Quality of CareNCT05110521
Evaluation of a Nurse Mentorship and Digital Health Package Intervention in Kenya
A study testing PROMPTS and MENTORS in people with Quality of Care, run by Harvard School of Public Health (HSPH) at 1 site in Kenya.
Trial summary
The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Care
- What is being tested?
- PROMPTS and MENTORS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,992 participants
- Where
- 1 siteKenya
- Study dates
- 5 Nov 2021to 26 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- have at least 50 normal vaginal deliveries per month on average
- have at most 400 normal vaginal deliveries per month on average
- are owned by the government or a faith-based organization
- have no potentially confounding ongoing research or quality-improvement programs at the time of selection (especially mentorship or mHealth programs).
- nurses or midwives
- provide delivery care in the study facility
Show all 16Show fewer
- have no plan to move to a different facility in the next 6 months (baseline only).
- at least 15 years old
- have access to a mobile phone
- are at least 16 weeks pregnant or in Month 5, 6, 7, 8, and 9 of pregnancy.
- Inclusion Criteria for Participants of Delivery Observations:
- at least 15 years old
- are admitted for labor and delivery at the maternity ward
- Exclusion Criteria for Participants of Delivery Observations:
- are presenting for conditions other than labor and delivery (e.g., patients admitted for prenatal observation or complications from abortion)
- are immediately transferred to another hospital.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial
The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes. This package intervention includes two programs: PROMPTS, a digital health platform for mothers aimed to improve knowledge and health behaviors and increase care-seeking behavior at the right time and place, and MENTORS, a facility-based program aimed to increase and sustain providers' knowledge and skills in basic and emergency obstetric and newborn care. Facilities will be randomized into a treatment group that receives the package or a control group that receives usual care. Patient outcomes include health knowledge, health behaviors and health care utilization in the prenatal and postnatal period; provider outcomes include knowledge and quality of care.
Read the detailed description
This study is designed as a parallel arm cluster randomized controlled trial (RCT). Randomization of the intervention package will occur at the facility level. The investigators will randomize 40 facilities across 8 counties into either the intervention or control group.
Data will be collected at multiple points during the study period. Facility baseline data collection will occur over a one month period in each facility. Baseline data collection will include a facility assessment, maternity register data extraction and health worker interviews.
In order to evaluate the PROMPTS component of the intervention, the investigators will enroll a cohort of women during baseline facility data collection that will be followed through their pregnancy, delivery and postpartum period. The investigators will recruit pregnant women attending study clinics for antenatal care during the baseline data collection period. They will be surveyed by phone twice in the follow-up period: once in the last month of pregnancy and again at 7- to 8-weeks postpartum. Women enrolled from the intervention facilities will be offered the PROMPTS intervention immediately after the baseline survey.
The facility-based endline data collection will occur 4-5 months after the end of baseline and will last for 1-2 months in each facility. The facility-based endline data collection will include register data extraction, health worker interviews, and observations of quality of care during labor and delivery.
A process evaluation will be conducted using administrative program data collected by Jacaranda Health to monitor intervention implementation within the treatment facilities.
After the endline, facilities in the control group will also be offered the intervention.
- Conditions
- Quality of Care
- Being tested
- PROMPTS, MENTORS
- Keywords
- maternal and newborn health, quality of care, mentorship, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMPTSBehavioural
PROMPTS is a two-way Short Message Service (SMS) digital health platform that connects mothers with information, advice and referrals to care during the prenatal and postnatal period. The platform also collects information from women on care experience that is reported back to maternity facilities.
MENTORSBehavioural
MENTORS is a program in which in facility nurse-mentors are trained and supported to offer training to nurses, midwives and other maternity facility staff on aspects of basic and emergency obstetric and newborn care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (PROMPTS and MENTORS offered) | Experimental | Health facilities randomized into the Intervention Arm will be offered the MENTORS program, which trains in-facility nurse-mentors to provide health workers with training and mentorship on aspects of basic and emergency obstetric and newborn care. At health facilities in the intervention arm, patients attending antenatal care clinics will be offered the PROMPTS program, which is a digital health platform that connects mothers with information, advice and referrals to care. Receives: Behavioral: PROMPTS; Behavioral: MENTORS |
| Control (Routine Care/No PROMPTS or MENTORS OFFERED) | No intervention | In the control arm, neither the PROMPTS program nor the MENTORS program will be offered during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of routine maternity care, measured by delivery observation
A ratio based on a 20-item index that measures essential actions providers must perform during the course of labor and delivery (Tripathi et al., 2015). The total score is calculated as the fraction of 20 items weighted equally, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.
