Fundal pressure versus controlled cord traction as part of the active management of the third stage of labour (Review)

Transcription

1 Fundal pressure versus controlled cord traction as part of the active management of the third stage of labour (Review) Peña-Martí GE, Comunián-Carrasco G This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 11

2 T A B L E O F C O N T E N T S HEADER ABSTRACT PLAIN LANGUAGE SUMMARY BACKGROUND OBJECTIVES METHODS RESULTS DISCUSSION AUTHORS CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES CHARACTERISTICS OF STUDIES DATA AND ANALYSES APPENDICES WHAT S NEW HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT INDEX TERMS i

3 [Intervention Review] Fundal pressure versus controlled cord traction as part of the active management of the third stage of labour Guiomar E Peña-Martí 1, Gabriella Comunián-Carrasco 1 1 Departamento de Obstetricia y Ginecología, Universidad de Carabobo, Valencia, Venezuela Contact address: Guiomar E Peña-Martí, Departamento de Obstetricia y Ginecología, Universidad de Carabobo, La Esmeralda, calle 160, D10-7, San Diego, Valencia, Estado Carabobo, 2006, Venezuela. gpena@uc.edu.ve. guiomarhelena@cantv.net. Editorial group: Cochrane Pregnancy and Childbirth Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 11, Review content assessed as up-to-date: 16 September Citation: Peña-Martí GE, Comunián-Carrasco G. Fundal pressure versus controlled cord traction as part of the active management of the third stage of labour. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD DOI: / CD pub2. Background A B S T R A C T There are two basic interventions to help to deliver the placenta as part of the active management of the third stage of labour: (1) fundal pressure, and (2) controlled traction on the umbilical cord. Both of these methods may, in addition, have adverse outcomes. Fundal pressure may interrupt the process of placental detachment and cause pain, haemorrhage or uterine inversion, and controlled cord traction, if undertaken before placental separation or without prior administration of a uterotonic drug, may have similar adverse effects. The obstetric clinical practice on this issue is not standardised. Objectives To determine the efficacy of fundal pressure versus controlled cord traction as part of the active management of the third stage of labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group s Trials Register (August 2010). Selection criteria We searched for published and unpublished randomised and quasi-randomised controlled trials. Data collection and analysis Two review authors independently identified potential studies from the literature search and assessed them for methodological quality and appropriateness of inclusion. Main results The search strategies yielded five studies for consideration of inclusion. However, none of these studies fulfilled the requirements for inclusion in this review. 1

