Maternal Morbidity and MortalityEmONCNCT01073488
Emergency Obstetric and Neonatal Care: The EmONC Trial
A study testing Community Mobilization, HBLSS and facility improvement in people with Maternal Morbidity and Mortality and Stillbirth and Neonatal Mortality, run by NICHD Global Network for Women's and Children's Health at 7 sites in 6 countries.
Trial summary
The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Morbidity and Mortality, Stillbirth and Neonatal Mortality
- What is being tested?
- Community Mobilization, HBLSS and facility improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267,181 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Dec 2008to Oct 2011
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women living in and/or delivering within the study cluster
- Consent provided
- Exclusion Criteria: Eligible pregnant women who do not consent
Who cannot join
None listed.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
India2 sites
Jawaharlal Nehru Medical College
Belagavi
Indira Gandhi Government Medical College
Nagpur
About this study
Official title: Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)
The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in >28 week or >1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.
Read the detailed description
Maternal death, stillbirth, early neonatal death, and obstetric fistula are among the most devastating adverse outcomes of pregnancy. Existing interventions could avert the majority of maternal and neonatal deaths; however, those women at greatest risk are least likely to have access to interventions delivered through the formal health care system. In many developing countries, most deliveries in rural areas and a significant number in urban areas are conducted at home without skilled attendance, circumstances which pose a high risk for both mothers and their neonates. The EmONC trial is designed to evaluate a comprehensive intervention encompassing community mobilization to establish and sustain mechanisms of transport and payment and to drive client-oriented emergency obstetrical and neonatal care. The intervention includes teaching recognition of prolonged labor, infection, preeclampsia and hemorrhage, and the use of appropriate stabilization methods by all community birth attendants. In addition, poor access to quality emergency obstetric and neonatal care in a sustainable manner will be addressed. To evaluate the effectiveness of this approach, a cluster-randomized trial is required to assess whether Cluster EmONC teams can work with the community and health care system to reduce adverse pregnancy outcomes in diverse settings where the majority of deliveries occur at home or at a health clinic with few or no available EmONC interventions. To accomplish the intervention, a train-the-trainer approach will be used. Master trainers will facilitate central and regional training sessions for Country trainers organized around the areas of community mobilization; birth attendant skills; and EmONC referral facility improvements. The Country trainers will then support training and related activities in the intervention clusters, predominantly focusing on these three areas. The study population includes pregnant women (and their neonates) living and delivering in the 108 study clusters. The study clusters are largely rural, geographically distinct communities, each of which have approximately 300 annual deliveries. The women will be enrolled at or after 20 weeks gestation and followed to 42 days post delivery. The total duration of the trial will be 24 months.
- Being tested
- Community Mobilization, HBLSS and facility improvement
- Keywords
- Pregnancy, Maternal child health, Developing countries, Stillbirth, Neonatal mortality, Maternal mortality, Community intervention, Community mobilization, Home-based Life Saving Skills
- Medical subject headings
- Stillbirth, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Mobilization, HBLSS and facility improvementBehavioural
Also called CM
Mobilization of the community, with special emphasis on pregnant women and their families, to identify resources and solutions to improve maternal and neonatal mortality, home-based life savings skills (HBLSS) for community birth attendants and facility improvement activities.
| Study group | Role | What they receive |
|---|---|---|
| EMONC: Community mobilization, HBLSS and Facility Improvement | Experimental | The intervention group received training in community mobilization activities, Home Based Life Saving Skills (HBLSS) and facility improvement. Receives: Behavioral: Community Mobilization, HBLSS and facility improvement |
| Control | No intervention | The control group did not receive an intervention, but collected outcome data through a baseline maternal/newborn birth registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate
Measured: 7 days post delivery
Secondary outcomes (7)
Maternal mortality rate
Measured: 42 days post delivery
Maternal morbidity rates
Measured: 42 days post delivery
Stillbirth rate
Measured: Delivery
7-day neonatal mortality rate
Measured: 7 days post delivery
28-day neonatal mortality rate
Measured: 28 days post delivery
Rates of mothers transported to a referral hospital.
Measured: 42 days post delivery
Rates of neonates/infants transported to a referral hospital
Measured: 42 days post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal Morbidity and MortalityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267,181 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Robert Goldenberg, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073488
- Sponsor's protocol ID
- GN EmONC
- Acronym
- EmONC
- Status last verified
- Nov 2013
- First submitted
- 21 Feb 2010
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pasha O, McClure EM, Wright LL, Saleem S, Goudar SS, Chomba E, Patel A, Esamai F, Garces A, Althabe F, Kodkany B, Mabeya H, Manasyan A, Carlo WA, Derman RJ, Hibberd PL, Liechty EK, Krebs N, Hambidge KM, Buekens P, Moore J, Jobe AH, Koso-Thomas M, Wallace DD, Stalls S, Goldenberg RL; EMONC Trial Investigators. A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial. BMC Med. 2013 Oct 3;11:215. doi: 10.1186/1741-7015-11-215.
PubMed 24090370Pasha O, Goldenberg RL, McClure EM, Saleem S, Goudar SS, Althabe F, Patel A, Esamai F, Garces A, Chomba E, Mazariegos M, Kodkany B, Belizan JM, Derman RJ, Hibberd PL, Carlo WA, Liechty EA, Hambidge KM, Buekens P, Wallace D, Howard-Grabman L, Stalls S, Koso-Thomas M, Jobe AH, Wright LL. Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the Global Network's EmONC trial). BMC Pregnancy Childbirth. 2010 Dec 14;10:82. doi: 10.1186/1471-2393-10-82.