Measured: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Provider knowledge on obstetric and newborn care, measured by provider survey
A continuous variable based on the answers to 10 questions on normal labor, infection prevention and control, preeclampsia and eclampsia, newborn care, postpartum hemorrhage, and shoulder dystocia.
Measured: assessed approximately 6 months after intervention initiation
Patient knowledge on danger signs, measured by patient survey
A ratio based on questions that ask whether a respondent would seek medical care immediately in response to serious prenatal, neonatal, and postpartum danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital/call a doctor or not in response to a serious health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.
Measured: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
Care seeking in response to severe danger signs, measured by patient survey
A binary variable based on a series of questions that measure whether a respondent sought any medical advice or treatment for a healthcare provider in response to severe prenatal, postnatal, and neonatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
Measured: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
Postnatal care for mom within six weeks postpartum, measured by patient survey
a binary variable equal to 1 if there was at least 1 postnatal visit within six weeks postpartum AND mom's own health was discussed during the postnatal care visit
Measured: assessed at 7 - 8 weeks postpartum
Number of antenatal care visits, measured by patient survey
a continuous variable for the total number of antenatal care visits during the entire pregnancy
Measured: assessed between 7 - 8 weeks postpartum
Quality of care for management of neonatal resuscitation, measured by simulation exercise
A continuous variable based on providers' actions in a simulation exercise for neonatal resuscitation. Each question is scored according to whether a provider performs the correct step for neonatal resuscitation. The total score is calculated as the sum of all questions. Higher scores mean a better outcome.
Measured: assessed approximately 6 months after intervention initiation
Secondary outcomes (28)
Quality of care for management of maternal and neonatal complications, measured by delivery observation
A continuous variable based on essential actions providers should perform to manage maternal and neonatal complications, including postpartum hemorrhage, pre-eclampsia/eclampsia, neonatal resuscitation, and shoulder dystocia. Score is calculated as the fraction of total items applicable to each case. The total score has a range of 0 to 1, with higher scores indicating better quality of care.
Measured: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Quality of care for infection prevention, measured by delivery observation
A continuous variable based on a series of questions that measure whether infection prevention and control procedures are performed during labor and delivery. Individual item is assigned a score equal to 1 if an action is done.
Measured: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Quality of care for partograph completion, measured by delivery observation
A continuous variable based on a series of questions that measure whether progress of labor is plotted appropriately on the partograph. Individual item is assigned a score equal to 1 if an action is done.
Measured: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Provider motivation and satisfaction, measured by provider survey
A continuous variable based on 11 questions that measure health workers' motivation adapted from a scale validated in Kenya (Mbindyo et al, 2009). Individual questions are scored using a 1-to-5 LIkert scale. The total score is calculated as the sum of all items (with a few items reverse coded).
Measured: assessed approximately 6 months after intervention initiation
Patient treatment during labor and delivery, measured by delivery observation
A continuous variable based on a series of questions that measure aspects of mistreatment during labor and delivery: interpersonal abuse scale, exams \& procedures index, and unsupportive birth environment (Berger et al., 2021). Individual items are scored to 1 if observed.
Measured: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Respectful maternity care during last antenatal care visit, measured by patient survey
A binary variable equal to one if a patient felt she was treated with respect during her last antenatal care visit.
Measured: assessed between 36 - 42 weeks' gestation
Disrespect in care during delivery, measured by patient survey
An ordinal variable based on to what extent a patient was abused or treated in a way that made her feel humiliated/disrespected during her delivery.
