Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

I. Gallos; A. Devall; J. Martin; L. Middleton; L. Beeson; H. Galadanci; F. Alwy Al-Beity; Z. Qureshi; G. J. Hofmeyr; N. Moran; S. Fawcus; L. Sheikh; G. Gwako; A. Osoti; A. Aswat; K. M. Mammoliti; K. N. Sindhu; M. Podesek; I. Horne; R. Timms; I. Yunas; J. Okore; M. Singata-Madliki; E. Arends; A. A. Wakili; A. Mwampashi; S. Nausheen; S. Muhammad; P. Latthe; C. Evans; S. Akter; G. Forbes; D. Lissauer; S. Meher; A. Weeks; A. Shennan; A. Ammerdorffer; E. Williams; T. Roberts; M. Widmer; O. T. Oladapo; F. Lorencatto; M. A. Bohren; S. Miller; F. Althabe; M. Gülmezoglu; J. M. Smith; K. Hemming; A. Coomarasamy

doi:10.1056/NEJMoa2303966

Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

I. Gallos, A. Devall (Lead / Corresponding author), J. Martin, L. Middleton, L. Beeson, H. Galadanci, F. Alwy Al-Beity, Z. Qureshi, G. J. Hofmeyr, N. Moran, S. Fawcus, L. Sheikh, G. Gwako, A. Osoti, A. Aswat, K. M. Mammoliti, K. N. Sindhu, M. Podesek, I. Horne, R. TimmsI. Yunas, J. Okore, M. Singata-Madliki, E. Arends, A. A. Wakili, A. Mwampashi, S. Nausheen, S. Muhammad, P. Latthe, C. Evans, S. Akter, G. Forbes, D. Lissauer, S. Meher, A. Weeks, A. Shennan, A. Ammerdorffer, E. Williams, T. Roberts, M. Widmer, O. T. Oladapo, F. Lorencatto, M. A. Bohren, S. Miller, F. Althabe, M. Gülmezoglu, J. M. Smith, K. Hemming, A. Coomarasamy

Health Sciences

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Abstract

Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.

Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.

Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).

Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery.

Original language	English
Pages (from-to)	11-21
Number of pages	11
Journal	New England Journal of Medicine
Volume	389
Issue number	1
Early online date	9 May 2023
DOIs	https://doi.org/10.1056/NEJMoa2303966
Publication status	Published - 6 Jul 2023

ASJC Scopus subject areas

Obstetrics and Gynaecology

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10.1056/NEJMoa2303966

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Gallos, I., Devall, A., Martin, J., Middleton, L., Beeson, L., Galadanci, H., Al-Beity, F. A., Qureshi, Z., Hofmeyr, G. J., Moran, N., Fawcus, S., Sheikh, L., Gwako, G., Osoti, A., Aswat, A., Mammoliti, K. M., Sindhu, K. N., Podesek, M., Horne, I., ... Coomarasamy, A. (2023). Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage. New England Journal of Medicine, 389(1), 11-21. https://doi.org/10.1056/NEJMoa2303966

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title = "Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage",

abstract = "Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. ",

author = "I. Gallos and A. Devall and J. Martin and L. Middleton and L. Beeson and H. Galadanci and Al-Beity, {F. Alwy} and Z. Qureshi and Hofmeyr, {G. J.} and N. Moran and S. Fawcus and L. Sheikh and G. Gwako and A. Osoti and A. Aswat and Mammoliti, {K. M.} and Sindhu, {K. N.} and M. Podesek and I. Horne and R. Timms and I. Yunas and J. Okore and M. Singata-Madliki and E. Arends and Wakili, {A. A.} and A. Mwampashi and S. Nausheen and S. Muhammad and P. Latthe and C. Evans and S. Akter and G. Forbes and D. Lissauer and S. Meher and A. Weeks and A. Shennan and A. Ammerdorffer and E. Williams and T. Roberts and M. Widmer and Oladapo, {O. T.} and F. Lorencatto and Bohren, {M. A.} and S. Miller and F. Althabe and M. G{\"u}lmezoglu and Smith, {J. M.} and K. Hemming and A. Coomarasamy",

year = "2023",

month = jul,

day = "6",

doi = "10.1056/NEJMoa2303966",

language = "English",

volume = "389",

pages = "11--21",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "1",

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Gallos, I, Devall, A, Martin, J, Middleton, L, Beeson, L, Galadanci, H, Al-Beity, FA, Qureshi, Z, Hofmeyr, GJ, Moran, N, Fawcus, S, Sheikh, L, Gwako, G, Osoti, A, Aswat, A, Mammoliti, KM, Sindhu, KN, Podesek, M, Horne, I, Timms, R, Yunas, I, Okore, J, Singata-Madliki, M, Arends, E, Wakili, AA, Mwampashi, A, Nausheen, S, Muhammad, S, Latthe, P, Evans, C, Akter, S, Forbes, G, Lissauer, D, Meher, S, Weeks, A, Shennan, A, Ammerdorffer, A, Williams, E, Roberts, T, Widmer, M, Oladapo, OT, Lorencatto, F, Bohren, MA, Miller, S, Althabe, F, Gülmezoglu, M, Smith, JM, Hemming, K & Coomarasamy, A 2023, 'Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage', New England Journal of Medicine, vol. 389, no. 1, pp. 11-21. https://doi.org/10.1056/NEJMoa2303966

TY - JOUR

T1 - Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

AU - Gallos, I.

AU - Devall, A.

AU - Martin, J.

AU - Middleton, L.

AU - Beeson, L.

AU - Galadanci, H.

AU - Al-Beity, F. Alwy

AU - Qureshi, Z.

AU - Hofmeyr, G. J.

AU - Moran, N.

AU - Fawcus, S.

AU - Sheikh, L.

AU - Gwako, G.

AU - Osoti, A.

AU - Aswat, A.

AU - Mammoliti, K. M.

AU - Sindhu, K. N.

AU - Podesek, M.

AU - Horne, I.

AU - Timms, R.

AU - Yunas, I.

AU - Okore, J.

AU - Singata-Madliki, M.

AU - Arends, E.

AU - Wakili, A. A.

AU - Mwampashi, A.

AU - Nausheen, S.

AU - Muhammad, S.

AU - Latthe, P.

AU - Evans, C.

AU - Akter, S.

AU - Forbes, G.

AU - Lissauer, D.

AU - Meher, S.

AU - Weeks, A.

AU - Shennan, A.

AU - Ammerdorffer, A.

AU - Williams, E.

AU - Roberts, T.

AU - Widmer, M.

AU - Oladapo, O. T.

AU - Lorencatto, F.

AU - Bohren, M. A.

AU - Miller, S.

AU - Althabe, F.

AU - Gülmezoglu, M.

AU - Smith, J. M.

AU - Hemming, K.

AU - Coomarasamy, A.

PY - 2023/7/6

Y1 - 2023/7/6

N2 - Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery.

AB - Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery.

U2 - 10.1056/NEJMoa2303966

DO - 10.1056/NEJMoa2303966

M3 - Comment/debate

C2 - 37158447

SN - 0028-4793

VL - 389

SP - 11

EP - 21

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 1

ER -

Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

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