Antenatal Care and DeliveryNCT02643953
Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal Mortality in Nigeria
A study testing Incentives and Community in people with Antenatal Care and Delivery, run by University of Ottawa.
Trial summary
Background: Nigeria has the second highest absolute number of maternal deaths and perinatal deaths in the world. The country contributes 14% of all maternal deaths worldwide, second only to India. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Care and Delivery
- What is being tested?
- Incentives and Community
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who give birth (including cases of foetal or infant death) in comparative health wards and who receive their usual pattern of utilization of maternity care.
- Women who have antenatal care record at one of the study facilities
Who cannot join
- Women outside the research regions who fail to meet any of the inclusion criteria will be excluded
- Women who do not have an antenatal care record at one of the study facilities
About this study
Official title: Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal and Perinatal Mortality in Nigeria: A Randomized Control Trial
Background: Nigeria has the second highest absolute number of maternal deaths and perinatal deaths in the world. The country contributes 14% of all maternal deaths worldwide, second only to India. Although all parts of the country are affected, most maternal, and perinatal deaths occur in the northeast and northwest geo-political zones, where women have limited access to evidence-based maternal and newborn health services. Affected women and families are mainly those who have little or no formal education, who are poor and marginalized, and who live in rural and sub-urban communities.
Problem: Research carried out in various regions of Nigeria has shown that insufficient access to pregnancy health services is a major factor that places women at high risk of adverse maternal and perinatal outcomes. Maternal care provided within Nigeria's numerous local Primary Health Centres (PHCs) is an efficient and practical avenue for reaching vulnerable women and their newborn infants, and PHC use is strongly encouraged by the Nigerian Federal Ministry of Health.
Read more
Research Question and Objective: The key research question and objectives are as follows: 1) To determine the main factors that prevent vulnerable women from using PHCs or receiving maternal and neonatal care therein; 2) To identify effective community level interventions for improving women's access to maternal health services, as a means to reduce maternal and perinatal morbidity and mortality in Nigeria.
Methodology: This study will complete a community-based, multi-site project using a mixed methods approach. The project will be done in three sequential phases: A data gathering phase (Phase 1), an intervention phase (Phase 2), and the implementation of the findings (Phase 3). The study will be conducted over 54-months in six communities, and another six communities of similar status will serve as control sites. During Phases 1-3, surveys about maternal health services utilization will be carried out at baseline, midterm and completion points of the project.
Potential Impact: Increasing women's access to evidence-based maternity care is likely a direct way to reduce maternal and neonatal mortality in Nigeria. The proposed project will determine how we can effectively increase access to PHCs, and then bring those findings into a policy and program format that can be applied across the country.
Read the detailed description
Intervention Design: This intervention will be a randomized cluster trial design: interventions will be implemented in 6 health wards/communities (4 rural/peri-urban and 2 urban) while 6 health wards/communities with similar socio-demographic characteristics will serve as controls (where the intervention is not implemented). Including some urban or peri-urban clusters enables one to capture both rural and urban data about attitudes toward PMC maternal care (Phase 1), and the efficacy of the intervention to increase PMC use (Phase 2). It also enables one to see if attitudes (Phase 1 data) and the intervention (Phase 2) are different in rural vs. urban settings. This would be described as being a secondary analysis of the main data derived during Phase 1 and Phase 2.
The Intervention: The actual intervention activities to be applied will be finalized after the intervention workshop, following Phase 1. However, based on current knowledge, the intervention will need to be multi-faceted, and will possibly consist of 1) provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services; 5) outreach services by PHCs; 6) PHC strengthening including training of health providers; and 7) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery.
Control Group: The control group will comprise women who are eligible and give birth (including cases of fetal or infant death) in the intervention period in comparative health wards, who will not receive the interventions and who will continue to receive their usual pattern of utilization of maternity care. To ensure comparability of social, economic and cultural factors between the intervention and control groups, the health wards that will serve as controls will have been selected from the same States as the intervention health wards. Hence, the study will have paired intervention-control groups from the same States, but distanced enough from one another (in separate LGAs) to reduce the potential effects of study contamination (i.e., the intervention is known or adopted in a control region). However, should the intervention prove to be effective, the investigators will be recommending the use of the same intervention activities in the control sites, as well as throughout the country.