Measured: assessed between 7 - 8 weeks postpartum
Severe morbidity and mortality, measured by delivery observation and document review
A composite binary variable that measures whether a woman or her baby had any severe maternal complication (including severe postpartum hemorrhage, severe pre-eclampsia, eclampsia, severe systemic infection or sepsis, and uterine rupture), neonatal complication (including asphyxia), maternal mortality, and perinatal mortality (including stillbirth and newborn death). The value of this outcome will be 1 if a woman or her baby had at least one complication listed or died.
Measured: assessed at approximately 6 months after intervention initiation
Medical advice/treatment seeking during pregnancy, measured by patient survey
A binary variable that measures whether a participant sought advice or treatment from a healthcare professional in the past month
Measured: assessed between 36 - 42 weeks' gestation
Medical advice/treatment seeking for baby's health postpartum, measured by patient survey
A binary variable that measures whether a participant sought advice or treatment from a healthcare professional since she left the hospital after delivery for her baby's health
Measured: assessed between 7 - 8 weeks postpartum
Medical advice/treatment seeking for mom's health postpartum, measured by patient survey
A binary variable that measures whether a participant sought advice or treatment from a healthcare professional since she left the hospital after delivery for her own health
Measured: assessed between 7 - 8 weeks postpartum
Care seeking in response to severe antenatal danger signs, measured by patient survey
A binary variable based on a series of questions that measure whether a respondent sought any medical advice or treatment for a healthcare provider in response to severe prenatal danger signs.The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
Measured: assessed between 36 - 42 weeks' gestation
Care seeking in response to severe postnatal danger signs, measured by patient survey
A binary variable based on a series of questions that measure whether a respondent sought any medical advice or treatment for a healthcare provider in response to severe postnatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
Measured: assessed between 7 - 8 weeks postpartum
Care seeking in response to severe neonatal danger signs, measured by patient survey
A binary variable based on a series of questions that measure whether a respondent sought any medical advice or treatment for a healthcare provider in response to severe neonatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
Measured: assessed between 7 - 8 weeks postpartum
Patient knowledge on prenatal danger signs, measured by patient survey
A ratio based on questions that ask whether a respondent would seek medical care immediately in response to serious prenatal danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital or not in response to a health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately..
Measured: assessed between 36 - 42 weeks' gestation
Patient knowledge on postnatal danger signs, measured by patient survey
A ratio based on questions that ask whether a respondent would seek medical care immediately in response to serious postpartum danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital or not in response to a health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.
Measured: assessed between 7 - 8 weeks postpartum
Patient knowledge on neonatal danger signs, measured by patient survey
A ratio based on questions that ask whether a respondent would seek medical care immediately in response to serious neonatal danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital or not in response to a health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.
Measured: assessed between 7 - 8 weeks postpartum
Patient knowledge on signs of labor, measured by patient survey
A count variable that measures the number of signs of labor a woman lists without being prompted.
Measured: assessed between 36 - 42 weeks' gestation
Patient knowledge on breastfeeding, measured by patient survey
A binary variable that measures whether a woman correctly identifies the best time to start breastfeeding after delivery
Measured: assessed between 36 - 42 weeks' gestation
Use of prenatal supplements, measured by patient survey
a binary variable that measures whether a woman is taking iron and folic acid supplementation tablets or prenatal supplement that contains iron and folic during her pregnancy
Measured: assessed between 36 - 42 weeks' gestation
Birth preparation, measured by patient survey
a count variable that measures the total number of things a woman has done to prepare for her delivery
Measured: assessed between 36 - 42 weeks' gestation
Institutional delivery, measured by patient survey
a binary variable that measures whether a woman delivered her baby in a hospital or health clinic/center
Measured: assessed between 7 - 8 weeks postpartum
Exclusive breastfeeding, measured by patient survey
a binary variable that measures whether a baby is exclusively fed with breast milk
Measured: assessed between 7 - 8 weeks postpartum
Sleep safety, measured by patient survey
A binary variable that measures weather a woman puts her baby to sleep in the safest position at night
Measured: assessed between 7- to 8-week postpartum
Interaction with newborn, measured by patient survey
A binary variable that measures weather a woman spoke or sang to the baby in the past 24 hours
Measured: assessed between 7- to 8-week postpartum
Patient self-efficacy in care-seeking during last antenatal care visit, measured by patient survey
a binary variable that measures whether a woman feels that she could ask healthcare workers at her last antenatal care visit any question she had about her pregnancy.
