scholarly journals Evaluation of a two-way SMS messaging strategy to reduce neonatal mortality: rationale, design and methods of the Mobile WACh NEO randomised controlled trial in Kenya

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e056062
Author(s):  
Keshet Ronen ◽  
Esther M Choo ◽  
Brenda Wandika ◽  
Jenna I Udren ◽  
Lusi Osborn ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Neonatal Mortality ◽  
Maternal Mental Health ◽  
Post Partum ◽  
Controlled Trial ◽  
Care Seeking ◽  
Essential Newborn Care ◽  
Neonatal Deaths ◽  
Live Births ◽  
Randomised Controlled

IntroductionGlobally, approximately half of the estimated 6.3 million under-5 deaths occur in the neonatal period (within the first 28 days of life). Kenya ranks among countries with the highest number of neonatal deaths, at 20 per 1000 live births. Improved identification and management of neonates with potentially life-threatening illness is critical to meet the WHO’s target of ≤12 neonatal deaths per 1000 live births by 2035. We developed an interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health (Mobile women’s and children’s health (WACh) NEO), focused on the perinatal period. Mobile WACh NEO sends automated tailored SMS messages to mothers during pregnancy and up to 6 weeks post partum. Messages employ the Information-Motivation-Behaviour Skills framework to promote (1) maternal implementation of essential newborn care (ENC, including early, exclusive breast feeding, cord care and thermal care), (2) maternal identification of neonatal danger signs and care-seeking, and (3) maternal social support and self-efficacy. Participants can also send SMS to the study nurse, enabling on-demand remote support.Methods and analysisWe describe a two-arm unblinded randomised controlled trial of the Mobile WACh NEO intervention. We will enrol 5000 pregnant women in the third trimester of pregnancy at 4 facilities in Kenya and randomise them 1:1 to receive interactive SMS or no SMS (control), and conduct follow-up visits at 2 and 6 weeks post partum. Neonatal mortality will be compared between arms as the primary outcome. Secondary outcomes include care-seeking, practice of ENC and psychosocial health. Exploratory analysis will investigate associations between maternal mental health, practice of ENC, care-seeking and SMS engagement.Ethics and disseminationThis study received ethical approval from the University of Washington (STUDY00006395), Women and Infants Hospital (1755292-1) and Kenyatta National Hospital/University of Nairobi (P310/04/2019). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences.Trial registration numberNCT04598165

scholarly journals Evaluation of a Two-Way SMS mHealth Strategy to Reduce Neonatal Mortality: Rationale, Design and Methods of a Randomized Controlled Trial in Kenya

2021 ◽  
Author(s):  
Keshet Ronen ◽  
Esther M Choo ◽  
Brenda Wandika ◽  
Jenna Udren ◽  
Lusi Osborn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neonatal Mortality ◽  
Controlled Trial ◽  
Neonatal Outcomes ◽  
Trial Registration ◽  
Care Seeking ◽  
Neonatal Deaths ◽  
Live Births ◽  
Randomized Controlled ◽  
The Impact

Abstract Background: Globally, approximately half of the estimated 6.3 million under-5 deaths occur in the neonatal period (within the first 28 days of life) and 75% of neonatal deaths occur in the first week of life. Kenya ranks among countries with the highest number of neonatal deaths, with a neonatal mortality rate of 20 per 1000 live births. Novel strategies are needed to meet the WHO’s Every Newborn Action Plan target of 10 or fewer neonatal deaths per 1000 live births by 2035. Improved identification and management of neonates with potentially life-threatening illness is critical. We developed an interactive (two-way) human-computer hybrid SMS intervention, Mobile Solutions for Neonatal Health (Mobile WACh NEO), focused on the perinatal period when risk to mothers and infants is highest. Mobile WACh NEO sends automated tailored and personalized SMS messages to mothers during pregnancy and up to 6 weeks postpartum. Messages employ the Information-Motivation-Behavior Skills (IMB) behavioral theory framework to promote 1) maternal implementation of essential newborn care (ENC, which includes early breastfeeding, exclusive breastfeeding, cord care and thermal care), 2) maternal identification of neonatal danger signs and care-seeking, and 3) maternal social support and self-efficacy. Participants can also send SMS to the study nurse, enabling on-demand remote support.Methods: We describe a two-arm unblinded randomized controlled trial (RCT) of the Mobile WACh NEO SMS intervention. The RCT will enroll 5000 third trimester pregnant women in 4 facilities in Kenya and randomize them 1:1 to receive interactive SMS communication or no SMS (control), and conduct follow-up study visits at 2 and 6 weeks postpartum. Neonatal mortality will be compared between arms as the primary outcome. Secondary outcomes include care-seeking, practice of ENC, and psychosocial health. Exploratory analysis will investigate associations between maternal mental health, practice of ENC, care-seeking and SMS engagement.Discussion: This study will contribute evidence on the impact of two-way SMS in a low-income setting on neonatal outcomes, using a rigorous evaluation design. This study will build evidence to fill a gap in understanding drivers of neonatal outcomes and the potential impact of SMS interventions.Trial registrationTrial registration: clinicaltrials.gov, NCT04598165. Registered October 22, 2020 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04598165.

