Postpartum HemorrhageNCT03166839
Management of Postpartum Haemorrhage and Effect of Geographic Region
An observational study of Postpartum Hemorrhage, run by London School of Hygiene and Tropical Medicine.
Trial summary
Background: Maternal deaths occur universally and are largely avoidable. Postpartum haemorrhage accounts for a disproportionate amount of maternal deaths. There remains a great need to expeditiously decrease the rate of postpartum haemorrhage to prevent further mortality. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Experiencing PPH
- How many people
- 20,060 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to May 2017
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible adult women with a clinical diagnosis of postpartum haemorrhage following vaginal or caesarean section delivery will be included in this cohort analysis. While the diagnosis was clinical, a definition of postpartum haemorrhage could be based on clinically estimated blood loss of more than 500mL after vaginal birth or 1000mL after caesarean section or any blood loss sufficient to compromise haemodynamic stability.
Who may be able to join
- Women aged 16 years and older
- Clinical diagnosis of postpartum haemorrhage (PPH) after vaginal delivery or caesarean section
- "clinical uncertainty" about benefit of tranexamic acid in addition to routine management of PPH
Who cannot join
- Women aged 16 years and older with a clinical diagnosis of postpartum haemorrhage with clear indication or contra-indication for tranexamic acid
About this study
Official title: Management of Postpartum Haemorrhage and Effect of Geographic Region: A Secondary Analysis of the World Maternal Antifibrinolytic (WOMAN) Trial
Background: Maternal deaths occur universally and are largely avoidable. Postpartum haemorrhage accounts for a disproportionate amount of maternal deaths. There remains a great need to expeditiously decrease the rate of postpartum haemorrhage to prevent further mortality.
Methods: This study is a cohort analysis of data collected for the pragmatic international multi-centre randomized double blind placebo controlled design WOMAN Trial. It will present a univariate analysis of patient and delivery characteristics (age, type of delivery, placenta fully delivered, primary cause of haemorrhage, severity of haemorrhage), physiologic characteristics (systolic blood pressure, estimated blood loss, clinical signs of haemodynamic instability) and management characteristics (receipt of blood products, uterotonics). Multivariable logistic regression models and likelihood ratio tests will be used to examine the evidence for interaction between death from PPH and region after adjusting for any independent effects of 1) systolic blood pressure 2)age 3) type of delivery 4) receipt of blood products Discussion: This analysis of the WOMAN trial dataset will explore the relationship between geographical location, patient and environment characteristics and outcomes of postpartum haemorrhage. A protocol and statistical analysis plan is presented here.
Read the detailed description
Global burden of disease Maternal deaths occur universally and are largely avoidable(1). According to the first publication of the Maternal Health Series published in the Lancet October 2016, approximately 300,000 maternal deaths occurred in the past year. Postpartum haemorrhage was the cause of one tenth of these deaths(2,3). While this number has decreased globally since 1990, haemorrhage still accounts for a disproportionate amount of maternal deaths. There remains a great need to expeditiously decrease the rate of postpartum haemorrhage to prevent further mortality.
Why study postpartum haemorrhage? The most severe outcome of postpartum haemorrhage (PPH) is the death of a mother. The World Health Organization defines maternal death as "death of a woman while pregnant or within 42 days of termination of pregnancy" (4). The clinical definition of postpartum haemorrhage refers to more than 500mL of blood loss after a vaginal delivery and more than 1000mL after a caesarean section(5). Haemorrhage is a rapidly fatal condition, most commonly caused by uterine atony, or the inability of the uterus to contract, constricting the network of vessels in the uterine muscle, gradually slowing active bleeding. For this reason, research efforts have been directed at minimizing or preventing uterine atony through preventative or treatment measures targeted at the third stage of labour(6,7). Anti-fibrinolytics have been proposed as an alternative method of slowing bleeding and have been studied both as a prophylactic intervention and a treatment modality(8-11). Risk of death from postpartum haemorrhage increases if the woman is anaemic as she cannot tolerate blood loss to the same extent that her counterparts with normal haemoglobin levels can(3,12). Recent publication of preliminary findings of the woman trial suggest that the anti-fibrinolytic tranexamic acid may reduce maternal mortality from PPH by over one third(13).