- Conditions
- Antenatal Care and Delivery
- Being tested
- Incentives, Community
- Keywords
- Maternal Health, Maternal Mortality, Global Health, RCT
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncentivesBehavioural
- provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services
CommunityBehavioural
- outreach services by PHCs; 6) PHC strengthening including training of health providers; and 2) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This arm includes women who are eligible and give birth (including cases of fetal or infant death) in the intervention period in comparative health wards, who will not receive the interventions and who will continue to receive their usual pattern of utilization of maternity care. |
| Other | Experimental | The intervention will need to be multi-faceted, and will consist of provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; conditional cash transfers to promote uptake of services and targeted community health education and advocacy activities Receives: Behavioral: Incentives; Behavioral: Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome variable will be the proportion of women, among those who give birth following the start of the intervention, who use PHCs for antenatal, delivery and postnatal care, in the intervention and control health wards.
Measured: Up to 48 months
Secondary outcomes (1)
A secondary outcome will be the proportion of women giving birth and attending PHCs who have received standard/quality antenatal, intrapartum and postnatal care.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Antenatal Care and DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanni Yaya, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643953
- Sponsor's protocol ID
- 108041
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Harrison KA. The struggle to reduce high maternal mortality in Nigeria. Afr J Reprod Health. 2009 Sep;13(3):9-20.
PubMed 20690258Harrison KA. Are traditional birth attendants good for improving maternal and perinatal health? No. BMJ. 2011 Jun 14;342:d3308. doi: 10.1136/bmj.d3308. No abstract available.
PubMed 21673000Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, Lopez AD, Lozano R, Murray CJ. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5. Lancet. 2010 May 8;375(9726):1609-23. doi: 10.1016/S0140-6736(10)60518-1. Epub 2010 Apr 9.
PubMed 20382417Lassi ZS, Bhutta ZA. Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes. Cochrane Database Syst Rev. 2015 Mar 23;2015(3):CD007754. doi: 10.1002/14651858.CD007754.pub3.
PubMed 25803792Montoya A, Calvert C, Filippi V. Explaining differences in maternal mortality levels in sub-Saharan African hospitals: a systematic review and meta-analysis. Int Health. 2014 Mar;6(1):12-22. doi: 10.1093/inthealth/iht037. Epub 2014 Feb 18.
PubMed 24550236Moyer CA, Dako-Gyeke P, Adanu RM. Facility-based delivery and maternal and early neonatal mortality in sub-Saharan Africa: a regional review of the literature. Afr J Reprod Health. 2013 Sep;17(3):30-43.
PubMed 24069765Buor D, Bream K. An analysis of the determinants of maternal mortality in sub-Saharan Africa. J Womens Health (Larchmt). 2004 Oct;13(8):926-38. doi: 10.1089/jwh.2004.13.926.
PubMed 15671708Chinkhumba J, De Allegri M, Muula AS, Robberstad B. Maternal and perinatal mortality by place of delivery in sub-Saharan Africa: a meta-analysis of population-based cohort studies. BMC Public Health. 2014 Sep 28;14:1014. doi: 10.1186/1471-2458-14-1014.
PubMed 25263746Nkwo PO, Lawani LO, Ezugwu EC, Iyoke CA, Ubesie AC, Onoh RC. Correlates of poor perinatal outcomes in non-hospital births in the context of weak health system: the Nigerian experience. BMC Pregnancy Childbirth. 2014 Sep 30;14:341. doi: 10.1186/1471-2393-14-341.
PubMed 25271134Fapohunda B, Orobaton N. Factors influencing the selection of delivery with no one present in Northern Nigeria: implications for policy and programs. Int J Womens Health. 2014 Jan 31;6:171-83. doi: 10.2147/IJWH.S54628. eCollection 2014.
PubMed 24516341Aremu O, Lawoko S, Dalal K. Neighborhood socioeconomic disadvantage, individual wealth status and patterns of delivery care utilization in Nigeria: a multilevel discrete choice analysis. Int J Womens Health. 2011;3:167-74. doi: 10.2147/IJWH.S21783. Epub 2011 Jul 4.
PubMed 21792338Adamu YM, Salihu HM. Barriers to the use of antenatal and obstetric care services in rural Kano, Nigeria. J Obstet Gynaecol. 2002 Nov;22(6):600-3. doi: 10.1080/0144361021000020349.
PubMed 12554244Bhutta ZA, Ali S, Cousens S, Ali TM, Haider BA, Rizvi A, Okong P, Bhutta SZ, Black RE. Alma-Ata: Rebirth and Revision 6 Interventions to address maternal, newborn, and child survival: what difference can integrated primary health care strategies make? Lancet. 2008 Sep 13;372(9642):972-89. doi: 10.1016/S0140-6736(08)61407-5.
