Enhancing the uptake of antenatal care, skilled delivery, and post-natal care services among nomadic pastoralist pregnant women in Kenya using beaded Global Position System (GPS) bracelets
| ISRCTN | ISRCTN15438206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15438206 |
- Submission date
- 26/05/2024
- Registration date
- 07/10/2024
- Last edited
- 12/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Maternal and child health has been a concern and priority for the global community as articulated in SDG number 3.4 and equally articulated in Kenya’s Big Four agenda. Kenya continues to have a high maternal death rate, despite the commitment from the government to address the issue. Most maternal deaths are preventable as the healthcare solutions to prevent or manage complications are well known. All women need access to antenatal care during pregnancy, skilled care during childbirth, and postnatal care after childbirth. To provide adequate care during pregnancy, the antenatal profile needs to be conducted for all pregnant mothers. However, as a result of adverse climatic change which has made the pastoralist community more mobile and thus negatively affecting the pastoralists in northern Kenya, expectant women are unable to access antenatal care, skill delivery, and postnatal care services as per national and international standards. This is also because the provided facilities are static, ill-equipped, and out of reach, coupled with high illiteracy levels among the pastoralist community and more so the women. This study will involve collecting data about the impact of GPS tracking on maternal and neonatal health. The findings could inform policies and interventions to improve care delivery in pastoralist communities. Therefore, this study is an attempt to assess the effectiveness of Global Position System (GPS) bracelets in improving the uptake of antenatal care, health facility delivery, and postnatal care services among mobile/pastoralist communities in Kenya.
Who can participate?
Pastoralist pregnant women over 18 years old who are less than 16 weeks pregnant
What does the study involve?
Participants are randomly allocated to a group that receives GPS tracking during antenatal and postnatal care or a control group that does not. By comparing outcomes between the two groups, the researchers can determine whether GPS tracking improves care utilization, health outcomes or other relevant factors.
What are the possible benefits and risks of participating?
Occasionally one or more of the following potential side effects of taking blood samples may occur: pain, bruising, and slight bleeding. A trained technician will be drawing the blood. The treatment or procedure may involve risks that are currently unforeseeable. There are no known risks or discomforts from the stool and urine collection technique. GPS magnetic fields at these levels do not cause harmful effects.
The study provides health benefits to participants by identifying any condition or infection that might complicate the pregnancy and delivery outcome. The health benefits are doing laboratory tests like HIV, hemoglobin level, presence of any sexually transmitted infection, urinary tract infection, presence of malaria parasites, blood grouping, and any intestinal parasites. By doing all this the participants can benefit from preventing transmission of HIV from mother to child, anemia, and hemolytic diseases in newborns.
Where is the study run from?
1. African Academy of Sciences (Kenya)
2. University of Pécs (Hungary)
When is the study starting and how long is it expected to run for?
September 2021 to September 2024
Who is funding the study?
This research was supported by Grand Challenge Africa (Grant Nr. GCA 011/114) and the National Research, Development and Innovation Fund of Hungary (NKFI FK-147404, ÚNKP-23-4-II-PTE-2061, TKP-2021-EGA-10). Project No. RRF-2.3.1-21-2022-00012, titled National Laboratory on Human Reproduction, has been implemented with the support provided by the Recovery and Resilience Facility of the European Union within the framework of Programme Széchenyi Plan Plus, and this project has received funding from the HUN-REN Hungarian Research Network.
Who is the main contact?
Dahabo Adi Galgalo, bwqi8p@pte.hu, adi.dahabo@yahoo.com
Contact information
Principal Investigator
Moyale Sub county
Marsabit
60700
Kenya
 ORCID ID |
0000-0002-9508-7182 |
|---|---|
| Phone | +254 (0)711229885 |
| bwqi8p@pte.hu |
Public
National Laboratory on Human Reproduction
University of Pécs
H-7622
Szepesy Ignác u. 1-3
Pecs
7621
Hungary
| Phone | +72501500/38070 |
|---|---|
| varnagy.akos@pte.hu |
Scientific
Vörösmarty u. 4, H-762
Szepesy Ignác u. 1-3
Pecs
7621
Hungary
| ORCID ID |
0000-0002-4059-104X |
|---|---|
| Phone | +36 (0)72 513-670/690 |
| premusz.viktoria@pte.hu |
Study information
| Study design | Unmasked randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluating the effectiveness of global position system (GPS) bracelets to improve the uptake of antenatal care, health facility delivery, and post-natal care services among mobile/pastoralist communities in Kenya |
| Study objectives | This study aims to determine the effectiveness of Global Positioning System (GPS) beaded bracelets on the utilization of antenatal, health facility delivery, and postnatal care among pastoralist pregnant women 1. Null hypothesis: There is no difference in the utilization of antenatal care, health facility delivery, and postnatal care among pastoralist pregnant women tracked by using beaded Global Positioning System bracelets 2. Alternative hypothesis: There is a difference in the utilization of antenatal care, health facility delivery, and postnatal care among pastoralist pregnant women tracked by using beaded Global Positioning System bracelets |
| Ethics approval(s) |