Topical Pramoxine and Hydrocortisone Foam versus Placebo in Relief of Post Partum Episiotomy Symptoms and Wound Healing

1984 ◽  
Vol 29 (2) ◽  
pp. 104-106 ◽  
Author(s):  
I. A. Greer ◽  
A. D. Cameron
Keyword(s):  
Wound Healing ◽  
Randomised Controlled Trial ◽  
Post Partum ◽  
Controlled Trial ◽  
Hydrocortisone Acetate ◽  
Double Blind ◽  
Analgesic Consumption ◽  
Aqueous Foam ◽  
Randomised Controlled

A double-blind randomised controlled trial, comparing pramoxine hydrochloride 1 per cent and hydrocortisone acetate 1 per cent in a mucoadhesive foam base, with simple aqueous foam (B.P.), in relieving episiotomy discomfort and episiotomy healing in 40 patients was carried out. Simple aqueous foam was more effective with regard to wound healing and episiotomy discomfort as measured by analgesic consumption. Pramoxine and hydrocortisone foam offers no advantage over simple aqueous foam in the treatment of post partum episiotomy discomfort.

scholarly journals Probiotics and Maternal Mental Health: A Randomised Controlled Trial among Pregnant Women with Obesity

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Julia P. Dawe ◽  
Lesley M. E. McCowan ◽  
Jess Wilson ◽  
Karaponi A. M. Okesene-Gafa ◽  
Anna S. Serlachius
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Maternal Mental Health ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Internet-based cognitive–behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036482 ◽  
Author(s):  
Daisuke Nishi ◽  
Kotaro Imamura ◽  
Kazuhiro Watanabe ◽  
Erika Obikane ◽  
Natsu Sasaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Cognitive Behavioural Therapy ◽  
Post Partum ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Major Depressive Episodes ◽  
Depressive Episodes

IntroductionThe objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive–behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.Methods and analysisThe target study population will be pregnant women of 16–20 weeks gestation who are currently users of ‘Luna Luna Baby’, the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.Ethics and disseminationThe study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.Trial registration numberUMIN000038190; Pre-results.

scholarly journals Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026484 ◽  
Author(s):  
Juliane Schneider ◽  
Ayala Borghini ◽  
Mathilde Morisod Harari ◽  
Noemie Faure ◽  
Chloé Tenthorey ◽  
...  
Keyword(s):  
Early Intervention ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Self Efficacy ◽  
Maternal Mental Health ◽  
Controlled Trial ◽  
Self Report ◽  
Parental Role ◽  
Child Psychiatrist ◽  
Randomised Controlled

IntroductionPreterm birth may generate significant distress among the parents, who often present with difficulties in appropriating their parental role. Parental stress and low perceived parental self-efficacy may interfere with the infant’s socioemotional and cognitive development, particularly through disrupted parent–infant interactions. Perceived parental self-efficacy represents the belief of efficacy in caring for one’s own infant and successful incarnation of the parental role, as well as the perception of one’s own abilities to complete a specified task. Interventions to support parental role, as well as infant development, are needed, and parental self-efficacy represents a useful indicator to measure the effects of such early interventions.Methods and analysisThis study protocol describes a randomised controlled trial that will test an early intervention in the neonatal intensive care unit (NICU) (JOIN: Joint Observation In Neonatology) carried out by an interdisciplinary staff team. Mothers of preterm neonates born between 28 and 32 6/7 weeks of gestational age are eligible for the study. The intervention consists of a videotaped observation by a clinical child psychologist or child psychiatrist and a study nurse of a period of care delivered to the neonate by the mother and a NICU nurse. The care procedure is followed by an interactive video guidance intended to demonstrate the neonate’s abilities and resources to his parents. The primary outcome will be the difference in the perceived maternal self-efficacy between the intervention and control groups assessed by self-report questionnaires. Secondary outcomes will be maternal mental health, the perception of the parent– infant relationship, maternal responsiveness and the neurodevelopment of the infant at 6 months corrected age.Ethics and disseminationEthical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 496/12). Results from this study will be disseminated at national and international conferences, and in peer-reviewed journals.Trial registration numberNCT02736136, Pre-results.

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