PubMed 18790320Rosato M, Laverack G, Grabman LH, Tripathy P, Nair N, Mwansambo C, Azad K, Morrison J, Bhutta Z, Perry H, Rifkin S, Costello A. Community participation: lessons for maternal, newborn, and child health. Lancet. 2008 Sep 13;372(9642):962-71. doi: 10.1016/S0140-6736(08)61406-3.
PubMed 18790319Lassi ZS, Haider BA, Bhutta ZA. Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD007754. doi: 10.1002/14651858.CD007754.pub2.
PubMed 21069697
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Women's Access to Skilled Pregnancy Care to Reduce Maternal and Perinatal Mortality in Nigeria: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02643953
- Acronym / sponsor ID
- 108041
- Conditions
- Antenatal Care and Delivery
- Keywords
- Maternal Health, Maternal Mortality, Global Health, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Nigeria has the second highest absolute number of maternal deaths and perinatal deaths in the world. The country contributes 14% of all maternal deaths worldwide, second only to India. Although all parts of the country are affected, most maternal, and perinatal deaths occur in the northeast and northwest geo-political zones, where women have limited access to evidence-based maternal and newborn health services. Affected women and families are mainly those who have little or no formal education, who are poor and marginalized, and who live in rural and sub-urban communities.
Problem: Research carried out in various regions of Nigeria has shown that insufficient access to pregnancy health services is a major factor that places women at high risk of adverse maternal and perinatal outcomes. Maternal care provided within Nigeria's numerous local Primary Health Centres (PHCs) is an efficient and practical avenue for reaching vulnerable women and their newborn infants, and PHC use is strongly encouraged by the Nigerian Federal Ministry of Health.
Research Question and Objective: The key research question and objectives are as follows: 1) To determine the main factors that prevent vulnerable women from using PHCs or receiving maternal and neonatal care therein; 2) To identify effective community level interventions for improving women's access to maternal health services, as a means to reduce maternal and perinatal morbidity and mortality in Nigeria.
Methodology: This study will complete a community-based, multi-site project using a mixed methods approach. The project will be done in three sequential phases: A data gathering phase (Phase 1), an intervention phase (Phase 2), and the implementation of the findings (Phase 3). The study will be conducted over 54-months in six communities, and another six communities of similar status will serve as control sites. During Phases 1-3, surveys about maternal health services utilization will be carried out at baseline, midterm and completion points of the project.
Potential Impact: Increasing women's access to evidence-based maternity care is likely a direct way to reduce maternal and neonatal mortality in Nigeria. The proposed project will determine how we can effectively increase access to PHCs, and then bring those findings into a policy and program format that can be applied across the country.
Detailed description
Intervention Design: This intervention will be a randomized cluster trial design: interventions will be implemented in 6 health wards/communities (4 rural/peri-urban and 2 urban) while 6 health wards/communities with similar socio-demographic characteristics will serve as controls (where the intervention is not implemented). Including some urban or peri-urban clusters enables one to capture both rural and urban data about attitudes toward PMC maternal care (Phase 1), and the efficacy of the intervention to increase PMC use (Phase 2). It also enables one to see if attitudes (Phase 1 data) and the intervention (Phase 2) are different in rural vs. urban settings. This would be described as being a secondary analysis of the main data derived during Phase 1 and Phase 2.
The Intervention: The actual intervention activities to be applied will be finalized after the intervention workshop, following Phase 1. However, based on current knowledge, the intervention will need to be multi-faceted, and will possibly consist of 1) provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services; 5) outreach services by PHCs; 6) PHC strengthening including training of health providers; and 7) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery.
Control Group: The control group will comprise women who are eligible and give birth (including cases of fetal or infant death) in the intervention period in comparative health wards, who will not receive the interventions and who will continue to receive their usual pattern of utilization of maternity care. To ensure comparability of social, economic and cultural factors between the intervention and control groups, the health wards that will serve as controls will have been selected from the same States as the intervention health wards. Hence, the study will have paired intervention-control groups from the same States, but distanced enough from one another (in separate LGAs) to reduce the potential effects of study contamination (i.e., the intervention is known or adopted in a control region). However, should the intervention prove to be effective, the investigators will be recommending the use of the same intervention activities in the control sites, as well as throughout the country.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This arm includes women who are eligible and give birth (including cases of fetal or infant death) in the intervention period in comparative health wards, who will not receive the interventions and who will continue to receive their usual pattern of utilization of maternity care. |
| Other | Experimental | Behavioral: Incentives, Behavioral: CommunityThe intervention will need to be multi-faceted, and will consist of provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; conditional cash transfers to promote uptake of services and targeted community health education and advocacy activities |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women who give birth (including cases of foetal or infant death) in comparative health wards and who receive their usual pattern of utilization of maternity care.