PubMed 21156060
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)
- ClinicalTrials.gov ID
- NCT01073488
- Acronym / sponsor ID
- EmONC / GN EmONC
- Keywords
- Pregnancy, Maternal child health, Developing countries, Stillbirth, Neonatal mortality, Maternal mortality, Community intervention, Community mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267,181 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Feb 2010 (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.
The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in >28 week or >1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.
Detailed description
Maternal death, stillbirth, early neonatal death, and obstetric fistula are among the most devastating adverse outcomes of pregnancy. Existing interventions could avert the majority of maternal and neonatal deaths; however, those women at greatest risk are least likely to have access to interventions delivered through the formal health care system. In many developing countries, most deliveries in rural areas and a significant number in urban areas are conducted at home without skilled attendance, circumstances which pose a high risk for both mothers and their neonates. The EmONC trial is designed to evaluate a comprehensive intervention encompassing community mobilization to establish and sustain mechanisms of transport and payment and to drive client-oriented emergency obstetrical and neonatal care. The intervention includes teaching recognition of prolonged labor, infection, preeclampsia and hemorrhage, and the use of appropriate stabilization methods by all community birth attendants. In addition, poor access to quality emergency obstetric and neonatal care in a sustainable manner will be addressed. To evaluate the effectiveness of this approach, a cluster-randomized trial is required to assess whether Cluster EmONC teams can work with the community and health care system to reduce adverse pregnancy outcomes in diverse settings where the majority of deliveries occur at home or at a health clinic with few or no available EmONC interventions. To accomplish the intervention, a train-the-trainer approach will be used. Master trainers will facilitate central and regional training sessions for Country trainers organized around the areas of community mobilization; birth attendant skills; and EmONC referral facility improvements. The Country trainers will then support training and related activities in the intervention clusters, predominantly focusing on these three areas. The study population includes pregnant women (and their neonates) living and delivering in the 108 study clusters. The study clusters are largely rural, geographically distinct communities, each of which have approximately 300 annual deliveries. The women will be enrolled at or after 20 weeks gestation and followed to 42 days post delivery. The total duration of the trial will be 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMONC: Community mobilization, HBLSS and Facility Improvement | Experimental | Behavioral: Community Mobilization, HBLSS and facility improvementThe intervention group received training in community mobilization activities, Home Based Life Saving Skills (HBLSS) and facility improvement. |
| Control | No intervention | –The control group did not receive an intervention, but collected outcome data through a baseline maternal/newborn birth registry. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women living in and/or delivering within the study cluster
- Consent provided
- Exclusion Criteria: Eligible pregnant women who do not consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Community Mobilization, HBLSS and facility improvementAlso: CMMobilization of the community, with special emphasis on pregnant women and their families, to identify resources and solutions to improve maternal and neonatal mortality, home-based life savings skills (HBLSS) for community birth attendants and facility improvement activities. | Behavioural | EMONC: Community mobilization, HBLSS and Facility Improvement |
Primary outcome
Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate
Time frame: 7 days post delivery
7 secondary outcomes
Maternal mortality rate
Time frame: 42 days post delivery
Maternal morbidity rates
Time frame: 42 days post delivery
Stillbirth rate
Time frame: Delivery
7-day neonatal mortality rate
Time frame: 7 days post delivery
28-day neonatal mortality rate
Time frame: 28 days post delivery
Rates of mothers transported to a referral hospital.
Time frame: 42 days post delivery
Rates of neonates/infants transported to a referral hospital
Time frame: 42 days post delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Derived from this study: PubMed 24090370Pasha O, McClure EM, Wright LL, Saleem S, Goudar SS, Chomba E, Patel A, Esamai F, Garces A, Althabe F, Kodkany B, Mabeya H, Manasyan A, Carlo WA, Derman RJ, Hibberd PL, Liechty EK, Krebs N, Hambidge KM, Buekens P, Moore J, Jobe AH, Koso-Thomas M, Wallace DD, Stalls S, Goldenberg RL; EMONC Trial Investigators. A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial. BMC Med. 2013 Oct 3;11:215. doi: 10.1186/1741-7015-11-215.
- Derived from this study: PubMed 21156060Pasha O, Goldenberg RL, McClure EM, Saleem S, Goudar SS, Althabe F, Patel A, Esamai F, Garces A, Chomba E, Mazariegos M, Kodkany B, Belizan JM, Derman RJ, Hibberd PL, Carlo WA, Liechty EA, Hambidge KM, Buekens P, Wallace D, Howard-Grabman L, Stalls S, Koso-Thomas M, Jobe AH, Wright LL. Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the Global Network's EmONC trial). BMC Pregnancy Childbirth. 2010 Dec 14;10:82. doi: 10.1186/1471-2393-10-82.
- The Global Network for Women's and Children's Health Research website contains information regarding the EmONC Trial, as well as other Global Network studies.Link provided by the sponsor.
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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.
Robert Goldenberg, MD principal investigator
Drexel University College of Medicine
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Mobilization, HBLSS and facility improvement in people with Maternal Morbidity and Mortality and Stillbirth and Neonatal Mortality, run by NICHD Global Network for Women's and Children's Health at 7 sites in 6 countries.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India, Argentina, Guatemala, Kenya, Pakistan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (time frame: 7 days post delivery). 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 NCT01073488, which also lists 2 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 18 Nov 2013.