Effect of telephone-based postnatal care on the health of mothers and their newborns
ISRCTN | ISRCTN46905855 |
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DOI | https://doi.org/10.1186/ISRCTN46905855 |
ClinicalTrials.gov number | Nil Known |
Secondary identifying numbers | GHS-ERC003/06/20 |
- Submission date
- 22/03/2021
- Registration date
- 09/04/2021
- Last edited
- 31/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The postnatal period (period starting from delivery of the baby up to six weeks after delivery) is a very critical period for newly delivered mothers and their babies. This is because it provides an opportunity for identifying and correcting complications that easily result in the illness or death of both mother and baby. However, it is one of the areas of mother and child health programs that receive little attention. Counselling for mothers before they are discharged from health facilities is usually done in groups and mothers are unable to get their individual concerns addressed. Some mothers are also discharged from the health facilities too early and given counselling at a time when they are either too exhausted or distracted to pay attention. As a result, very little information from the counselling is retained. Some mothers also face challenges at home regarding care for their babies and their own health. Some also lack the necessary support to resist pressure from families and friends who impose harmful traditional postnatal care practices. These challenges require providing mothers with easy access to a health worker to help improve mother and baby’s health and adopt healthy postnatal practices. In order to achieve this, the researchers are taking advantage of the wide availability of mobile telephone to counsel and maintain contact with mothers throughout the postnatal period and measure how it changes health outcomes in the mothers and their babies. The researchers want to test a new method of postnatal care. This method includes in addition to the usual postnatal care, making telephone calls to mothers to reinforce the postnatal counselling message a few hours after they reach their various homes after discharge from the hospital, as well as providing them with a dedicated telephone number of a health worker whom they can reach out to anytime to address their concerns in the first six weeks after delivery. They want to test how this new method will be different from the usual postnatal care received by mothers and their newborn babies at the health facilities.
Who can participate?
Newly delivered mothers aged 18 years and above and their newborn babies delivered at the two participating hospitals who have been discharged from the hospital but has not left the hospital, are not too ill to participate in this study and are likely to stay in the Greater Accra Region for at least three months after delivery. The mothers and their babies should not be participating in any other intervention and the mothers should be willing to participate in the study.
What does the study involve?
The study involves comparing telephone-based postnatal follow-up in addition to usual postnatal care with the usual postnatal care given by hospitals. Participants are randomly allocated to either of two groups (with each participant having an equal chance of being in either group). Participants and researchers do not have a choice in the group to which they are assigned. Participants in the first group will receive in addition to the usual postnatal care, telephone-based postnatal follow up by receiving phone call from a health worker within two days after discharge from the hospital. They will also be given telephone contact of a health worker who they would call for support in clarifying and given guidance on any concerns they might have for a period of six weeks after delivery. The participants in the second group will receive the usual postnatal care given by the hospital. Mother-baby pairs are assessed by the research team and have passed the initial assessment. They are then randomly assigned to either of the two groups of the study. Mothers are asked to answer questions about themselves, their family, pregnancy and delivery. Mother-baby pairs in the first group of the study are then called within 48 hours after leaving the hospital and counselled on their own care and care of their newborns using a standard guideline. They are given the opportunity to ask questions for clarification. They are then given the telephone number of the health worker, who is available to support them with the appropriate care should they have any concerns relating to their own health or that of their babies for the first six weeks after delivery. After three months of follow-up, the mothers in both groups are interviewed on their health, their babies’ health and breastfeeding, postanal clinic attendance and family planning practices. The study is expected to last for seven months.
What are the possible benefits and risks of participating?
Participants may benefit directly from this study as a result of the children and their mothers being followed up by health workers and referred to appropriate health facilities when ill. Also, the findings from the study are expected to benefit mothers and their babies because they are likely to improve maternal and infant health outcomes. The Family Health Division of the Ghana Health Service may also use the results in planning postnatal care programs for mothers and their babies. The research by itself will not pose any major risks to the participants. However, there is a potential minor risk of some questions creating discomfort to participants. The research assistants are well trained to ask the questions in a humane manner so as to minimize this risk. Participants also have the right not to answer any question or discontinue the interview without attracting any penalty.
Where is the study run from?
Two major hospitals in the Greater Accra Region of Ghana are taking part in this study. These are Tema General Hospital in the Tema Metropolis and Greater Accra Regional Hospital in Accra Metropolis
When is the study starting and how long is it expected to run for?
