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Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse.
We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting.
This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four 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. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality.
Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74).
Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings.
ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).
With an increase in the number of mobile phone subscribers from 17 million in 2000 to 650 million in 2011, sub-Saharan Africa is experiencing a technological revolution [
Perinatal death is among the most devastating adverse outcome of pregnancy. Over 2.65 million stillbirths and 3 million early neonatal deaths occur each year worldwide [
Perinatal mortality is closely linked to maternal mortality and causes of death are similar, often obstetric in origin, including prolonged labor, preeclampsia, infection, and obstetric hemorrhage [
This report presents the detailed effect of a mobile phone intervention named
The
The study comprised 24 primary health care facilities and pregnant women attending antenatal care at these facilities. Clusters eligible for randomization were the four primary health care facilities in each of the six districts of Unguja Island with the most antenatal care visits in the previous year and a midwife among the staff. There were no major differences between included facilities. They were all primary health care facilities staffed with 1 or 2 midwives and access to basic infrastructure and equipment. The distribution of facilities in relation to hospitals providing Emergency Obstetric and Neonatal care was the same in intervention and control clusters (
Research districts and location of intervention and control health facilities.
Procedures for the selection of the study population.
A Wired Mother with her child.
The Research Council of Zanzibar approved the study protocol on January 27th, 2009. The trial is registered with ClinicalTrials.gov, NCT01821222. All women were informed about the nature and purposes of the study as summarized in the consent form written in the local language, Swahili. All women provided their consent either by signature or fingerprint prior to their inclusion in the study. Women were free to drop out of the study at any time without a change in the quality of care provided. All study results and completed questionnaires were kept confidential and were not accessible to people outside of the research team. The trial is registered after enrollment of participants, due to researchers not being aware of this International Committee of Medical Journal Editors publication demand for relatively benign interventions without individual randomization such as the
The
Women in the intervention group were registered at their first antenatal care visit with date, a phone number, and gestational age. The phone number was either their own or an access phone number of a husband/relative/friend. A specially-designed software that creates an individual pregnancy timeline for each woman and automatically sends text messages to the registered phone number was developed. The content and the frequency of the messages varied throughout the pregnancy and were intensified to weekly messages during the 4 weeks before delivery. The content of the messages focused on health education on topics, such as danger signs in pregnancy and the importance of skilled delivery attendance as well as appointment reminders for the next antenatal care visit. A total of 29,000 SMS were sent during the intervention period. Because the wired mothers intervention was developed in the context of the Ministry of Health in Zanzibar prioritizing to reduce maternal mortality, a voucher system was added to improve access to emergency obstetric care and improve referral mechanisms. Each intervention woman received the phone number of her local midwife and a small voucher of 500 TSH (Tanzanian shilling) allowing to call her. The women were not provided with mobile phones but a referral link was created in the health system through provision of mobile phones to midwives in primary health care facilities, and to midwives/doctors/drivers at the hospital level.
Twenty-four primary health care facilities were eligible for the study and the Ministry of Health agreed to let the facilities be included in the trial (cluster level consent). Meetings were held with staff in participating primary health care facilities to explain the nature and purpose of the trial. The enrolled primary health care facility staff also functioned as research assistants recording an inclusion questionnaire with demographic and covariate information, registering each contact with the women and completing an end-of-study questionnaire 6 weeks after delivery. Research assistants were assigned to the 3 hospitals providing emergency obstetric care and all contact with the enrolled women were similarly recorded. All pregnant women attending their first antenatal care visit in one of the participating primary health care facilities, if willing to participate, were included in the study. All enrolled women received an individual identity number and card. Pregnancy outcome was recorded at delivery for facility-based deliveries and for all included women in a follow-up interview 42 days after delivery. If the women did not return for the end-of-study interview, the research assistant contacted them either directly or by phone. Women attending the standard care received the protocols recommended in Zanzibar in the best format offered in these facilities. Double entry of data was performed in Epidata, transferred, and validated in SPSS.