Approved 08/11/2021, Amref Ethics and Scientific Review Committee (ESRC) (PO Box 30125-00100, Nairobi, -, Kenya; +254 (0)20 688 4000; esrc.kenya@amref.org), ref: AMREF - ESRC P1062/2021 |
| Health condition(s) or problem(s) studied | Enhancing the uptake of maternal and child health services in pastoralist pregnant women |
| Intervention | Participants were randomly chosen through computer-generated numbers and allocated into two groups (with beaded GPS bracelets and without). Participants were not masked because the wearable GPS was visible to others. The devices (GPS) were dressed with beads to entice participants to wear them at all times. Participants were given the devices upon determination of eligibility and consent to participate, and they were instructed to keep them throughout the pregnancy. The medical team conducts a health outreach program that provides antenatal care, skilled delivery, and postnatal care. Women with GPS are tracked and their location is identified and service given. Women without GPS are not tracked but follow the normal outreach program process (If they come, service is given but if they don’t come no follow-up is done). Duration of Intervention and follow-up: 6 months during pregnancy and 9 months after delivery (15 months). GPS devices are given to women and then they are followed up from 12 weeks of pregnancy up to the delivery and 9 months after a successful birth of a baby for immunization. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Beaded Global Positioning System bracelets |
| Primary outcome measure | 1. Attendance of more than four ANC visits, received skilled/health facility delivery, and received postnatal care among the intervention and control participants, collected using a questionnaire at the end of pregnancy for ANC uptake, skilled delivery for those who will deliver at hospital and uptake of first postnatal care after delivery. 2. Maternal death and infant death: 2.1. Maternal death: death whether it's during pregnancy, childbirth, or within 42 days of termination of pregnancy within the pastoralist community throughout the intervention 2.2. Infant death: the number of newborns in a pastoralist community understudy dying under 1 year of age divided by the number of resident live births for the same geographic area. This will be done at the end of the intervention. |
| Secondary outcome measures | 1. Demographic factors: age, level of education, literacy level, socioeconomic status, marital status, polygamous or monogamous marital status. This was collected using a standard questionnaire at the beginning of the study 2. Geographic context: nomadic lifestyle, distance from health facility, remoteness, and cultural practices. This was collected using a standard questionnaire throughout the study 3. Media exposure and awareness: radio with local FM, TV, and community health campaigns. This was collected using a standard questionnaire at the beginning of the study 4. Quality of care of ANC and delivery services given at health facilities. Some of the factors contributing to quality service to clients e.g. respectful care, waiting times, and provider competence will be considered. This was collected using a standard questionnaire throughout the study. |
| Overall study start date | 10/09/2021 |
| Completion date | 10/09/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 49 Years |
| Sex | Female |
| Target number of participants | 126 |
| Total final enrolment | 105 |
| Key inclusion criteria | 1. Pastoralist pregnant women 2. >18 years old 3. <16 weeks pregnant 4. Able to understand study procedures and to comply with them for the entire length of the study 5. Consented to wear beaded GPS bracelets 6. Consented to have laboratory procedures conducted to complete the profile 7. Consents to screening and enrollment interviews 8. If successful delivery, consent to have the baby evaluated and vaccinated |
| Key exclusion criteria | 1. Pregnancy >12 weeks gestation 2. No consent 3. Women with a previous history of complicated pregnancy 4. Age <18 years 5. Physical disability 6. Women who do not deliver or if they abort 7. If the child dies |
| Date of first enrolment | 29/11/2021 |
| Date of final enrolment | 27/12/2021 |
Locations
Countries of recruitment
- Kenya
Study participating centre
Moyale Sub County
60700
Kenya
Sponsor information
Research organisation
PO Box 24916-00502
Nairobi
-
Kenya
| Phone | +254 (0)709 158 000/100/101/102/103, +254 (0)736 888 001, +254 (0)725 290 145 |
|---|---|
| communication@aasciences.africa | |
| Website | https://aasciences.africa/ |
"ROR" |
https://ror.org/05px9k635 |
University/education
Doctoral School of Health Sciences
H-7621 Pécs, Vörösmarty M. u. 4
Pécs
H-7621
Hungary
| Phone | +36 (0)72 513-670/690 |
|---|---|
| doktoriiskola@etk.pte.hu | |
| Website | https://international.pte.hu/study-programs/phd-health-sciences |
|
"ROR" |
https://ror.org/037b5pv06 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Universität Pécs, University of Pécs, PTE
- Location
- Hungary
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 12/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The plan is to publish the research in a good journal with a higher impact factor and Q1 category. The researchers will publish their methods, processes, and findings in open-access peer-reviewed journals. They will not only share “what works” but also the “road map” of how they did it so that replication and adaptation to other populations and settings becomes possible. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dahabo Adi Galgalo (adi.dahabo@yahoo.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/05/2025 | 12/05/2025 | Yes | No |
Editorial Notes
12/05/2025: Publication reference added.
28/05/2024: Study's existence confirmed by the Amref Ethics and Scientific Review Committee (ESRC).
