Preterm BirthACTNCT01084096
Trial of the Use of Antenatal Corticosteroids in Developing Countries
A study testing Increasing use of Antenatal Corticosteroids (ACS) in people with Preterm Birth, run by NICHD Global Network for Women's and Children's Health at 7 sites in 6 countries.
Trial summary
Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Increasing use of Antenatal Corticosteroids (ACS)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103,117 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- There will not be any specific exclusion criteria for clusters or participants.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Argentina1 site
Institute for Clinical Effectiveness and Health Policy (IECS)
Buenos Aires
Guatemala1 site
Universidad Francisco Marroquin Facultad de Medicina
Guatemala City
About this study
Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.
Read the detailed description
One of the United Nations Millennium Summit goals is to reduce the deaths of children <5 years by two-thirds for 2015 (UN, 2000). Given that 38% of all under-five deaths worldwide occur in the first four weeks of life, the goal seems unattainable unless a significant fraction of the neonatal deaths are prevented (Darmstadt et al., 2005). Thus, the provision of health care during the perinatal period in developing countries is a top priority. Preterm birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. One of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth.
The primary objective will be to evaluate whether a cluster-level multifaceted intervention, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, reduces neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six African, Asian, and Latin American countries.
- Conditions
- Preterm Birth
- Being tested
- Increasing use of Antenatal Corticosteroids (ACS)
- Keywords
- Antenatal Corticosteroids, Preterm Birth, Diffusion
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing use of Antenatal Corticosteroids (ACS)Behavioural
Also called Four 6 mg doses of dexamethasone
Intervention clusters:
- Increasing administration of ACS to pregnant women at high risk of preterm birth (HRPB) by providing health providers with kits containing dexamethasone, syringes, and instructions. Eligible women receive four injections of 6 mg dexamethasone from the kit or regimen of choice at the site.
- Improving identification of women at HRPB by diffusing recommendations for ACS use to health care providers, training health care providers to identify signs of preterm labor and eligibility criteria for ACS use, providing reminders to healthcare providers on the use of the kits, and using a color-coded tape to measure uterine height to estimate gestational age in women at HRPB with unknown gestational age.
Control clusters: no specific intervention for comparison. Both intervention and control clusters: Birth attendants trained in essential newborn care of LBW infants and instructed to teach mothers how to provide care to premature infants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Eligible women at high risk for preterm birth will be identified and four 6 mg doses of dexamethasone will be administered before delivery. Receives: Behavioral: Increasing use of Antenatal Corticosteroids (ACS) |
| Control | No intervention | Control arm will not receive a specific intervention for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity)
Neonatal deaths before 28 days per 1,000 live births among <5th %tile birth weight infants. The <5th %tile birth weight group was a proxy for preterm. Site-specific cutoffs from pretrial data were 2,450g-Argentina, 2,400g-Zambia, 2,267g-Guatemala, 2,000g-Belgaum, India, 2,150g-Pakistan, 2,000g-Nagpur, India, and 2,500g-Kenya. Infants were classified as <5th %tile on the basis of measured birth weights. Estimated weights by clinical assessment were used when measured weights were unavailable; those missing weights were classified as <5th %tile (since based on historical data, most of the missing data were for preterm infants). We used birth weight rather than gestational age (GA) for the primary analysis subgroup because many women in the registry had missing or uncertain GA, ultrasound was often unavailable, and the intervention was designed to improve estimation of GA, which could potentially bias GA-based analyses. All live births, including multiple births, are included.
Measured: Birth to 28 days
Secondary outcomes (5)
Use of Antenatal Corticosteroids in Women at Risk of Preterm Birth in All the Study Clusters
Antenatal corticosteroids provided antepartum assessed in women with a less-than-5th-percentile for birth weight infants. Site-specific cut offs were determined from pretrial data.
Measured: 48 hours after identification of risk for preterm birth
Suspected Maternal Infection
Maternal safety was assessed through the frequency of suspected maternal infection, a composite of process outcomes including receipt of antibiotics plus hospital admission or referral, and receipt of intravenous fluids, surgery, or other treatment related to infection. The definition also included evidence of antepartum or post-partum infection for mothers with infants with a birthweight less than 2500 g. Additionally, use of antenatal corticosteroids, neonatal and perinatal mortality, and suspected maternal infection were measured for all births, irrespective of birthweight.
Measured: Pregnancy through 6 weeks postpartum
Maternal Mortality Rate
The denominator for maternal deaths through 42 days is pregnancy ending in live birth + all maternal deaths. Maternal mortality includes all maternal deaths through 42 days postpartum, irrespective of cause.
