Maternal and Newborn HealthNCT02104635
Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya
A study testing Delivery of a Post-Partum Package in people with Maternal and Newborn Health, run by Harvard School of Public Health (HSPH) at 1 site in Kenya.
Trial summary
This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Maternal and Newborn Health
- What is being tested?
- Delivery of a Post-Partum Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteKenya
- Study dates
- Apr 2014to Oct 2014
- 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 18 to 40 years
- Women only
- Adult
Who may be able to join
- Women between 18 and 40 years old are eligible for inclusion if they have had a safe normal delivery of a live infant delivery at a Jacaranda Health facility. Eligible women must reside in a 20 km radius from the Jacaranda Health's hospital facility in peri-urban Nairobi. Women must provide a phone number to where they expect that can be reached 2 weeks postpartum.
Who cannot join
- Women who elect to leave the Jacaranda Health facility before the recommended 24 hours, against medical advice, postpartum are not eligible to participate in the postpartum care study. Women and their newborns who are referred to another hospital for higher level emergency obstetric or neonatal care will not be eligible to participate. Women who relocate outside the defined geographic area surrounding the hospital after their delivery are also not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.
- Conditions
- Maternal and Newborn Health
- Being tested
- Delivery of a Post-Partum Package
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of a Post-Partum PackageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group receives standard of care from Jacaranda clinic and does not receive any additional post-partum check-in from a community health worker. |
| CHW-Visit | Experimental | The CHW-Visit group will receive a visit at their home from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check. Receives: Behavioral: Delivery of a Post-Partum Package |
| CHW-Phone | Experimental | The CHW-Visit group will receive a phone call from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check. Receives: Behavioral: Delivery of a Post-Partum Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications detected
Any maternal complications detected Number of maternal complications detected Any newborn complications detected Number of newborn complications detected
Measured: 3 days after delivery
Successful referrals
If CHW made referral on day 3 for baby, respondent went to health facility If CHW made referral on day 3 for mother, respondent went to health facility
Measured: 10 days after delivery (survey and administrative records)
Care Seeking Behavior around complications and well baby check-up
Brought baby to health facility for a well-baby check up If maternal complications (self-reported) in past week, visited or called health facility If baby complications (self-reported) in past week, visited or called health facility
Measured: 10 days after delivery (survey)
Knowledge of danger signs
Can name any maternal danger signs for which care should be sought (at day 10) Number of maternal danger signs named for which care should be sought (at day 10). Note: if mother lists "other" danger signs not coded, these should be coded as appropriate danger signs for which care should be sought or not Can name any baby danger signs for which care should be sought (at day 10) Number of baby danger signs named for which care should be sought (at day 10). Note: if mother lists "other" danger signs not coded, these should be coded as appropriate danger signs for which care should be sought or not
Measured: 10 days after delivery (survey)
Breastfeeding
Fed only breastmilk in past week
Measured: 10 days and 9 weeks after delivery (survey)
Secondary outcomes (5)
Referrals
Any referral made for mother Any referral made for newborn
Measured: 3 days after delivery (from admin records)
Feeding behavior
Fed baby at least 3 times in past 8 hours (at 10 days) Fed baby at least 2 times in past 8 hours (at 9 weeks) No complications breastfeeding in past week (at 10 days and at 9 weeks) Applied nothing/only water to umbilical stump (at 10 days) Ate any protein (at 10 days and at 9 weeks) Mentions keeping baby warm for bath (at 10 days) Feeds baby at night (at 10 days) Using any family planning method (at 9 weeks)
Measured: 10 days 9 week after delivery (survey)
Care seeking regarding breastfeeding, vaccines and child wellness
If had complication breastfeeding, visited or called health facility (at day 10) Baby has had first vaccine course in a timely manner, should be at 6 weeks according to Kenyan recommendations (measured at 9 weeks) Baby was brought in for child wellness check up (measured at 9 weeks)
Measured: 10 days and 9 weeks after delivery (survey)
Knowledge of feeding and safety
Mentions feeding at least 3 times in 8 hours Knows two types of protein mother can eat Knows to keep baby warm while bathing Knows to feed baby at night Knows to keep cord clean and dry to prevent infection Knows to wash hands after going to toilet Knows to wash hands before touching/holding baby Knows to wash hands after changing diaper
Measured: 10 days after delivery (survey)
Care seeking at Jacaranda Health
Brought baby to JH within 10 days of delivery for any reason Mother came to JH within 10 days of delivery for any reason Brought baby to JH within 10 days of delivery for well-baby visit
Measured: 10 days after delivery (survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal and Newborn HealthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Jessica Cohen, Harvard School of Public Health, Saving Lives at Birth Initiative, Jacaranda Health
- Responsible party
- Principal investigator, Margaret McConnell, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104635
- Sponsor's protocol ID
- Saving Lives at Birth
- Status last verified
- Dec 2014
- First submitted
- 2 Apr 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McConnell M, Ettenger A, Rothschild CW, Muigai F, Cohen J. Can a community health worker administered postnatal checklist increase health-seeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya. BMC Pregnancy Childbirth. 2016 Jun 4;16(1):136. doi: 10.1186/s12884-016-0914-z.