Measured: assessed between 36 - 42 weeks' gestation
Patient self-efficacy in care-seeking during pregnancy and delivery, measured by patient survey
an ordinal variable that measures to what extent a woman feels she can get her questions about her health answered during pregnancy and delivery.
Measured: assessed between 7- to 8-week postpartum
Timeliness of care, measured by delivery observation
A continuous variable indicating delays in essential actions providers should perform, including time between facility arrival and first contact with health care worker, time between delivery and provision of uterotonic, time between delivery and breastfeeding initiation, and time between delivery and first maternal exam after birth.
Measured: assessed from patient arrival to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start5 Nov 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Quality of CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action, Jacaranda Health
- Responsible party
- Principal investigator, Jessica Cohen, Harvard School of Public Health (HSPH)
- Investigators
- Jessica L Cohen, PhD, Principal investigator, Harvard School of Public Health (HSPH)Margaret A McConnell, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110521
- Sponsor's protocol ID
- IRB21-1013
- Status last verified
- Aug 2022
- First submitted
- 25 Oct 2021
- Last updated
- 31 Aug 2022
- 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 26107655Mbindyo PM, Blaauw D, Gilson L, English M. Developing a tool to measure health worker motivation in district hospitals in Kenya. Hum Resour Health. 2009 May 20;7:40. doi: 10.1186/1478-4491-7-40.
PubMed 19457237Berger BO, Strobino DM, Mehrtash H, Bohren MA, Adu-Bonsaffoh K, Leslie HH, Irinyenikan TA, Maung TM, Balde MD, Tuncalp O. Development of measures for assessing mistreatment of women during facility-based childbirth based on labour observations. BMJ Glob Health. 2021 Aug;5(Suppl 2):e004080. doi: 10.1136/bmjgh-2020-004080.
PubMed 34362791Zhang L, Vatsa R, Chang W, Akinyi S, Little S, Gakii C, Mungai J, Kahumbura C, Rajasekharan S, Wickramanayake A, McConnell M, Cohen J. Impact of a long-term mentorship program for childbirth providers on quality of care: A cluster randomized controlled trial. PLOS Glob Public Health. 2026 Sep 2;6(9):e0006073. doi: 10.1371/journal.pgph.0006073. eCollection 2026.
PubMed 42685042Vatsa R, Chang W, Akinyi S, Little S, Gakii C, Mungai J, Kahumbura C, Wickramanayake A, Rajasekharan S, Cohen J, McConnell M. Impact evaluation of a digital health platform empowering Kenyan women across the pregnancy-postpartum care continuum: A cluster randomized controlled trial. PLoS Med. 2025 Feb 3;22(2):e1004527. doi: 10.1371/journal.pmed.1004527. eCollection 2025 Feb.
PubMed 39899612
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05110521
- Acronym / sponsor ID
- IRB21-1013
- Conditions
- Quality of Care
- Keywords
- maternal and newborn health, quality of care, mentorship, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,992 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Innovations for Poverty Action, Jacaranda Health
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- 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.
The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes. This package intervention includes two programs: PROMPTS, a digital health platform for mothers aimed to improve knowledge and health behaviors and increase care-seeking behavior at the right time and place, and MENTORS, a facility-based program aimed to increase and sustain providers' knowledge and skills in basic and emergency obstetric and newborn care. Facilities will be randomized into a treatment group that receives the package or a control group that receives usual care. Patient outcomes include health knowledge, health behaviors and health care utilization in the prenatal and postnatal period; provider outcomes include knowledge and quality of care.
Detailed description
This study is designed as a parallel arm cluster randomized controlled trial (RCT). Randomization of the intervention package will occur at the facility level. The investigators will randomize 40 facilities across 8 counties into either the intervention or control group.
Data will be collected at multiple points during the study period. Facility baseline data collection will occur over a one month period in each facility. Baseline data collection will include a facility assessment, maternity register data extraction and health worker interviews.
In order to evaluate the PROMPTS component of the intervention, the investigators will enroll a cohort of women during baseline facility data collection that will be followed through their pregnancy, delivery and postpartum period. The investigators will recruit pregnant women attending study clinics for antenatal care during the baseline data collection period. They will be surveyed by phone twice in the follow-up period: once in the last month of pregnancy and again at 7- to 8-weeks postpartum. Women enrolled from the intervention facilities will be offered the PROMPTS intervention immediately after the baseline survey.
The facility-based endline data collection will occur 4-5 months after the end of baseline and will last for 1-2 months in each facility. The facility-based endline data collection will include register data extraction, health worker interviews, and observations of quality of care during labor and delivery.
A process evaluation will be conducted using administrative program data collected by Jacaranda Health to monitor intervention implementation within the treatment facilities.
After the endline, facilities in the control group will also be offered the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (PROMPTS and MENTORS offered) | Experimental | Behavioral: PROMPTS, Behavioral: MENTORSHealth facilities randomized into the Intervention Arm will be offered the MENTORS program, which trains in-facility nurse-mentors to provide health workers with training and mentorship on aspects of basic and emergency obstetric and newborn care. At health facilities in the intervention arm, patients attending antenatal care clinics will be offered the PROMPTS program, which is a digital health platform that connects mothers with information, advice and referrals to care. |
| Control (Routine Care/No PROMPTS or MENTORS OFFERED) | No intervention | –In the control arm, neither the PROMPTS program nor the MENTORS program will be offered during the study period. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- have at least 50 normal vaginal deliveries per month on average
- have at most 400 normal vaginal deliveries per month on average
- are owned by the government or a faith-based organization
- have no potentially confounding ongoing research or quality-improvement programs at the time of selection (especially mentorship or mHealth programs).
- nurses or midwives
Key exclusion criteria (0 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 |
|---|---|---|
| PROMPTSPROMPTS is a two-way Short Message Service (SMS) digital health platform that connects mothers with information, advice and referrals to care during the prenatal and postnatal period. The platform also collects information from women on care experience that is reported back to maternity facilities. | Behavioural | Intervention (PROMPTS and MENTORS offered) |
| MENTORSMENTORS is a program in which in facility nurse-mentors are trained and supported to offer training to nurses, midwives and other maternity facility staff on aspects of basic and emergency obstetric and newborn care. | Behavioural | Intervention (PROMPTS and MENTORS offered) |
Primary outcome
Quality of routine maternity care, measured by delivery observation
Time frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
A ratio based on a 20-item index that measures essential actions providers must perform during the course of labor and delivery (Tripathi et al., 2015). The total score is calculated as the fraction of 20 items weighted equally, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.
Provider knowledge on obstetric and newborn care, measured by provider survey
Time frame: assessed approximately 6 months after intervention initiation
A continuous variable based on the answers to 10 questions on normal labor, infection prevention and control, preeclampsia and eclampsia, newborn care, postpartum hemorrhage, and shoulder dystocia.
Patient knowledge on danger signs, measured by patient survey
Time frame: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
A ratio based on questions that ask whether a respondent would seek medical care immediately in response to serious prenatal, neonatal, and postpartum danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital/call a doctor or not in response to a serious health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.
Care seeking in response to severe danger signs, measured by patient survey
Time frame: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
A binary variable based on a series of questions that measure whether a respondent sought any medical advice or treatment for a healthcare provider in response to severe prenatal, postnatal, and neonatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
Postnatal care for mom within six weeks postpartum, measured by patient survey
Time frame: assessed at 7 - 8 weeks postpartum
a binary variable equal to 1 if there was at least 1 postnatal visit within six weeks postpartum AND mom's own health was discussed during the postnatal care visit
Number of antenatal care visits, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
a continuous variable for the total number of antenatal care visits during the entire pregnancy
Quality of care for management of neonatal resuscitation, measured by simulation exercise
Time frame: assessed approximately 6 months after intervention initiation
A continuous variable based on providers' actions in a simulation exercise for neonatal resuscitation. Each question is scored according to whether a provider performs the correct step for neonatal resuscitation. The total score is calculated as the sum of all questions. Higher scores mean a better outcome.
