title: Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide and accounts for one third of maternal deaths in low-income and middle-income countries. PPH can be prevented by active management of the third stage of labor (AMTSL), a series of steps recommended by the World Health Organization to be performed by skilled birth attendants (SBAs). Task shifting in the AMTSL step of uterotonic drugs administration to community health workers, traditional birth attendants and self-administration has been investigated as a strategy to increase access to quality obstetric care considering persistent SBA and facility-based delivery shortages. The aim of this study is to assess task shifting in the final step of AMTSL and compare uterine tonus assessment by a SBA to self-assessment.
  
  
  METHODS
  The study is an individual-level two-arm non-inferiority randomized controlled trial (RCT). A total of 800 women will be recruited in Korle Bu Teaching Hospital in Accra, Ghana. Adult women in labor at term with an expected vaginal delivery who received antenatal instructions for self-assessment of uterine tonus will be eligible for inclusion. Women with an increased risk for PPH will be excluded. Women will be randomized to uterine tone assessment by a skilled birth attendant (midwife) or uterine tone self-assessment (with the safety back-up of a midwife present in case of PPH or uterine atony). Postpartum blood loss will be measured through weighing of disposable mats. The main study endpoints are PPH (≥500 ml blood loss), severe PPH (≥1000 ml blood loss), mean blood loss, and routine maternal and neonatal outcomes. Participants and caregivers will not be blinded given the nature of the intervention.
  
  
  CONCLUSIONS
  A reduction of PPH-related maternal mortality requires full implementation of AMTSL. Task shifting of uterine tone assessment may contribute to increased AMTSL implementation in (clinical) settings where SBAs capacity is constrained.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT02223806 , registration August 2014.
  PACTR201402000736158 , registration July 2014. University of Ghana, Medical School Ethical and Protocol Review Committee: MS-Et/M.8-P4.1/2014-2015.
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. J.L.Browne@umcutrecht.nl.
authors.forename: Joyce L
authors.initials: JL
authors.lastname: Browne
authors.affiliation: School of Medicine and Dentistry, College of Health Sciences, University of Ghana, Accra, Ghana. ndamale@yahoo.co.uk.|Department of Obstetrics and Gynecology, Korle Bu Teaching Hospital, Accra, Ghana. ndamale@yahoo.co.uk.
authors.forename: Nelson K R
authors.initials: NK
authors.lastname: Damale
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. tessa.raams@gmail.com.
authors.forename: Tessa M
authors.initials: TM
authors.lastname: Raams
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. e.vanderlinden@hotmail.com.
authors.forename: Eva L
authors.initials: EL
authors.lastname: Van der Linden
authors.affiliation: School of Medicine and Dentistry, College of Health Sciences, University of Ghana, Accra, Ghana. emaya@ug.edu.gh.|School of Public Health, College of Health Sciences, University of Ghana, Accra, Ghana. emaya@ug.edu.gh.
authors.forename: Ernest T
authors.initials: ET
authors.lastname: Maya
authors.affiliation: Department of Obstetrics and Gynecology, Korle Bu Teaching Hospital, Accra, Ghana. roselinedoe16@yahoo.com.|WHO Country Office Ghana, World Health Organization, Accra, Ghana. roselinedoe16@yahoo.com.
authors.forename: Roseline
authors.initials: R
authors.lastname: Doe
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. M.J.Rijken@umcutrecht.nl.|Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands. M.J.Rijken@umcutrecht.nl.
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Rijken
authors.affiliation: School of Public Health, College of Health Sciences, University of Ghana, Accra, Ghana. rmadanu@ug.edu.gh.
authors.forename: Richard
authors.initials: R
authors.lastname: Adanu
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. D.E.Grobbee@umcutrecht.nl.
authors.forename: Diederick E
authors.initials: DE
authors.lastname: Grobbee
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands. A.Franx-2@umcutrecht.nl.
authors.forename: Arie
authors.initials: A
authors.lastname: Franx
authors.affiliation: Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. K.Klipstein-Grobusch@umcutrecht.nl.|Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. K.Klipstein-Grobusch@umcutrecht.nl.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Klipstein-Grobusch
mesh_terms: D002985:Clinical Protocols; D036861:Delivery, Obstetric; D059026:Diagnostic Self Evaluation; D005260:Female; D005869:Ghana; D006801:Humans; D007749:Labor Stage, Third; D008880:Midwifery; D009129:Muscle Tonus; D006473:Postpartum Hemorrhage / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D011247:Pregnancy; D012107:Research Design; D016896:Treatment Outcome; D014590:Uterine Contraction; D014599:Uterus / Q000503:physiopathology*