.

  • 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.

Study Officials

  • Jessica Cohen, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Slawa Rokicki, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Stepped-wedge cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Global Health

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 18, 2018

Study Start

June 13, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations