Letters to the Editor Uterine Massage to Reduce Blood Loss After Vaginal Delivery: A Randomized Controlled Trial To the Editor: I read with interest the article by Chen et al.1 Postpartum hemorrhage is indeed a serious complication of labor all over the world. Postpartum hemorrhage needs to be dealt with promptly, efficiently, and comprehensively. Because there are many different causes, the management cannot be simplified to one-protocol-fits-all. The authors’ protocol was fit for a low-resources set-up indeed—administer 10 international units of oxytocin intramuscularly and observe compared with same and massage the uterus for 30 minutes. The primary outcome of more than 400 mL of blood loss in 2 hours in only 12% of parturients is excellent; I always thought that 500 mL is probably an underestimated average. The average blood loss of 260 mL in patients not needing any further attention highlights the success of the implementation of evidence-based medicine recommendations.2 The secondary outcome of postpartum hemorrhage of 0.4–0.5% is also excellent in both arms. The 1:5 need for secondary intervention highlights the seriousness of postpartum hemorrhage. This group of patients, the 17.9–19% of patients requiring therapeutic oxytocics, should have been the subject of investiLetters to the Editor Guidelines. Letters posing a question or challenge to an article appearing in Obstetrics & Gynecology should be submitted within 6 weeks of the article’s publication online. Letters received after 6 weeks will rarely be considered. Letters should not exceed 350 words, including signatures and 5 references. A word count should be provided. The maximum number of authors permitted is four, and a corresponding author should be designated (and contact information listed). Letters will be published at the discretion of the Editor. The Editor may send the letter to the authors of the original paper so their comments may be published simultaneously. The Editor reserves the right to edit and shorten letters. A signed author agreement form is required from all authors before publication. Letters should be submitted using the Obstetrics & Gynecology online submission and review system, Editorial Manager (http://ong.edmgr.com).
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gation. They should have been randomized in the first place to therapeutic oxytocics with or without massage. Massaging the uterus for half an hour in more than 900 patients, 77% of the study group, who did not need it is indeed a waste of time and personnel in any obstetric setting, even more so in a lowresources setting. The group should have been treated according to World Health Organization recommendations3: inspect the placenta and, if complete, observe the bleeding pattern and monitor vital signs and uterine fundus. Those needing therapeutic intervention should have been randomized to therapeutic oxytocic alone or uterine massage and oxytocic. Further, monitor the bleeding, apply secondary intervention where and when needed, and then analyze the two groups. I would agree with the authors that, if there is no excessive bleeding, there is no need to deliver the placenta actively.4 The same should have been applied to their population—if there is no need for secondary oxytocics, exclude patients from a postpartum hemorrhage trial before testing a hypothesis. This study was conducted in a correct manner, and the ethical requirements were fulfilled. It is great to see leadership in having a national clinical trial registry. The randomization, exclusion and inclusion criteria, even the measure of the primary and secondary outcomes, were correct. The statistics appear reasonable. The population selected for randomized was, however, wrong. Although this study was level-one evidence, it highlights the pitfalls of evidence-based medicine. We have seen it with the Women’s Health Initiative trial.5,6 After reading and analyzing this publication, I would think that the conclusions of this study cannot be accepted as factual or evidence-based. Focused studies are needed before a simple, cheap, and often effective, even life-saving, procedure in any resource setting is discarded. I did experience it, and I am convinced that, when dealing with an atonic uterus when oxytocics are not working, uterine massage, just like the tension suture at the time of cesarean delivery, could give us the time needed to perform other, more aggressive interventions. Financial Disclosure: The author did not report any potential conflicts of interest.
Emeric P. Fröhlich,
FCOG (SA), FRCOG (London)
Sunninghill Hospital, Johannesburg, South Africa
REFERENCES 1. Chen M, Chang Q, Duan T, He J, Zhang L, Liu X. Uterine massage to reduce blood loss after vaginal delivery: a randomized controlled trial. Obstet Gynecol 2013;122:290–5. 2. Etbourne DR, Prendiville WJ, Carroli G, Wood J, McDonald S. Prophylactic oxytocin for the third stage of labour. The Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD001808. DOI: 10.1002/14651858.CD001808. 3. WHO recommendations for the prevention of postpartum hemorrhage. Available at: http://www.afro.who.int/index.php? option5com_docman&task5doc_download &gid53210. Retrieved October 28, 2013. 4. Gülmezoglu AM, Lumbiganon P, Landoulsi S, Widmer M, AbdelAleem H, Festin M, et al. Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial. Lancet 2012;379:1721–7. 5. Pines A. WHI and aftermath: looking beyond the figures. Maturitas 2005;51: 48–50. 6. Ostrzenski A, Ostrzenska KM. WHI clinical trial revisited: imprecise scientific methodology disqualifies the study outcomes. Obstet Gynecol 2005;193:1599–604.
In Reply: We thank Dr. Fröhlich for his interest in our recent publication pertaining to the effectiveness of routine uterine massage to reduce blood loss after vaginal delivery.1 The raised question is whether those women needing therapeutic oxytocics in our study should have been randomized to therapeutic oxytocic alone or to uterine massage plus therapeutic oxytocic. In our study, we indeed tried to assess the effectiveness of routine uterine massage as a preventative strategy for postpartum hemorrhage and found that this did not provide additional benefit when oxytocin was administered prophylactically. As with many other large trials investigating postpartum hemorrhage prevention,2,3 the use of therapeutic oxytocic was regarded as a secondary outcome rather than an inclusion criterion
OBSTETRICS & GYNECOLOGY
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gation. They should have been randomized in the first place to therapeutic oxytocics with or without massage. Massaging the uterus for half an hour in more than 900 patients, 77% of the study group, who did not need it is indeed a waste of time and personnel in any obstetric setting, even more so in a lowresources setting. The group should have been treated according to World Health Organization recommendations3: inspect the placenta and, if complete, observe the bleeding pattern and monitor vital signs and uterine fundus. Those needing therapeutic intervention should have been randomized to therapeutic oxytocic alone or uterine massage and oxytocic. Further, monitor the bleeding, apply secondary intervention where and when needed, and then analyze the two groups. I would agree with the authors that, if there is no excessive bleeding, there is no need to deliver the placenta actively.4 The same should have been applied to their population—if there is no need for secondary oxytocics, exclude patients from a postpartum hemorrhage trial before testing a hypothesis. This study was conducted in a correct manner, and the ethical requirements were fulfilled. It is great to see leadership in having a national clinical trial registry. The randomization, exclusion and inclusion criteria, even the measure of the primary and secondary outcomes, were correct. The statistics appear reasonable. The population selected for randomized was, however, wrong. Although this study was level-one evidence, it highlights the pitfalls of evidence-based medicine. We have seen it with the Women’s Health Initiative trial.5,6 After reading and analyzing this publication, I would think that the conclusions of this study cannot be accepted as factual or evidence-based. Focused studies are needed before a simple, cheap, and often effective, even life-saving, procedure in any resource setting is discarded. I did experience it, and I am convinced that, when dealing with an atonic uterus when oxytocics are not working, uterine massage, just like the tension suture at the time of cesarean delivery, could give us the time needed to perform other, more aggressive interventions. Financial Disclosure: The author did not report any potential conflicts of interest.
Emeric P. Fröhlich,
FCOG (SA), FRCOG (London)
Sunninghill Hospital, Johannesburg, South Africa
REFERENCES 1. Chen M, Chang Q, Duan T, He J, Zhang L, Liu X. Uterine massage to reduce blood loss after vaginal delivery: a randomized controlled trial. Obstet Gynecol 2013;122:290–5. 2. Etbourne DR, Prendiville WJ, Carroli G, Wood J, McDonald S. Prophylactic oxytocin for the third stage of labour. The Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD001808. DOI: 10.1002/14651858.CD001808. 3. WHO recommendations for the prevention of postpartum hemorrhage. Available at: http://www.afro.who.int/index.php? option5com_docman&task5doc_download &gid53210. Retrieved October 28, 2013. 4. Gülmezoglu AM, Lumbiganon P, Landoulsi S, Widmer M, AbdelAleem H, Festin M, et al. Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial. Lancet 2012;379:1721–7. 5. Pines A. WHI and aftermath: looking beyond the figures. Maturitas 2005;51: 48–50. 6. Ostrzenski A, Ostrzenska KM. WHI clinical trial revisited: imprecise scientific methodology disqualifies the study outcomes. Obstet Gynecol 2005;193:1599–604.
In Reply: We thank Dr. Fröhlich for his interest in our recent publication pertaining to the effectiveness of routine uterine massage to reduce blood loss after vaginal delivery.1 The raised question is whether those women needing therapeutic oxytocics in our study should have been randomized to therapeutic oxytocic alone or to uterine massage plus therapeutic oxytocic. In our study, we indeed tried to assess the effectiveness of routine uterine massage as a preventative strategy for postpartum hemorrhage and found that this did not provide additional benefit when oxytocin was administered prophylactically. As with many other large trials investigating postpartum hemorrhage prevention,2,3 the use of therapeutic oxytocic was regarded as a secondary outcome rather than an inclusion criterion
OBSTETRICS & GYNECOLOGY