28 secondary outcomes
Quality of care for management of maternal and neonatal complications, measured by delivery observation
Time frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Quality of care for infection prevention, measured by delivery observation
Time frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Quality of care for partograph completion, measured by delivery observation
Time frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Provider motivation and satisfaction, measured by provider survey
Time frame: assessed approximately 6 months after intervention initiation
Patient treatment during labor and delivery, measured by delivery observation
Time frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Respectful maternity care during last antenatal care visit, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Disrespect in care during delivery, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Severe morbidity and mortality, measured by delivery observation and document review
Time frame: assessed at approximately 6 months after intervention initiation
Medical advice/treatment seeking during pregnancy, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Medical advice/treatment seeking for baby's health postpartum, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Medical advice/treatment seeking for mom's health postpartum, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Care seeking in response to severe antenatal danger signs, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Care seeking in response to severe postnatal danger signs, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Care seeking in response to severe neonatal danger signs, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Patient knowledge on prenatal danger signs, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Patient knowledge on postnatal danger signs, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Patient knowledge on neonatal danger signs, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Patient knowledge on signs of labor, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Patient knowledge on breastfeeding, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Use of prenatal supplements, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Birth preparation, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Institutional delivery, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Exclusive breastfeeding, measured by patient survey
Time frame: assessed between 7 - 8 weeks postpartum
Sleep safety, measured by patient survey
Time frame: assessed between 7- to 8-week postpartum
Interaction with newborn, measured by patient survey
Time frame: assessed between 7- to 8-week postpartum
Patient self-efficacy in care-seeking during last antenatal care visit, measured by patient survey
Time frame: assessed between 36 - 42 weeks' gestation
Patient self-efficacy in care-seeking during pregnancy and delivery, measured by patient survey
Time frame: assessed between 7- to 8-week postpartum
Timeliness of care, measured by delivery observation
Time frame: assessed from patient arrival to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
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 31 Aug 2022.
- Background: PubMed 26107655Tripathi 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.
- Background: PubMed 19457237Mbindyo PM, Blaauw D, Gilson L, English M. Developing a tool to measure health worker motivation in district hospitals in Kenya. Hum Resour Health. 2009 May 20;7:40. doi: 10.1186/1478-4491-7-40.
- Background: PubMed 34362791Berger BO, Strobino DM, Mehrtash H, Bohren MA, Adu-Bonsaffoh K, Leslie HH, Irinyenikan TA, Maung TM, Balde MD, Tuncalp O. Development of measures for assessing mistreatment of women during facility-based childbirth based on labour observations. BMJ Glob Health. 2021 Aug;5(Suppl 2):e004080. doi: 10.1136/bmjgh-2020-004080.
- Derived from this study: PubMed 42685042Zhang L, Vatsa R, Chang W, Akinyi S, Little S, Gakii C, Mungai J, Kahumbura C, Rajasekharan S, Wickramanayake A, McConnell M, Cohen J. Impact of a long-term mentorship program for childbirth providers on quality of care: A cluster randomized controlled trial. PLOS Glob Public Health. 2026 Sep 2;6(9):e0006073. doi: 10.1371/journal.pgph.0006073. eCollection 2026.
- Derived from this study: PubMed 39899612Vatsa R, Chang W, Akinyi S, Little S, Gakii C, Mungai J, Kahumbura C, Wickramanayake A, Rajasekharan S, Cohen J, McConnell M. Impact evaluation of a digital health platform empowering Kenyan women across the pregnancy-postpartum care continuum: A cluster randomized controlled trial. PLoS Med. 2025 Feb 3;22(2):e1004527. doi: 10.1371/journal.pmed.1004527. eCollection 2025 Feb.
- Individual participant dataSharing planned: Undecided. After manuscript publication, fully de-identified data may be shared with researchers upon 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.
Jessica L Cohen, PhD principal investigator
Harvard School of Public Health (HSPH)
Margaret A McConnell, PhD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMPTS and MENTORS in people with Quality of Care, run by Harvard School of Public Health (HSPH) at 1 site in Kenya.
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 16 inclusion and 0 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 31 Aug 2022. 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 Kenya. 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?
Quality of routine maternity care, measured by delivery observation (time frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation). The study lists 7 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 NCT05110521, which also lists 5 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 31 Aug 2022.