4 Authors conclusions We identified no randomised controlled trials comparing the efficacy of fundal pressure versus controlled cord traction as part of the active management of the third stage of labour. Hence controlled cord traction, after awaiting signs of placental separation, should remain the third component of the active management of third stage of labour, and follow the routine administration of a uterotonic drug and cord clamping. P L A I N L A N G U A G E S U M M A R Y Fundal pressure versus controlled cord traction as part of the active management of the third stage of labour Controlled cord traction to deliver the placenta should remain as part of the active management of third stage of labour. The third stage of labour is the period from the birth of the baby until delivery of the placenta. There are two basic interventions to help to deliver the placenta as part of the active management of the third stage of labour: fundal pressure or controlled cord traction. Fundal pressure (Crede manoeuvre) involves placing one hand on the top of the uterus (uterine fundus) and squeezing it between the thumb and other fingers to help placental separation and delivery. Controlled cord traction involves traction on the umbilical cord while maintaining counter-pressure upwards by placing a hand on the lower abdomen. Also, controlled cord traction should only follow signs of placental separation. Both these interventions, if not performed correctly, may have adverse outcomes including pain, haemorrhage and inversion of the uterus. Two other methods of placenta delivery are not advised because they may be dangerous: these are uterine manipulation and cord traction. The review found no randomised controlled trials to assess the use of fundal pressure as part of the active management of the third stage of labour. Therefore, controlled cord traction should continue as the method of placental delivery in the active management of third stage of labour. B A C K G R O U N D The third stage of labour is the period from the birth of the baby until delivery of the placenta. After the birth of the baby and the cessation of umbilical cord pulsation, the placenta separates from the uterine wall through the sponge lining of the decidua spongiosa and is delivered through the birth canal (Burnett 2001; Inch 1985). Separation of the placenta usually begins after the birth of the baby, as a result of uterine retraction or with the first contractions of the empty uterus. The classical signs of placental separation are: alteration of the form and size of the uterus, blood loss, descent and lengthening of the umbilical cord and the elevation of the uterine fundus (McDonald 2003). All signs are not always as apparent as this. The only definite sign of separation is when the placenta is expelled through the birth canal. There are a number of techniques to deliver the placenta once it has separated. According to popular opinion, two are not advised because they may be dangerous: (1) uterine manipulation, and (2) traction of the umbilical cord. Uterine manipulation may interrupt the process of placental detachment, and can cause pain, haemorrhage and uterine inversion. Traction of the umbilical cord, if undertaken before placental separation and without counter pressure, or without prior administration of a uterotonic drug, may also cause pain, haemorrhage or uterine inversion (Käser 1972; Lipitz 1988). The estimated number of maternal deaths in 2000 for the world was 529,000 (WHO 2004). Many of these deaths resulted from complications of the third stage of labour. The pregnancy-related (direct) maternal mortality rate in the United States is approximately seven to 10 women per 100,000 live births. National statistics suggest that approximately 8% of these deaths are caused by postpartum haemorrhage (PPH) (Berg 1996). In the developing world, maternal deaths due to PPH range from 5.9% to 48.5% (Khan 2006). The death of these mothers has serious implications for the newborn and any other surviving children. PPH is defined as an estimated maternal blood loss of 500 ml or more within 24 hours of delivery. Most healthy women can tolerate 500 to 1000 ml blood loss without serious morbidity (Bais 2004). The degree of blood loss associated with placental separation and delivery depends on how effectively the uterine muscles contract around the placental bed during and after separation, and whether there is any interference such as pulling on the cord prior to placental separation. The degree of blood loss will also be associated with the woman s blood clotting profile. The absolute timing for delivery of the placenta, without evidence of significant bleeding, remains unclear, but a period of about 10 minutes has been iden- 2

5 tified with active management of third stage (Gülmezoglu 2004; Prendiville 2000). The most important aim of the management of the third stage of labour is to avoid large amounts of blood loss (Käser 1972; Prendiville 2000). Evidence shows that management of the third stage can directly influence important maternal outcomes such as blood loss, and the need for manual removal of the placenta (Brucker 2001). The third stage of labour can be managed actively or expectantly. For the mother, the third stage of labour is potentially the most hazardous part of childbirth, mainly because of the risk of PPH. As a measure to prevent PPH, active management has been widely adopted. Active management generally involves all three of the following interventions: routine prophylactic administration of a uterotonic agent, early cord clamping and controlled cord traction (Prendiville 1989; Prendiville 2000; Rogers 1998). Controlled cord traction involves traction on the cord while maintaining counter-pressure upwards on the lower segment of the uterus, using a hand placed on the lower abdomen. The Crede manoeuvre for fundal pressure is a method to separate the placenta after delivery. One hand is placed on the uterine fundus and the uterus squeezed between the thumb and other fingers to facilitate placental separation and expel the placenta through the birth canal (Brandt 1933). However, this manoeuvre may produce great pain, so some do not recommend it (Beisher 2000). The length of third stage using this method is usually between five and 15 minutes (Beisher 2000). An alternative to active management of the third stage of labour is expectant management (sometimes called conservative or physiological management). In expectant management, uterotonic drugs are not given prophylactically, the cord is neither clamped nor cut early, nor is controlled cord traction performed and the placenta is expelled by maternal effort in its own time. The length of expectant management is about 15 to 30 minutes (Usandizaga 1997). Faulty management of the third stage of labour may increase the risk of inversion of the uterus (Miras 2002). Whether cord traction is free of danger, as has been claimed in recent years, remains unclear (Meinert 1984). However, the cord traction method in the third stage of labour could be dangerous in spite of other advantages (Sterigev 1979), whereas controlled cord traction is the standard third component of the active management of third stage (Prendiville 2000). Whether fundal pressure might be a more effective third component of the active management of third stage of labour merits investigation. M E T H O D S Criteria for considering studies for this review Types of studies Randomised and quasi-randomised controlled trials. Types of participants Women after vaginal birth where active management of the third stage is to be used (with other components of active management of the third stage being noted). Types of interventions Following routine administration of a uterotonic drug and early cord clamping: 1. Fundal pressure (Crede manoeuvre): a method to separate the placenta after delivery, by placing the hand on the uterine fundus in order to squeeze between the fingers the fundus to make the placenta separate and expel the placenta through the birth canal. 2. Controlled cord traction: involves traction on the cord while maintaining counter-pressure upwards on the lower segment of the uterus, using a hand placed on the lower abdomen. Types of outcome measures Postpartum haemorrhage Severe postpartum haemorrhage (clinically estimated blood loss of at least 1000 ml) Length (or duration) of the third stage of labour Number of units of packed red cell transfused Number of participants transfused Number of doses of uterotonic agents Maternal pain during the third stage of labour Length of stay in hospital Retained placenta Manual removal of placenta Uterine inversion Use of analgesics O B J E C T I V E S To determine the efficacy of fundal pressure versus controlled cord traction as part of the active management of the third stage of labour. Search methods for identification of studies Electronic searches 3

6 We searched the Cochrane Pregnancy and Childbirth Group s Trials Register by contacting the Trials Search Co-ordinator (August 2010). The Cochrane Pregnancy and Childbirth Group s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from: 1. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL); 2. weekly searches of MEDLINE; 3. handsearches of 30 journals and the proceedings of major conferences; 4. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central alerts. Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the Specialized Register section within the editorial information about the Cochrane Pregnancy and Childbirth Group. Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords. For details of the additional searches carried out in the previous version of this review, please see Appendix 1. We did not apply any language restrictions. Data collection and analysis Study selection We screened the results of the search strategy for potentially relevant trials and independently assessed them for inclusion using a predesigned eligibility form based on the inclusion criteria. We resolved disagreements through discussion until a consensus was reached. We were unable to identify any randomised controlled trials eligible for inclusion in this Cochrane review. Therefore, we could not perform the data analyses that we had planned. If trials are identified and included in the review in future, we will adhere to the protocol as described below and, where necessary, request any additional information from the main study authors. Assessment of methodological quality of included studies We will assess the validity of each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2005). (1) Selection bias (randomisation and allocation concealment) We will assign a quality score for each trial, using the following criteria: (A) adequate concealment of allocation, such as telephone randomisation, consecutively-numbered, sealed opaque envelopes; (B) unclear whether adequate concealment of allocation; (C) inadequate concealment of allocation, such as open list of random-number tables, sealed envelopes. (2) Performance bias (blinding of participants, researchers and outcome assessment) We will assess blinding using the following criteria: (A) blinding of participants (yes/no/unclear); (B) blinding of caregiver (yes/no/unclear); (C) blinding of outcome assessment (yes/no/unclear). However, it will not be possible to blind participants and caregivers when using these interventions. (3) Attrition bias (loss to follow up) We will assess completeness to follow up using the following criteria: (A) less than 5% of participants excluded; (B) 5% to 10% of participants excluded; (C) more than 10% and less than 20% of participants excluded; (D) more than 20% of participants excluded. Data extraction and management Guiomar Peña-Martí (GP) will design a form to extract data and Gabriella Comunián-Carrasco (GC) will validate it. GP and GC will extract the data independently using the agreed form. We will resolve discrepancies through discussion. We will use the Review Manager software (RevMan 2003) to double enter the data. When information regarding any of the above is unclear, we will attempt to contact authors of the original reports to provide further details. Measures of treatment effect We will carry out statistical analysis using the Review Manager software (RevMan 2003). We will use fixed-effect meta-analysis for combining data if trials are sufficiently similar. For dichotomous data, we will present results as summary relative risks with 95% confidence intervals. For continuous data, we will use the weighted mean difference if outcomes are measured in the same way between trials. We will use the standardised mean difference to combine trials that measure the same outcome, but use different methods. If there is evidence of skewness we will report this. 4

7 We will analyse data on an intention-to-treat basis. Therefore, all participants with available data will be included in the analysis in the group to which they are allocated, regardless of whether or not they received the allocated intervention. If in the original reports participants are not analysed in the group to which they were randomised, and there is sufficient information in the trial report, we will attempt to restore them to the correct group. Assessment of heterogeneity We will apply tests of heterogeneity between trials if appropriate using the I² statistic. If we identify high levels of heterogeneity among the trials (exceeding 50%), we will explore it by performing sensitivity analysis. A random-effects meta-analysis will be used as an overall summary if this is considered appropriate. Sensitivity analyses We will carry out sensitivity analysis to explore the effect of trial quality. This will involve analysis based on an A, B, C or D rating of selection bias, performance bias and attrition bias, as well as including and excluding quasi-randomised trials. The results of high-quality studies will be compared with those of poorer quality studies, where studies rated A for all quality criteria will be compared with those rated B, C or D. R E S U L T S Description of studies See: Characteristics of excluded studies. The search strategies yielded five studies for consideration of inclusion. However, none of these studies met the basic inclusion criteria of comparing controlled cord traction versus fundal pressure. For more information, see the table Characteristics of excluded studies. D I S C U S S I O N There are currently no randomised, or quasi-randomised, controlled trials comparing fundal pressure with controlled cord traction as part of the active management of the third stage of labour. One trial, which probably came closest to the research question, assessed (following intramuscular oxytocic administration) the use of controlled cord traction compared with maternal effort and fundal pressure only if maternal effort was unsuccessful (Bonham 1963). This trial showed controlled cord traction associated with less blood loss. In order to consider the benefits and risks of fundal pressure compared with controlled cord traction as part of the active management of third stage, a randomised controlled trial comparing both interventions would need to be conducted. However, it may not be a research priority given the suggested disadvantages of Crede fundal pressure (Lipitz 1988; Miras 2002). A U T H O R S C O N C L U S I O N S Implications for practice The evidence shows there are no randomised controlled trials to support the use of fundal pressure rather than controlled cord traction as part of the active management of the third stage of labour. Therefore, controlled cord traction should continue as the method of placental delivery in the active management of third stage of labour. Implications for research A randomised controlled trial to compare fundal pressure with controlled cord traction as part of the active management of third stage of labour is probably not a research priority. Risk of bias in included studies We did not identify any studies that were eligible for inclusion in this Cochrane review. Effects of interventions The searches did not identify any randomised controlled trials eligible for inclusion in this Cochrane review. A C K N O W L E D G E M E N T S We would like to thank: the Iberoamerican Cochrane Centre, Spain for their help and support; peer-reviewers for improving the quality of this Cochrane review; Mrs Sonja Henderson and Ms Lynn Hampson for their help; and Mrs Gill Gyte, who helped to revise the final draft in response to editorial comments. 5

8 R E F E R E N C E S References to studies excluded from this review Bonham 1963 {published data only} Bonham DG. Intramuscular oxytocics and cord traction in third stage of labour. BMJ 1963;2: Giacalone 2000 {published data only} Giacalone PL, Vignal J, Daures JP, Boulot P, Hedon B, Laffargue F. A randomised evaluation of two techniques of management of the third stage of labour in women at low risk of postpartum haemorrhage. BJOG: an international journal of obstetrics and gynaecology 2000;107: Kemp 1971 {published data only} Kemp J. A review of cord traction in the third stage of labour from 1963 to Medical Journal of Australia 1971;1(17): Khan 1997 {published data only} Khan GQ, John IS, Wani S, Doherty T, Sibai BM. Controlled cord traction versus minimal intervention techniques in delivery of the placenta: a randomized controlled trial. American Journal of Obstetrics and Gynecology 1997;177: Sharma 2005 {published data only} Sharma JB, Pundir P, Malhotra M, Arora R. Evaluation of placental drainage as a method of placental delivery in vaginal deliveries. Archives of Gynecology & Obstetrics 2005; 271(4): Thomas 1990 {published data only} Thomas IL, Jeffers TM, Brazier JM, Burt CL, Barr KE. Does cord drainage of placental blood facilitate delivery of the placenta?. Australian and New Zealand Journal of Obstetrics and Gynaecology 1990;30: Additional references Bais 2004 Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Postpartum haemorrhage in nulliparous women: incidence and risk factors in low and high risk women. A Dutch populationbased cohort study on standard (> or = 500 ml) and severe (> or = 1000 ml) postpartum haemorrhage. European Journal of Obstetrics & Gynecology and Reproductive Biology 2004;115(2): Beisher 2000 Beisher N, Mackay E, Colditz P. Obstetricia y Neonatología. Tercera edición. México: McGraw-Hill Interamericana, Berg 1996 Berg CJ, Atrash HK, Koonin LM, Tucker M. Pregnancyrelated mortality in the United States Obstetrics & Gynecology 1996;88(2): Brandt 1933 Brandt ML. The mechanism and management of the third stage of labor. American Journal of Obstetrics and Gynecology 1933;23: Brucker 2001 Brucker MC. Management of the third stage of labor: an evidence-based approach. Journal of Midwifery and Women s Health 2001;46(6): Burnett 2001 Burnett A. Clinical obstetrics and gynecology: a problem-based approach. Oxford: Blackwell Science, Gülmezoglu 2004 Gülmezoglu AM, Forna F, Villar J, Hofmeyr GJ. Prostaglandins for preventing postpartum haemorrhage. Cochrane Database of Systematic Reviews 2007, Issue 3. [Art. No.: CD DOI: / CD pub3] Higgins 2005 Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions [updated May 2005]. In: The Cochrane Library, Issue 3, Chichester, UK: John Wiley & Sons, Ltd.. Inch 1985 Inch S. Management of the third stage of labour - another cascade of intervention?. Midwifery 1985;1: Khan 2006 Khan KS, Wojdyla D, Say L, Gülmezoglu AM, Van Look PFA. WHO analysis of causes of maternal death: a systematic review. Lancet 2006;367: Käser 1972 Käser O, Friedberg V, Ober KG, Thomsen K, Sander J. Ginecología y obstetricia. Salvat Editores, Lipitz 1988 Lipitz S, Frenkel Y. Puerperal inversion of the uterus. European Journal of Obstetrics & Gynecology and Reproductive Biology 1988;27: McDonald 2003 McDonald S. Physiology and management of the third stage of labour. In: Fraser DM, Cooper MA editor(s). Myles textbook for midwives. 14. Churchill Livingstone, 2003: Meinert 1984 Meinert J. Puerperal inversion of the uterus. Geburtshilfe und Frauenheilkunde 1984;44: Miras 2002 Miras T, Collet F, Seffert P. Acute puerperal uterine inversion: two cases [Inversion utérine puerpérale aiguë: à propos de deux cas]. Journal de Gynécologie, Obstétrique et Biologie de la Reproduction 2002;31(7): Prendiville 1989 Prendiville WJ, Elbourne D. Care during the third stage of labour. In: Chalmers I, Enkin M, Keirse MJNC editor(s). Effective care in pregnancy and childbirth. Oxford University Press, 1989: Prendiville 2000 Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management in the third stage of labour. 6