Why stratify by region? While the absolute number of maternal deaths around the world is impressive, quoting a global rate does not accurately reflect the burden of illness in different regions of the world. In developed countries like the United States of America, the risk of dying from postpartum haemorrhage after delivering a live baby is 13.4% (pooled, range: 4.7-34.6). This stands in stark contrast to the African experience, where studies have documented maternal death rates from PPH to be as high as 33.9% (pooled, range: 13.3-43.5)(14). There are other reasons why these numbers can vary so broadly. An obvious hypothesis is that more women die from postpartum haemorrhage in developing countries than their counterparts in developed countries because it is more prevalent, more severe or is managed differently than in other parts of the world. It has been proposed, however, that the different rates in fact reflect a paucity of reliable data that is region specific. This is indeed the case when we look at the continent of Africa, where studies done to date capture only the experiences of eight of the 54 countries on the continent (Egypt in the North, Senegal in the West, and the Democratic Republic of Congo, South Africa, Tanzania, Zambia, Zimbabwe in the East and South)(14). A third factor in estimating deaths from postpartum haemorrhage reflects the different birthing environments across regions. In some countries, up to 50% of women deliver at home with support from a traditional birth attendant and never access a medical clinic or hospital. When most women do not deliver in a hospital or clinic, they do not die in a hospital or clinic so their data goes largely unregistered(9). Despite the fact that the "poorest countries have the poorest data"(12) enough is known about postpartum haemorrhage to inform action and spur further investigation, as many organizations have done(15).
While developing countries carry a higher burden of maternal deaths from postpartum haemorrhage, the impact of maternal death from PPH does not spare the developed world(14). Haemorrhage remains a leading cause of maternal death in countries where the majority of deliveries are performed in hospital with highly skilled support(16). This may be, in part, due to the unpredictability of postpartum haemorrhage, even in low-risk women(12). Risk factors for postpartum haemorrhage are commonly accepted to include previous postpartum haemorrhage, pre-eclampsia, disorders of the placenta, induction or augmentation of labour, perineal trauma, high birthweight and retained products(7)(16). Further, reporting occurrence of postpartum haemorrhage varies due to varying definitions of blood loss, the way blood loss is measured, intra-partum management strategies including uterotonics, uterine massage, and cord traction, interventions including method of delivery as well as the underlying characteristics of the population being studied(6)(3). Much time and resources have been invested in investigating the use of uretonics such as oxytocin to treat the most common causes of postpartum haemorrhage(7).
- Conditions
- Postpartum Hemorrhage
- Being tested
- Experiencing PPH
- Keywords
- maternal health, statistical analysis plan
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiencing PPHOther
No intervention given
| Study group | Role | What they receive |
|---|---|---|
| Region 1: Africa | Women living in and experiencing PPH in countries located in Africa. Receives: Other: Experiencing PPH | |
| Region 2: Asia | Women living in and experiencing PPH in countries located in Africa. Receives: Other: Experiencing PPH | |
| Region 3: Europe, NA, SA, Aus | Women living in and experiencing PPH in countries located in Africa. Receives: Other: Experiencing PPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death due to bleeding from PPH
Measured: Within 42 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startMar 2009
- Primary completionJun 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Roberts, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166839
- Sponsor's protocol ID
- 12049
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graham W, Woodd S, Byass P, Filippi V, Gon G, Virgo S, Chou D, Hounton S, Lozano R, Pattinson R, Singh S. Diversity and divergence: the dynamic burden of poor maternal health. Lancet. 2016 Oct 29;388(10056):2164-2175. doi: 10.1016/S0140-6736(16)31533-1. Epub 2016 Sep 16.