January 2020 to April 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Donne Kofi Ameme (Principal Investigator)
amemedonne@yahoo.com
2. Dr Ernest Kenu
ekenu@ug.edu.gh
Contact information
Scientific
University of Ghana School of Public Health
P.O Box LG 13
Legon
Accra
GH13
Ghana
0000-0002-1017-7155 | |
Phone | +233 (0)208233513 |
dkameme@st.ug.edu.gh |
Study information
Study design | Interventional open label randomized controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Effect of telephone-based postnatal follow-up on infant and maternal health outcomes in Accra and Tema metropolises: a randomised controlled trial |
Study objectives | Mother-baby pairs followed up by a combination of telephone-based postnatal health education and routine health facility based postnatal care have better maternal and infant health outcomes than those followed up with routine health facility-based postnatal care alone |
Ethics approval(s) | Approved 21/08/2020, Ghana Health Service Ethics Review Committee (Research & Development Division, Ghana Health Service, P.O.Box MB190, Accra, Ghana; +233-0302-960628; ethics.research@ghsmail.org), ref: GHS-ERC003/06/20 |
Health condition(s) or problem(s) studied | Improving the general health of nursing mothers and their newborns |
Intervention | Mother-baby pairs are randomised into either of two arms of postnatal follow-up interventions: 1. Telephone-based follow up in addition to routine health facility based follow up; and 2. Routine health facility based follow up alone. Intervention will be a telephone-based follow up in two parts: Part 1: Mothers are called within 48 hours after discharge and provided with counselling on care of the baby including infant feeding, how to keep baby warm and addressing family challenges. Part 2. Mother is given telephone access to a midwife on-call during the first six weeks after delivery (postnatal period) to ask questions about their own or babies’ health and care, when the need arise. The mother-baby pairs in both arms were followed up after discharge till three months after delivery. Mother-singleton baby pairs in the intervention arm were followed up via telephone call in addition to hospital’s routine follow up while those in the control arm had only the routine health facility based postnatal care. Data was collected on maternal, fetal and newborn characteristics at baseline, and on infant and maternal health outcomes within three months of follow up. |
Intervention type | Behavioural |
Primary outcome measure | Mothers' self report of: 1. Infant illness episode (acute illness episode for which help was sought) episodes within first three months of life measured three months after delivery 2. Maternal illness (acute illness for which help was sought) within first three months of postnatal period measured three months after delivery |
Secondary outcome measures | Mothers' self report of: 1. Exclusive breastfeeding at three months of age 2. Maternal family planning use within the first three months of postnatal period measured at three months after delivery 3. Maternal post-partum depression at three months after delivery 4. Postnatal clinic attendance at 7-14 days and 6 weeks |
Overall study start date | 03/01/2020 |
Completion date | 30/04/2021 |
Eligibility
Participant type(s) | Mixed |
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Age group | Mixed |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 400 |
Total final enrolment | 400 |
Key inclusion criteria | 1. Mother should be at least 18 years of age and have access to a functional mobile phone 2. Mother and baby should be discharged from hospital but not have left the hospital 3. Babies and their parents should not be participating in another intervention 4. Mother-baby pairs who do not intend to move out of the Greater Accra Region within three months after delivery 5. Mother should be willing to consent to participate in the study |
Key exclusion criteria | 1. Babies born with severe congenital anomaly that require major medical and or surgical intervention 2. Babies born preterm 3. Babies admitted to NICU for severe illness after delivery 4. Either or both parents being a health worker |
Date of first enrolment | 15/09/2020 |
Date of final enrolment | 30/12/2020 |
Locations
Countries of recruitment
- Ghana
Study participating centres
Accra
GH
Ghana
Tema
GH
Ghana
Sponsor information
University/education
School of Public Health
P.O.Box LG 13
Legon
Accra
GH13
Ghana
Phone | +233 (0)303-966406 |
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sph@ug.edu.gh | |
Website | https://publichealth.ug.edu.gh |
https://ror.org/01r22mr83 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 31/03/2022 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | Planned dissemination of the results of this trial in: 1. Thesis report 2. High impact peer-reviewed journals 3. Conference presentations 4. Policy makers at the Ghana Health Service |
IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 29/10/2022 | 31/10/2022 | Yes | No |
Editorial Notes
31/10/2022: Publication reference added.
12/04/2021: The overall trial end date has been changed from 31/03/2021 to 30/04/2021 and the plain English summary has been updated accordingly.
09/04/2021: Trial's existence confirmed by Ghana Health Service Ethics Review Committee