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Background: Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems. Antenatal care has the potential to reduce maternal morbidity and improve newborns’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting. We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy.Methods: This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation. 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. 24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text-message and voucher component. Primary outcome measure was four or more antenatal care visits during pregnancy. Secondary outcome measures were tetanus vaccination, preventive treatment for malaria, gestational age at last antenatal care visit, and antepartum referral.Results: The mobile phone intervention was associated with an increase in antenatal care attendance. In the intervention group 44% of the women received four or more antenatal care visits versus 31% in the control group (OR, 2.39; 95% CI, 1.03-5.55). There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant.Conclusions: The wired mothers’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services, more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred. Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in resource-limited settings. Trial registration: ClinicalTrials.gov, NCT01821222. © 2014 Lund et al.; licensee BioMed Central Ltd.
Wired mothers is a pragmatic cluster-randomised controlled trial with the primary healthcare facility as the unit of randomisation. The study took place from March 2009 to March 2010 in Zanzibar, United Republic of Tanzania. The study design and intervention have previously been described in detail [12]. The national ethical committee, Research Council of Zanzibar, approved the study protocol on 27th January 2009 with reference number 23. The nature and purposes of the study was summarized in a consent form in the local language Swahili that was presented to all women eligible for inclusion in the study. All participating women provided informed consent either by signature or fingerprint. Women were free to drop up of the study at any time without a change in the quality of care provided to them. Zanzibar is a semi-autonomous part of the United Republic of Tanzania and consists of numerous small islands and two large ones. The wired mothers study took place on the island of Unguja. The island has six districts with 80 healthcare facilities. Of the six districts, two are urban and four rural. As this is a cluster design, eligibility criteria apply to both the primary healthcare facility and individual levels of analysis. In each district, the four primary healthcare facilities with highest level of antenatal care attendance in the preceding year and staffed with at least one midwife were included. At individual level, the study included 2550 women distributed in the 24 primary healthcare facilities (Figure 1). Women who attended antenatal care at selected healthcare facilities, were included on their first antenatal care visit and followed until 42 days after delivery. Women were eligible for study participation irrespective of their mobile phone ownership and literacy status. The terminology “wired mothers” was used to describe women linked to the health system by use of a mobile phone intervention throughout their pregnancy and postpartum period. Procedures for selection of study population. The wired mothers’ intervention consisted of an automated short messaging service (SMS) system providing wired mothers with unidirectional text messaging and a mobile phone voucher system providing the possibility of direct two-way communication between wired mothers and their primary health care providers. While only women with registered phone numbers received text messages, all women in the intervention group were given mobile phone vouchers to contact their local primary health care provider. The aim of the SMS component was to provide simple health education and appointment reminders to encourage attendance at routine antenatal care, skilled delivery attendance and postnatal care. A wired mothers software was developed to automatically generate and sent text messages to registered phone numbers throughout the pregnancy until six weeks after delivery. Based on the gestational age of the women at first antenatal care visit the wired mothers software creates an individual pregnancy time schedule. A welcome message was send at registration regardless of gestational age. Hereafter the content of messages varied depending on individual gestational age. The frequency was two messages per month before gestational week 36 and intensified till two per week from gestational week 36. The information required for the SMS software, gestational age, date and mobile phone number, was gathered during the first antenatal care visit and entered into the web based system. The registered phone numbers were either the women’s own phone or an access phone number of a relative who could relay the text messages. If the women could not provide a phone number she benefitted only from the mobile phone voucher component. The content of the messages were developed by a team of international researchers and local partners from the Ministry of Health in Zanzibar. Message content was standardised with neutral phrasing and provided as simple text in the local language of Swahili. In addition, primary health care facilities randomised for intervention and hospitals were provided with a mobile phone to improve timely referrals between different levels of the health system and to enable health workers in the periphery of the health system to consult patients with higher levels of care. To further improve access to emergency obstetric care, communication and referral links wired mothers were given a phone voucher with modest credit and a card with the phone number of her local primary health care provider allowing all wired mothers to communicate directly with primary health care providers. We evaluated the effect of a mobile phone intervention on two different outcomes. The present paper is concerned with antenatal care whereas another manuscript is concerned with skilled delivery attendance [12]. The primary outcome measure for antenatal care was the number of women receiving four or more antenatal care visits, and secondary outcome measures were quality of care indicators reflecting content and timing of antenatal care services according to the recommended antenatal care package for pregnant women in Zanzibar (Table 1), specifically: number of women receiving anti-tetanus vaccinations, preventive treatment for malaria, gestational age at last antenatal care visit, antepartum referrals and the timing of the mentioned services in gestational age [13]. Recommended timing and content of antenatal visits *Only nulliparous women, women with previous pre-eclampsia and women with diastolic blood pressure above 90. **Additional intervention for use in referral centres but not recommended as routine for resource-limited settings. *** TT1 at first antenatal care visit, TT2 at least four weeks after, TT3 at least six months later, TT4 at least 1 year later, TT5 at least one year later. Five doses are considered to give protection during the rest of the childbearing years. ****1 st dose gestational week 16–28, 2 nd dose gestational week 28–40. There should be at least four weeks between doses. ANC = antenatal care, PIH = Pregnancy Induced Hypertension, IPTp = Intermittent Preventive Treatment in pregnancy. Power calculations were made on the outcomes skilled birth attendance and antenatal care attendance and did not take into account the clustering effect. We started by enrolling antenatal care attendees during a three months period. According to the health management information system records from the previous year we could expect 1,400 women in the intervention group and 1,100 (80%) was estimated to complete a follow up interview 42 days postpartum whereas 1,720 women would be enrolled as non-wired mothers (control group) and an estimated 1,375 (80%) would be followed until 42 days post partum. To estimate whether this sample size was sufficient for detection of public health relevant effects of the intervention, we used data from the Tanzanian Demographic Health Survey (DHS 2005). With a 95% probability and a power of 90% 590 women (295 in each group) were necessary for showing an increase of a relevant size (10% increase in the number of women receiving four or more antenatal care visits). Hence, according to our power calculations, our proposed sample size was sufficient to document an effect of our intervention. Primary healthcare facilities, stratified by district, were assigned by simple random allocation to either the mobile phone intervention or control group. Neither study participants nor clinic staff were masked because of the nature of the intervention requiring overt participation. Analysis accounted for within-cluster correlation of women cared for at the same facility. The average cluster size was 106 women: with a range of 26 to 146. All enrolled women were offered standard maternal health services consisting of at least four antenatal care visits, skilled attendance at delivery and a postnatal visit within the first 48 hours for deliveries taking place outside health facilities [13]. Optimal conditions for provision of quality care in both intervention and control sites were ensured with the distribution of essential drugs for provision of antenatal care, electronic blood pressure meters, weighing scales, hemocues for measuring hemoglobin and urinalysis sticks. The selected primary health care facility staff also functioned as research assistants. Research assistants in intervention facilities received training on the mobile phone intervention. Each district was assigned a supervisor who visited all facilities once a week during the study period for quality control. Supervisors reported any encountered problems to the research team. Demographic and covariate information were recorded with structured questionnaires at inclusion and six weeks after delivery. In between, all contacts with the health system were recorded at antenatal care, delivery and postnatal care visits. All enrolled women received an individual identity number and card. If the women did not return for the end-of-study interview the research assistant contacted them either by phone or directly. Radio announcements were also used to request women to provide the end-of-study interview. Double entry of data was performed in Epidata and transferred and validated in SPSS (version 20). Analyses were performed according to the intention-to-treat principle, and all available data were included in the analysis. Double entry of data was performed in Epidata and transferred and validated in SPSS (version 20) where all statistical analysis were conducted. The primary outcome was antenatal care attendance and logistic regression analysis was performed on the binary outcome of four or more antenatal care visits (yes or no) to assess the impact of the intervention. Because facilities rather than individual women were randomised, we used generalised estimating equations to account for within-cluster correlation in all statistical analysis. The statistical model was developed initially including all variables shown in Table 2 as explanatory variables (including two-factor interactions) in a logistic regression analysis. The model was reduced by removing non significant confounders using backwards elimination. This resulted in a final model including age, literacy, gestational age at first antenatal care visit and intervention status. No interaction with intervention was identified. The logistic regression model was used to assess the primary as well as secondary outcomes. We also performed a Poisson loglinear analysis of continuous antenatal care visits to assess the intervention impact with mean number of antenatal care visits. Timing (in gestational age) of secondary outcomes was analysed using a linaer multiple regression model. Baseline characteristics of the study population. Values are numbers (%) Results were expressed as odds ratios (ORs) for primary and secondary binary outcomes and differences for linear multiple regression with 95% confidence intervals (95% CI). Statistical significance was defined as P < 0.05.
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