PubMed 27642022Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V. Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012;7(7):e41114. doi: 10.1371/journal.pone.0041114. Epub 2012 Jul 23.
PubMed 22844432Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25.
PubMed 18819848Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4.
PubMed 25730178Mousa HA, Blum J, Abou El Senoun G, Shakur H, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev. 2014 Feb 13;2014(2):CD003249. doi: 10.1002/14651858.CD003249.pub3.
PubMed 24523225Shakur H, Roberts I, Edwards P, Elbourne D, Alfirevic Z, Ronsmans C. The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial. Trials. 2016 May 17;17(1):249. doi: 10.1186/s13063-016-1332-2.
PubMed 27188698McClure EM, Jones B, Rouse DJ, Griffin JB, Kamath-Rayne BD, Downs A, Goldenberg RL. Tranexamic acid to reduce postpartum hemorrhage: A MANDATE systematic review and analyses of impact on maternal mortality. Am J Perinatol. 2015 Apr;32(5):469-74. doi: 10.1055/s-0034-1390347. Epub 2014 Oct 7.
PubMed 25289705Gohel, M Efficacy of tranexemic acid in decreasing blood loss during and after cesarean section: A randomised case controlled prospective study. J Obstet Gynecol India. 2007;57(3):227-30.
Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3.
PubMed 26079202Mousa HA, Cording V, Alfirevic Z. Risk factors and interventions associated with major primary postpartum hemorrhage unresponsive to first-line conventional therapy. Acta Obstet Gynecol Scand. 2008;87(6):652-61. doi: 10.1080/00016340802087660.
PubMed 18568465Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
PubMed 16581405Ronsmans C, Graham WJ; Lancet Maternal Survival Series steering group. Maternal mortality: who, when, where, and why. Lancet. 2006 Sep 30;368(9542):1189-200. doi: 10.1016/S0140-6736(06)69380-X.
PubMed 17011946WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
PubMed 28456509
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Postpartum Haemorrhage and Effect of Geographic Region: A Secondary Analysis of the World Maternal Antifibrinolytic (WOMAN) Trial
- ClinicalTrials.gov ID
- NCT03166839
- Acronym / sponsor ID
- 12049
- Conditions
- Postpartum Hemorrhage
- Keywords
- maternal health, statistical analysis plan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,060 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 May 2017 (actual)
- 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: Maternal deaths occur universally and are largely avoidable. Postpartum haemorrhage accounts for a disproportionate amount of maternal deaths. There remains a great need to expeditiously decrease the rate of postpartum haemorrhage to prevent further mortality.
Methods: This study is a cohort analysis of data collected for the pragmatic international multi-centre randomized double blind placebo controlled design WOMAN Trial. It will present a univariate analysis of patient and delivery characteristics (age, type of delivery, placenta fully delivered, primary cause of haemorrhage, severity of haemorrhage), physiologic characteristics (systolic blood pressure, estimated blood loss, clinical signs of haemodynamic instability) and management characteristics (receipt of blood products, uterotonics). Multivariable logistic regression models and likelihood ratio tests will be used to examine the evidence for interaction between death from PPH and region after adjusting for any independent effects of 1) systolic blood pressure 2)age 3) type of delivery 4) receipt of blood products Discussion: This analysis of the WOMAN trial dataset will explore the relationship between geographical location, patient and environment characteristics and outcomes of postpartum haemorrhage. A protocol and statistical analysis plan is presented here.
Detailed description
Global burden of disease Maternal deaths occur universally and are largely avoidable(1). According to the first publication of the Maternal Health Series published in the Lancet October 2016, approximately 300,000 maternal deaths occurred in the past year. Postpartum haemorrhage was the cause of one tenth of these deaths(2,3). While this number has decreased globally since 1990, haemorrhage still accounts for a disproportionate amount of maternal deaths. There remains a great need to expeditiously decrease the rate of postpartum haemorrhage to prevent further mortality.