We evaluated the effect of a mobile phone intervention on the primary outcomes antenatal care (four or more visits) and skilled delivery attendance. These are presented in other papers [
Power calculations were made on the primary outcomes skilled birth attendance and antenatal care attendance and did not take into account the clustering effect. Based on the number of antenatal care attendees from the previous year, the expected of size of the study population during a 3-month enrolment period was estimated to be 1100 women in the intervention group and 1375 women in the control group. Subsequently, a power calculation, based on data on antenatal care visits and skilled delivery attendance from the Tanzanian Demographic Health Survey (DHS 2005), was performed to document if the expected study population would be sufficient to document a true difference between the intervention and the control group [
Primary health care facilities, stratified by district, were assigned by simple random allocation to either the mobile phone intervention or control group (
Analyses were performed based on the “intention to treat” principle and all available data were included in the analysis. We adjusted for the clustering of our data using generalized estimating equations in all logistic regression analyses. We specified an exchangeable working correlation to allow for within cluster correlation and standard errors were based on the robust covariance matrix. We used the traditional logit link, which resulted in odds ratios (ORs) as an effect measure. However, for small values of the risk these can approximately be interpreted as relative risks. For our binary outcome measure, perinatal death yes/no, logistic multilevel analysis was used to analyze if there was a difference in perinatal deaths between the intervention and control groups. In this model, we included all socioeconomic and obstetric confounding variables and eliminated them using backward elimination (age, occupation, education, mobile phone status, residence, parity, previous caesarean section, multiple-gestation pregnancy). Variables with statistical significance were included in the final model. These were age and multiple-gestation pregnancy. Premature delivery, mode of delivery, four or more antenatal care visits, and delivery attendant were considered intermediate variables and not included in the model. We found no interaction between the intervention and explanatory variables. For other secondary outcomes we used a similar approach. Results were expressed as OR for perinatal deaths with 95% CI. Because perinatal mortality is a rare event this can be interpreted as a relative risk. For all models the criterion for significance was set at
Socioeconomic characteristics of the study population were similar in intervention and control clusters. On average, mobile phones were owned by 37% of women, and 58% resided in rural areas (
Overall, 2482 children were live born, 54 were stillborn, and 36 died within the first 42 days of life (
Socioeconomic characteristics of study population.
Variable | Intervention | Control | |
|
|
n (%) | n (%) |
|
|
|
|
|
Number | 12 | 12 |
|
|
|
|
|
Number of women | 1311 (51.4) | 1239 (48.6) |
|
|
|
|
|
<19 | 107 (8.5) | 118 (9.9) |
|
20-24 | 310 (24.6) | 307 (25.6) |
|
25-29 | 371 (29.5) | 309 (25.8) |
|
30-34 | 248 (19.7) | 259 (21.6) |
|
35+ | 222 (17.6) | 204 (17.0) |
|
|
|
|
|
Housewife | 691 (53.0) | 691 (55.8) |
|
Farmer | 286 (21.9) | 241 (19.5) |
|
Sales women | 133 (10.2) | 117 (9.4) |
|
Government | 51 (3.9) | 46 (3.7) |
|
Student | 22 (1.7) | 19 (1.5) |
|
Other | 121 (9.3) | 112 (9.0) |
|
|
|
|
|
No | 204 (16.0) | 220 (18.3) |
|
Primary | 464 (36.3) | 440 (36.7) |
|
Secondary and above | 569 (44.5) | 503 (41.9) |
|
Other (religious education) | 41 (3.2) | 37 (3.1) |
|
|
|
|
|
Owns | 494 (37.8) | 439 (35.5) |
|
Does not own | 813 (62.2) | 796 (64.5) |
|
|
|
|
|
Rural | 743 (56.7) | 730 (58.9) |
|
Urban | 568 (43.3) | 509 (41.1) |
aMissing cases 95
bMissing cases 20
cMissing cases 72
dMissing cases 8
Obstetric characteristics of study population.
