TY - JOUR
T1 - Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP)
T2 - Study protocol for a randomized controlled trial
AU - Browne, Joyce L.
AU - Damale, Nelson K.R.
AU - Raams, Tessa M.
AU - Van der Linden, Eva L.
AU - Maya, Ernest T.
AU - Doe, Roseline
AU - Rijken, Marcus J.
AU - Adanu, Richard
AU - Grobbee, Diederick E.
AU - Franx, Arie
AU - Klipstein-Grobusch, Kerstin
N1 - Publisher Copyright: © 2015 Browne et al.
PY - 2015/12/18
Y1 - 2015/12/18
N2 - 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 selfassessment. Methods and Design: 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. Discussion: 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. Trial registration: Clinicaltrials.gov: NCT02223806, registration August 2014. PACTR: PACTR201402000736158, registration July 2014. University of Ghana, Medical School Ethical and Protocol Review Committee: MS-Et/M.8– P4.1/2014-2015
AB - 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 selfassessment. Methods and Design: 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. Discussion: 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. Trial registration: Clinicaltrials.gov: NCT02223806, registration August 2014. PACTR: PACTR201402000736158, registration July 2014. University of Ghana, Medical School Ethical and Protocol Review Committee: MS-Et/M.8– P4.1/2014-2015
KW - Active management of third stage of labor
KW - Low and middle-income countries
KW - Postpartum hemorrhage
KW - Task shifting
KW - Uterine tonus assessment
UR - http://www.scopus.com/inward/record.url?scp=84949986797&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-015-1111-5
DO - https://doi.org/10.1186/s13063-015-1111-5
M3 - Article
C2 - 26683621
SN - 1745-6215
VL - 16
JO - Trials
JF - Trials
IS - 1
M1 - 580
ER -