Measured: Pregnancy through 42 days postpartum
Neonatal Mortality Rate
Number of neonatal deaths before 28 days per 1,000 live births
Measured: Birth to 28 days
Stillbirth Mortality Rate
Number of stillbirths per 1,000 births
Measured: 20 weeks' gestational age to birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- RTI International, Tulane University School of Medicine, Institute for Clinical Effectiveness and Health Policy, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Universidad Francisco Marroquín, Jawaharlal Nehru Medical College, Christiana Care Health Services, Aga Khan University, Columbia University, Indiana University, Moi Univeristy, Lata Medical Research Foundation, Nagpur, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Fernando Althabe, M.D., Principal investigator, Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084096
- Sponsor's protocol ID
- GN ACT Study
- Acronym
- ACT
- Status last verified
- Oct 2024
- First submitted
- 9 Mar 2010
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McGoldrick E, Stewart F, Parker R, Dalziel SR. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2020 Dec 25;12(12):CD004454. doi: 10.1002/14651858.CD004454.pub4.
PubMed 33368142Rohwer AC, Oladapo OT, Hofmeyr GJ. Strategies for optimising antenatal corticosteroid administration for women with anticipated preterm birth. Cochrane Database Syst Rev. 2020 May 26;5(5):CD013633. doi: 10.1002/14651858.CD013633.
PubMed 32452555Patel A, Prakash AA, Pusdekar YV, Kulkarni H, Hibberd P. Detection and risk stratification of women at high risk of preterm birth in rural communities near Nagpur, India. BMC Pregnancy Childbirth. 2017 Sep 19;17(1):311. doi: 10.1186/s12884-017-1504-4.
PubMed 28927395Goldenberg RL, Thorsten VR, Althabe F, Saleem S, Garces A, Carlo WA, Pasha O, Chomba E, Goudar S, Esamai F, Krebs NF, Derman RJ, Liechty EA, Patel A, Hibberd PL, Buekens PM, Koso-Thomas M, Miodovnik M, Jobe AH, Wallace DD, Belizan JM, McClure EM. The global network antenatal corticosteroids trial: impact on stillbirth. Reprod Health. 2016 Jun 2;13(1):68. doi: 10.1186/s12978-016-0174-4.
PubMed 27255082Berrueta M, Hemingway-Foday J, Thorsten VR, Goldenberg RL, Carlo WA, Garces A, Patel A, Saleem S, Pasha O, Chomba E, Hibberd PL, Krebs NF, Goudar S, Derman RJ, Esamai F, Liechty EA, Moore JL, McClure EM, Koso-Thomas M, Buekens PM, Belizan JM, Althabe F. Use of antenatal corticosteroids at health facilities and communities in low-and-middle income countries. Reprod Health. 2016 May 27;13(1):66. doi: 10.1186/s12978-016-0176-2.
PubMed 27228986Klein K, McClure EM, Colaci D, Thorsten V, Hibberd PL, Esamai F, Garces A, Patel A, Saleem S, Pasha O, Chomba E, Carlo WA, Krebs NF, Goudar S, Derman RJ, Liechty EA, Koso-Thomas M, Buekens PM, Belizan JM, Goldenberg RL, Althabe F. The Antenatal Corticosteroids Trial (ACT): a secondary analysis to explore site differences in a multi-country trial. Reprod Health. 2016 May 24;13(1):64. doi: 10.1186/s12978-016-0179-z.
PubMed 27221319Garces A, McClure EM, Figueroa L, Pineda S, Hambidge KM, Krebs NF, Thorsten VR, Wallace DD, Althabe F, Goldenberg RL. A multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth: a case study from the Guatemalan Western Highlands. Reprod Health. 2016 May 24;13(1):63. doi: 10.1186/s12978-016-0178-0.
PubMed 27221237Althabe F, Belizan JM, McClure EM, Hemingway-Foday J, Berrueta M, Mazzoni A, Ciganda A, Goudar SS, Kodkany BS, Mahantshetti NS, Dhaded SM, Katageri GM, Metgud MC, Joshi AM, Bellad MB, Honnungar NV, Derman RJ, Saleem S, Pasha O, Ali S, Hasnain F, Goldenberg RL, Esamai F, Nyongesa P, Ayunga S, Liechty EA, Garces AL, Figueroa L, Hambidge KM, Krebs NF, Patel A, Bhandarkar A, Waikar M, Hibberd PL, Chomba E, Carlo WA, Mwiche A, Chiwila M, Manasyan A, Pineda S, Meleth S, Thorsten V, Stolka K, Wallace DD, Koso-Thomas M, Jobe AH, Buekens PM. A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial. Lancet. 2015 Feb 14;385(9968):629-639. doi: 10.1016/S0140-6736(14)61651-2. Epub 2014 Oct 15.