Variable | Intervention | Control | |
|
|
n (%) | n (%) |
|
|
|
|
|
Prime | 264 (20.5) | 233 (19.4) |
|
1-2 | 428 (33.2) | 356 (29.6) |
|
3-4 | 292 (22.6) | 297 (24.7) |
|
5+ | 306 (23.7) | 315 (26.2) |
|
|
|
|
|
Yes | 72 (7) | 69 (7) |
|
No | 926 (93) | 872 (93) |
|
|
|
|
|
Multiple gestation | 9 (0.7) | 6 (0.5) |
|
Single gestation | 1297 (99.3) | 1231 (99.5) |
|
|
|
|
|
<37 gestation weeks | 600 (46.3) | 550 (45.9) |
|
At term | 697 (53.7) | 649 (54.1) |
|
|
|
|
|
Yes | 182 (13.9) | 199 (16.1) |
|
No | 1129 (86.8) | 1040 (83.9) |
|
|
|
|
|
Spontaneous vaginal | 1231 (95.9) | 1122 (93.3) |
|
Fundus pressure | 3 (0.2) | 29 (2.4) |
|
Assisted vaginal delivery | 5 (0.4) | 5 (0.4) |
|
Cesarean section | 45 (3.5) | 46 (3.8) |
|
|
|
|
|
Four or more visit | 574 (43.8) | 385 (31.1) |
|
Less than three visits | 737 (56.2) | 854 (68.9) |
|
|
|
|
|
Skilled | 766 (59.7) | 560 (46.6) |
|
Unskilled | 518 (40.3) | 641 (53.4) |
aMissing cases 59
bMissing cases 611
cMissing cases 7
dMissing cases 54
eMissing cases 62
fMissing cases 65
gWe used the WHO definition, whereby skilled delivery attendants are midwifes, doctors, or nurses who have been educated and trained in the skills needed to manage pregnancies, childbirth, and the immediate postnatal period, including the identification, management, and referral of complications in women and newborns. We also included home deliveries assisted by skilled birth attendants, although international consensus has not been reached on this issue.
Number of births, deaths, and mortality rates.
Variable | Intervention | Control | Total | |
|
n | n | n | |
Total births | 1300 | 1236 | 2536 | |
Live birth | 1278 | 1204 | 2482 | |
|
22 | 32 | 54 | |
Fresh | 17 | 24 | 41 | |
Macerated | 5 | 8 | 13 | |
Perinatal mortality | 25 | 44 | 69 | |
Neonatal mortalitya | 18 | 18 | 36 | |
Still birth rate (per 1000 births) | 17 | 26 | 21 | |
Perinatal mortality rate (per 1000 births) | 19 | 36 | 27 | |
Neonatal mortality rateb
|
14 | 15 | 15 |
aMissing cases 7
bDeath<42 days
Variable | Unadjusted ORa,b
|
Adjusted ORa,c
|
|
|
|
|
|
|
Intervention vs control | 0.62 (0.31-1.22) | 0.65 (0.34-1.24) |
|
|
|
|
|
Intervention vs control | 0.49 (0.27-0.90) | 0.50 (0.27-0.93) |
|
|
|
|
|
Intervention vs control | 0.85 (0.37-1.95) | 0.79 (0.36-1.74) |
aOdds ratio
bAdjusted for within-cluster effect
cAdjusted for within-cluster effect and significant variables associated with perinatal mortality
dDeath<42 days
Our findings showed an association between the
The principal strength of our study is that it met the requirement of systematic reviews calling for trials of mobile phone interventions in developing countries [
Because this is the first trial assessing the association between a mobile phone intervention and perinatal mortality we cannot compare with other results. Free et al [
Our results are in line with other studies of perinatal mortality in sub-Saharan Africa, although the perinatal mortality rate for our study (27 per 1000 births) was below the estimates for Tanzania [
A major part of the evidence for sexual and reproductive mHealth comes from the use of text reminders. Studies primarily indicate potential to improve knowledge and awareness [
The policy implications for this study are that text-based mobile phone interventions such as
In conclusion, the
The story of Jina - a wired mother.
Demographic Health Survey
odds ratio
short message service
Tanzanian shilling
World Health Organization
Funding for this study was provided by the Danish International Development Cooperation. The funding institution had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The research team would like to thank Drs Mohammed Jiddawi and Boudewijn Peters for their enthusiastic and persistent concern for the wellbeing of women and children in Zanzibar. The study would not have been possible without them. We would also like to thank all the health workers and pregnant women for their time and input to the study.
Authors' Contributions: All authors were involved in the development of the study design and implementation plan. SL was the principal investigator for the study and SL and BBN are the guarantors. SL, MH, IMB, AS, KS, MHM were responsible for implementation of the study and VR and BBN for overall supervision. SL and BBN did the quantitative analysis. SL wrote the initial draft of the paper. All authors critically reviewed the manuscript and approved the final version.
Conflicts of Interest: None declared.