9 Cochrane Database of Systematic Reviews 2000, Issue 3. [Art. No.: CD DOI: / CD000007] RevMan 2003 The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 4.2 for Windows. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, Rogers 1998 Rogers J, Wood J, McCandlish R, Ayers S, Truesdale A, Elbourne D. Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial. Lancet 1998;351(9104): Sterigev 1979 Sterigev K, Dadasovi M, Lederer B. Inversion of the uterus during cord traction. Jugoslavenska Ginekologija i Opstetricija 1979;19: Usandizaga 1997 Usandizaga JA, de la Fuente P. Tratado de Obstetricia y Ginecologia. McGraw Hill Interamericana, WHO 2004 World Health Organization. World Health Organization Estimates Developed by WHO, UNICEF and UNFPA. Maternal mortality in 2000: estimates developed by WHO, UNICEF and UNFPA. mortality_2000.pdf (accessed 2004). Indicates the major publication for the study 7

10 C H A R A C T E R I S T I C S O F S T U D I E S Characteristics of excluded studies [ordered by study ID] Study Bonham 1963 Giacalone 2000 Kemp 1971 Khan 1997 Sharma 2005 Thomas 1990 Reason for exclusion Quasi RCT compared cord traction with maternal effort and then fundal pressure if maternal effort was unsuccessful RCT compared placental cord drainage plus cord traction with expectant delivery. It is unclear how many women required fundal presssure Quasi RCT compared cord traction as part of the active management of third stage with syntometrine plus abdominal manipulation. Throughout the paper, the term abdominal manipulation was used, except in the printed instructions for staff where it was called gentle fundal pressure. This study was excluded because it was about cord traction rather than controlled cord traction and the control group also included early dividing of the umbilical cord RCT compared controlled cord traction with a minimal intervention group where the placenta was delivered by maternal effort RCT compared placental cord drainage with controlled cord traction RCT compared placental cord drainage plus controlled cord traction with controlled cord traction RCT: Randomised controlled trial 8

11 D A T A A N D A N A L Y S E S This review has no analyses. A P P E N D I C E S Appendix 1. Search strategy (CENTRAL) (The Cochrane Library 2006, Issue 2); MEDLINE (1966 to April 2006); EMBASE (1988 to April 2006) and LILACS (1982 to April 2006) (third stage OR 3rd stage OR cord traction OR fund* pressure OR uterine inversion) AND (postpartum haemorrhage OR post partum haemorrhage OR post-partum haemorrhage OR postpartum hemorrhage OR post partum hemorrhage OR post-partum hemorrhage OR pph OR blood loss OR blood-loss OR blood loss). W H A T S N E W Last assessed as up-to-date: 16 September Date Event Description 6 August 2010 New search has been performed Search updated. No new trials identified. H I S T O R Y Protocol first published: Issue 3, 2005 Review first published: Issue 4, 2007 Date Event Description 3 September 2008 Amended Converted to new review format. 9

12 C O N T R I B U T I O N S O F A U T H O R S Dr Peña developed and wrote the protocol and the first draft of the review. Dr Comunián provided general advice on the protocol and the review. D E C L A R A T I O N S O F None known. I N T E R E S T S O U R C E S O F S U P P O R T Internal sources Universidad de Carabobo, Venezuela. External sources Iberoamerican Cochrane Centre, Spain. I N D E X T E R M S Medical Subject Headings (MeSH) Labor Stage, Third; Placenta; Umbilical Cord; Delivery, Obstetric [ methods]; Pressure; Traction [methods]; Uterus MeSH check words Female; Humans; Pregnancy 10