PubMed 25458726Althabe F, Belizan JM, Mazzoni A, Berrueta M, Hemingway-Foday J, Koso-Thomas M, McClure E, Chomba E, Garces A, Goudar S, Kodkany B, Saleem S, Pasha O, Patel A, Esamai F, Carlo WA, Krebs NF, Derman RJ, Goldenberg RL, Hibberd P, Liechty EA, Wright LL, Bergel EF, Jobe AH, Buekens P. Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol. Reprod Health. 2012 Sep 19;9:22. doi: 10.1186/1742-4755-9-22.
PubMed 22992312
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of the Use of Antenatal Corticosteroids in Developing Countries
- ClinicalTrials.gov ID
- NCT01084096
- Acronym / sponsor ID
- ACT / GN ACT Study
- Conditions
- Preterm Birth
- Keywords
- Antenatal Corticosteroids, Preterm Birth, Diffusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103,117 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- RTI International, Tulane University School of Medicine, Institute for Clinical Effectiveness and Health Policy, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia, University of Colorado, Denver, Universidad Francisco Marroquín, Jawaharlal Nehru Medical College, Christiana Care Health Services, Aga Khan University, Columbia University, Indiana University, Moi Univeristy, Lata Medical Research Foundation, Nagpur, Massachusetts General Hospital
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.
Detailed description
One of the United Nations Millennium Summit goals is to reduce the deaths of children <5 years by two-thirds for 2015 (UN, 2000). Given that 38% of all under-five deaths worldwide occur in the first four weeks of life, the goal seems unattainable unless a significant fraction of the neonatal deaths are prevented (Darmstadt et al., 2005). Thus, the provision of health care during the perinatal period in developing countries is a top priority. Preterm birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. One of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth.
The primary objective will be to evaluate whether a cluster-level multifaceted intervention, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, reduces neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six African, Asian, and Latin American countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Increasing use of Antenatal Corticosteroids (ACS)Eligible women at high risk for preterm birth will be identified and four 6 mg doses of dexamethasone will be administered before delivery. |
| Control | No intervention | –Control arm will not receive a specific intervention for comparison. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- There will not be any specific exclusion criteria for clusters or participants.
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 |
|---|---|---|
| Increasing use of Antenatal Corticosteroids (ACS)Also: Four 6 mg doses of dexamethasoneIntervention clusters: * Increasing administration of ACS to pregnant women at high risk of preterm birth (HRPB) by providing health providers with kits containing dexamethasone, syringes, and instructions. Eligible women receive four injections of 6 mg dexamethasone from the kit or regimen of choice at the site. * Improving identification of women at HRPB by diffusing recommendations for ACS use to health care providers, training health care providers to identify signs of preterm labor and eligibility criteria for ACS use, providing reminders to healthcare providers on the use of the kits, and using a color-coded tape to measure uterine height to estimate gestational age in women at HRPB with unknown gestational age. Control clusters: no specific intervention for comparison. Both intervention and control clusters: Birth attendants trained in essential newborn care of LBW infants and instructed to teach mothers how to provide care to premature infants. | Behavioural | Intervention |
Primary outcome
Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity)
Time frame: Birth to 28 days
Neonatal deaths before 28 days per 1,000 live births among <5th %tile birth weight infants. The <5th %tile birth weight group was a proxy for preterm. Site-specific cutoffs from pretrial data were 2,450g-Argentina, 2,400g-Zambia, 2,267g-Guatemala, 2,000g-Belgaum, India, 2,150g-Pakistan, 2,000g-Nagpur, India, and 2,500g-Kenya. Infants were classified as <5th %tile on the basis of measured birth weights. Estimated weights by clinical assessment were used when measured weights were unavailable; those missing weights were classified as <5th %tile (since based on historical data, most of the missing data were for preterm infants). We used birth weight rather than gestational age (GA) for the primary analysis subgroup because many women in the registry had missing or uncertain GA, ultrasound was often unavailable, and the intervention was designed to improve estimation of GA, which could potentially bias GA-based analyses. All live births, including multiple births, are included.
5 secondary outcomes
Use of Antenatal Corticosteroids in Women at Risk of Preterm Birth in All the Study Clusters
Time frame: 48 hours after identification of risk for preterm birth
Suspected Maternal Infection
Time frame: Pregnancy through 6 weeks postpartum
Maternal Mortality Rate
Time frame: Pregnancy through 42 days postpartum
Neonatal Mortality Rate
Time frame: Birth to 28 days
Stillbirth Mortality Rate
Time frame: 20 weeks' gestational age to birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33368142McGoldrick E, Stewart F, Parker R, Dalziel SR. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2020 Dec 25;12(12):CD004454. doi: 10.1002/14651858.CD004454.pub4.