PubMed 27260500
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya
- ClinicalTrials.gov ID
- NCT02104635
- Acronym / sponsor ID
- Saving Lives at Birth
- Conditions
- Maternal and Newborn Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Jessica Cohen, Harvard School of Public Health, Saving Lives at Birth Initiative, Jacaranda Health
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group receives standard of care from Jacaranda clinic and does not receive any additional post-partum check-in from a community health worker. |
| CHW-Visit | Experimental | Behavioral: Delivery of a Post-Partum PackageThe CHW-Visit group will receive a visit at their home from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check. |
| CHW-Phone | Experimental | Behavioral: Delivery of a Post-Partum PackageThe CHW-Visit group will receive a phone call from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women between 18 and 40 years old are eligible for inclusion if they have had a safe normal delivery of a live infant delivery at a Jacaranda Health facility. Eligible women must reside in a 20 km radius from the Jacaranda Health's hospital facility in peri-urban Nairobi. Women must provide a phone number to where they expect that can be reached 2 weeks postpartum.
Key exclusion criteria (1 listed)
- Women who elect to leave the Jacaranda Health facility before the recommended 24 hours, against medical advice, postpartum are not eligible to participate in the postpartum care study. Women and their newborns who are referred to another hospital for higher level emergency obstetric or neonatal care will not be eligible to participate. Women who relocate outside the defined geographic area surrounding the hospital after their delivery are also not eligible.
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 |
|---|---|---|
| Delivery of a Post-Partum Package | Behavioural | CHW-Phone, CHW-Visit |
Primary outcome
Complications detected
Time frame: 3 days after delivery
Any maternal complications detected Number of maternal complications detected Any newborn complications detected Number of newborn complications detected
Successful referrals
Time frame: 10 days after delivery (survey and administrative records)
If CHW made referral on day 3 for baby, respondent went to health facility If CHW made referral on day 3 for mother, respondent went to health facility
Care Seeking Behavior around complications and well baby check-up
Time frame: 10 days after delivery (survey)
Brought baby to health facility for a well-baby check up If maternal complications (self-reported) in past week, visited or called health facility If baby complications (self-reported) in past week, visited or called health facility
Knowledge of danger signs
Time frame: 10 days after delivery (survey)
Can name any maternal danger signs for which care should be sought (at day 10) Number of maternal danger signs named for which care should be sought (at day 10). Note: if mother lists "other" danger signs not coded, these should be coded as appropriate danger signs for which care should be sought or not Can name any baby danger signs for which care should be sought (at day 10) Number of baby danger signs named for which care should be sought (at day 10). Note: if mother lists "other" danger signs not coded, these should be coded as appropriate danger signs for which care should be sought or not
Breastfeeding
Time frame: 10 days and 9 weeks after delivery (survey)
Fed only breastmilk in past week
5 secondary outcomes
Referrals
Time frame: 3 days after delivery (from admin records)
Feeding behavior
Time frame: 10 days 9 week after delivery (survey)
Care seeking regarding breastfeeding, vaccines and child wellness
Time frame: 10 days and 9 weeks after delivery (survey)
Knowledge of feeding and safety
Time frame: 10 days after delivery (survey)
Care seeking at Jacaranda Health
Time frame: 10 days after delivery (survey)
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 2 Dec 2014.
- Derived from this study: PubMed 27260500McConnell M, Ettenger A, Rothschild CW, Muigai F, Cohen J. Can a community health worker administered postnatal checklist increase health-seeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya. BMC Pregnancy Childbirth. 2016 Jun 4;16(1):136. doi: 10.1186/s12884-016-0914-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of a Post-Partum Package in people with Maternal and Newborn Health, 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 1 inclusion and 1 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 2 Dec 2014. 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?
Complications detected (time frame: 3 days after delivery). The study lists 5 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 NCT02104635, which also lists 1 linked publication.
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 2 Dec 2014.