Why study postpartum haemorrhage? The most severe outcome of postpartum haemorrhage (PPH) is the death of a mother. The World Health Organization defines maternal death as "death of a woman while pregnant or within 42 days of termination of pregnancy" (4). The clinical definition of postpartum haemorrhage refers to more than 500mL of blood loss after a vaginal delivery and more than 1000mL after a caesarean section(5). Haemorrhage is a rapidly fatal condition, most commonly caused by uterine atony, or the inability of the uterus to contract, constricting the network of vessels in the uterine muscle, gradually slowing active bleeding. For this reason, research efforts have been directed at minimizing or preventing uterine atony through preventative or treatment measures targeted at the third stage of labour(6,7). Anti-fibrinolytics have been proposed as an alternative method of slowing bleeding and have been studied both as a prophylactic intervention and a treatment modality(8-11). Risk of death from postpartum haemorrhage increases if the woman is anaemic as she cannot tolerate blood loss to the same extent that her counterparts with normal haemoglobin levels can(3,12). Recent publication of preliminary findings of the woman trial suggest that the anti-fibrinolytic tranexamic acid may reduce maternal mortality from PPH by over one third(13).
Why stratify by region? While the absolute number of maternal deaths around the world is impressive, quoting a global rate does not accurately reflect the burden of illness in different regions of the world. In developed countries like the United States of America, the risk of dying from postpartum haemorrhage after delivering a live baby is 13.4% (pooled, range: 4.7-34.6). This stands in stark contrast to the African experience, where studies have documented maternal death rates from PPH to be as high as 33.9% (pooled, range: 13.3-43.5)(14). There are other reasons why these numbers can vary so broadly. An obvious hypothesis is that more women die from postpartum haemorrhage in developing countries than their counterparts in developed countries because it is more prevalent, more severe or is managed differently than in other parts of the world. It has been proposed, however, that the different rates in fact reflect a paucity of reliable data that is region specific. This is indeed the case when we look at the continent of Africa, where studies done to date capture only the experiences of eight of the 54 countries on the continent (Egypt in the North, Senegal in the West, and the Democratic Republic of Congo, South Africa, Tanzania, Zambia, Zimbabwe in the East and South)(14). A third factor in estimating deaths from postpartum haemorrhage reflects the different birthing environments across regions. In some countries, up to 50% of women deliver at home with support from a traditional birth attendant and never access a medical clinic or hospital. When most women do not deliver in a hospital or clinic, they do not die in a hospital or clinic so their data goes largely unregistered(9). Despite the fact that the "poorest countries have the poorest data"(12) enough is known about postpartum haemorrhage to inform action and spur further investigation, as many organizations have done(15).
While developing countries carry a higher burden of maternal deaths from postpartum haemorrhage, the impact of maternal death from PPH does not spare the developed world(14). Haemorrhage remains a leading cause of maternal death in countries where the majority of deliveries are performed in hospital with highly skilled support(16). This may be, in part, due to the unpredictability of postpartum haemorrhage, even in low-risk women(12). Risk factors for postpartum haemorrhage are commonly accepted to include previous postpartum haemorrhage, pre-eclampsia, disorders of the placenta, induction or augmentation of labour, perineal trauma, high birthweight and retained products(7)(16). Further, reporting occurrence of postpartum haemorrhage varies due to varying definitions of blood loss, the way blood loss is measured, intra-partum management strategies including uterotonics, uterine massage, and cord traction, interventions including method of delivery as well as the underlying characteristics of the population being studied(6)(3). Much time and resources have been invested in investigating the use of uretonics such as oxytocin to treat the most common causes of postpartum haemorrhage(7).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Region 1: Africa | – | Other: Experiencing PPHWomen living in and experiencing PPH in countries located in Africa. |
| Region 2: Asia | – | Other: Experiencing PPHWomen living in and experiencing PPH in countries located in Africa. |
| Region 3: Europe, NA, SA, Aus | – | Other: Experiencing PPHWomen living in and experiencing PPH in countries located in Africa. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible adult women with a clinical diagnosis of postpartum haemorrhage following vaginal or caesarean section delivery will be included in this cohort analysis. While the diagnosis was clinical, a definition of postpartum haemorrhage could be based on clinically estimated blood loss of more than 500mL after vaginal birth or 1000mL after caesarean section or any blood loss sufficient to compromise haemodynamic stability.