- Derived from this study: PubMed 32452555Rohwer AC, Oladapo OT, Hofmeyr GJ. Strategies for optimising antenatal corticosteroid administration for women with anticipated preterm birth. Cochrane Database Syst Rev. 2020 May 26;5(5):CD013633. doi: 10.1002/14651858.CD013633.
- Derived from this study: PubMed 28927395Patel A, Prakash AA, Pusdekar YV, Kulkarni H, Hibberd P. Detection and risk stratification of women at high risk of preterm birth in rural communities near Nagpur, India. BMC Pregnancy Childbirth. 2017 Sep 19;17(1):311. doi: 10.1186/s12884-017-1504-4.
- Derived from this study: PubMed 27255082Goldenberg RL, Thorsten VR, Althabe F, Saleem S, Garces A, Carlo WA, Pasha O, Chomba E, Goudar S, Esamai F, Krebs NF, Derman RJ, Liechty EA, Patel A, Hibberd PL, Buekens PM, Koso-Thomas M, Miodovnik M, Jobe AH, Wallace DD, Belizan JM, McClure EM. The global network antenatal corticosteroids trial: impact on stillbirth. Reprod Health. 2016 Jun 2;13(1):68. doi: 10.1186/s12978-016-0174-4.
- Derived from this study: PubMed 27228986Berrueta M, Hemingway-Foday J, Thorsten VR, Goldenberg RL, Carlo WA, Garces A, Patel A, Saleem S, Pasha O, Chomba E, Hibberd PL, Krebs NF, Goudar S, Derman RJ, Esamai F, Liechty EA, Moore JL, McClure EM, Koso-Thomas M, Buekens PM, Belizan JM, Althabe F. Use of antenatal corticosteroids at health facilities and communities in low-and-middle income countries. Reprod Health. 2016 May 27;13(1):66. doi: 10.1186/s12978-016-0176-2.
- Derived from this study: PubMed 27221319Klein K, McClure EM, Colaci D, Thorsten V, Hibberd PL, Esamai F, Garces A, Patel A, Saleem S, Pasha O, Chomba E, Carlo WA, Krebs NF, Goudar S, Derman RJ, Liechty EA, Koso-Thomas M, Buekens PM, Belizan JM, Goldenberg RL, Althabe F. The Antenatal Corticosteroids Trial (ACT): a secondary analysis to explore site differences in a multi-country trial. Reprod Health. 2016 May 24;13(1):64. doi: 10.1186/s12978-016-0179-z.
- Derived from this study: PubMed 27221237Garces A, McClure EM, Figueroa L, Pineda S, Hambidge KM, Krebs NF, Thorsten VR, Wallace DD, Althabe F, Goldenberg RL. A multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth: a case study from the Guatemalan Western Highlands. Reprod Health. 2016 May 24;13(1):63. doi: 10.1186/s12978-016-0178-0.
- Derived from this study: PubMed 25458726Althabe F, Belizan JM, McClure EM, Hemingway-Foday J, Berrueta M, Mazzoni A, Ciganda A, Goudar SS, Kodkany BS, Mahantshetti NS, Dhaded SM, Katageri GM, Metgud MC, Joshi AM, Bellad MB, Honnungar NV, Derman RJ, Saleem S, Pasha O, Ali S, Hasnain F, Goldenberg RL, Esamai F, Nyongesa P, Ayunga S, Liechty EA, Garces AL, Figueroa L, Hambidge KM, Krebs NF, Patel A, Bhandarkar A, Waikar M, Hibberd PL, Chomba E, Carlo WA, Mwiche A, Chiwila M, Manasyan A, Pineda S, Meleth S, Thorsten V, Stolka K, Wallace DD, Koso-Thomas M, Jobe AH, Buekens PM. A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial. Lancet. 2015 Feb 14;385(9968):629-639. doi: 10.1016/S0140-6736(14)61651-2. Epub 2014 Oct 15.
- Derived from this study: PubMed 22992312Althabe F, Belizan JM, Mazzoni A, Berrueta M, Hemingway-Foday J, Koso-Thomas M, McClure E, Chomba E, Garces A, Goudar S, Kodkany B, Saleem S, Pasha O, Patel A, Esamai F, Carlo WA, Krebs NF, Derman RJ, Goldenberg RL, Hibberd P, Liechty EA, Wright LL, Bergel EF, Jobe AH, Buekens P. Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol. Reprod Health. 2012 Sep 19;9:22. doi: 10.1186/1742-4755-9-22.
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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.
Fernando Althabe, M.D. principal investigator
Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing use of Antenatal Corticosteroids (ACS) in people with Preterm Birth, 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 0 inclusion and 1 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 9 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (time frame: Birth to 28 days). 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 NCT01084096, which also lists 9 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 9 Dec 2024.