- Women who have antenatal care record at one of the study facilities
Key exclusion criteria (2 listed)
- Women outside the research regions who fail to meet any of the inclusion criteria will be excluded
- Women who do not have an antenatal care record at one of the study facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentives1) provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services | Behavioural | Other |
| Community1) outreach services by PHCs; 6) PHC strengthening including training of health providers; and 2) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery. | Behavioural | Other |
Primary outcome
The main outcome variable will be the proportion of women, among those who give birth following the start of the intervention, who use PHCs for antenatal, delivery and postnatal care, in the intervention and control health wards.
Time frame: Up to 48 months
1 secondary outcome
A secondary outcome will be the proportion of women giving birth and attending PHCs who have received standard/quality antenatal, intrapartum and postnatal care.
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Background: PubMed 20690258Harrison KA. The struggle to reduce high maternal mortality in Nigeria. Afr J Reprod Health. 2009 Sep;13(3):9-20.
- Background: PubMed 21673000Harrison KA. Are traditional birth attendants good for improving maternal and perinatal health? No. BMJ. 2011 Jun 14;342:d3308. doi: 10.1136/bmj.d3308. No abstract available.
- Background: PubMed 20382417Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, Lopez AD, Lozano R, Murray CJ. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5. Lancet. 2010 May 8;375(9726):1609-23. doi: 10.1016/S0140-6736(10)60518-1. Epub 2010 Apr 9.
- Background: PubMed 25803792Lassi ZS, Bhutta ZA. Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes. Cochrane Database Syst Rev. 2015 Mar 23;2015(3):CD007754. doi: 10.1002/14651858.CD007754.pub3.
- Background: PubMed 24550236Montoya A, Calvert C, Filippi V. Explaining differences in maternal mortality levels in sub-Saharan African hospitals: a systematic review and meta-analysis. Int Health. 2014 Mar;6(1):12-22. doi: 10.1093/inthealth/iht037. Epub 2014 Feb 18.
- Background: PubMed 24069765Moyer CA, Dako-Gyeke P, Adanu RM. Facility-based delivery and maternal and early neonatal mortality in sub-Saharan Africa: a regional review of the literature. Afr J Reprod Health. 2013 Sep;17(3):30-43.
- Background: PubMed 15671708Buor D, Bream K. An analysis of the determinants of maternal mortality in sub-Saharan Africa. J Womens Health (Larchmt). 2004 Oct;13(8):926-38. doi: 10.1089/jwh.2004.13.926.
- Background: PubMed 25263746Chinkhumba J, De Allegri M, Muula AS, Robberstad B. Maternal and perinatal mortality by place of delivery in sub-Saharan Africa: a meta-analysis of population-based cohort studies. BMC Public Health. 2014 Sep 28;14:1014. doi: 10.1186/1471-2458-14-1014.
- Background: PubMed 25271134Nkwo PO, Lawani LO, Ezugwu EC, Iyoke CA, Ubesie AC, Onoh RC. Correlates of poor perinatal outcomes in non-hospital births in the context of weak health system: the Nigerian experience. BMC Pregnancy Childbirth. 2014 Sep 30;14:341. doi: 10.1186/1471-2393-14-341.
- Background: PubMed 24516341Fapohunda B, Orobaton N. Factors influencing the selection of delivery with no one present in Northern Nigeria: implications for policy and programs. Int J Womens Health. 2014 Jan 31;6:171-83. doi: 10.2147/IJWH.S54628. eCollection 2014.
- Background: PubMed 21792338Aremu O, Lawoko S, Dalal K. Neighborhood socioeconomic disadvantage, individual wealth status and patterns of delivery care utilization in Nigeria: a multilevel discrete choice analysis. Int J Womens Health. 2011;3:167-74. doi: 10.2147/IJWH.S21783. Epub 2011 Jul 4.
- Background: PubMed 12554244Adamu YM, Salihu HM. Barriers to the use of antenatal and obstetric care services in rural Kano, Nigeria. J Obstet Gynaecol. 2002 Nov;22(6):600-3. doi: 10.1080/0144361021000020349.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives and Community in people with Antenatal Care and Delivery, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome variable will be the proportion of women, among those who give birth following the start of the intervention, who use PHCs for antenatal, delivery and postnatal care, in the intervention and control health wards. (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643953, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.