Key inclusion criteria (3 listed)
- Women aged 16 years and older
- Clinical diagnosis of postpartum haemorrhage (PPH) after vaginal delivery or caesarean section
- "clinical uncertainty" about benefit of tranexamic acid in addition to routine management of PPH
Key exclusion criteria (1 listed)
- Women aged 16 years and older with a clinical diagnosis of postpartum haemorrhage with clear indication or contra-indication for tranexamic acid
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 |
|---|---|---|
| Experiencing PPHNo intervention given | Other | Region 1: Africa, Region 2: Asia, Region 3: Europe, NA, SA, Aus |
Primary outcome
Death
Time frame: Within 42 days of delivery
Death due to bleeding from PPH
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 30 May 2017.
- Background: PubMed 27642022Graham W, Woodd S, Byass P, Filippi V, Gon G, Virgo S, Chou D, Hounton S, Lozano R, Pattinson R, Singh S. Diversity and divergence: the dynamic burden of poor maternal health. Lancet. 2016 Oct 29;388(10056):2164-2175. doi: 10.1016/S0140-6736(16)31533-1. Epub 2016 Sep 16.
- Background: PubMed 22844432Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V. Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012;7(7):e41114. doi: 10.1371/journal.pone.0041114. Epub 2012 Jul 23.
- Background: PubMed 18819848Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25.
- Background: PubMed 25730178Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4.
- Background: PubMed 24523225Mousa HA, Blum J, Abou El Senoun G, Shakur H, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev. 2014 Feb 13;2014(2):CD003249. doi: 10.1002/14651858.CD003249.pub3.
- Background: PubMed 27188698Shakur H, Roberts I, Edwards P, Elbourne D, Alfirevic Z, Ronsmans C. The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial. Trials. 2016 May 17;17(1):249. doi: 10.1186/s13063-016-1332-2.
- Background: PubMed 25289705McClure EM, Jones B, Rouse DJ, Griffin JB, Kamath-Rayne BD, Downs A, Goldenberg RL. Tranexamic acid to reduce postpartum hemorrhage: A MANDATE systematic review and analyses of impact on maternal mortality. Am J Perinatol. 2015 Apr;32(5):469-74. doi: 10.1055/s-0034-1390347. Epub 2014 Oct 7.
- BackgroundGohel, M Efficacy of tranexemic acid in decreasing blood loss during and after cesarean section: A randomised case controlled prospective study. J Obstet Gynecol India. 2007;57(3):227-30.
- Background: PubMed 26079202Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3.
- Background: PubMed 18568465Mousa HA, Cording V, Alfirevic Z. Risk factors and interventions associated with major primary postpartum hemorrhage unresponsive to first-line conventional therapy. Acta Obstet Gynecol Scand. 2008;87(6):652-61. doi: 10.1080/00016340802087660.
- Background: PubMed 16581405Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
- Background: PubMed 17011946Ronsmans C, Graham WJ; Lancet Maternal Survival Series steering group. Maternal mortality: who, when, where, and why. Lancet. 2006 Sep 30;368(9542):1189-200. doi: 10.1016/S0140-6736(06)69380-X.
- Individual participant dataSharing planned: No
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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.
Ian Roberts principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by London School of Hygiene and Tropical Medicine.
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 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 30 May 2017. 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?
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?
Death (time frame: Within 42 days of 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 NCT03166839, which also lists 13 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 30 May 2017.