TY - JOUR
T1 - Onset of labor and use of analgesia in women using thromboprophylaxis with 2 doses of low-molecular-weight heparin
T2 - insights from the Highlow study
AU - Bistervels, Ingrid M.
AU - Wiegers, Hanke M. G.
AU - ?inle, Fionnuala N.
AU - Bleker, Suzanne M.
AU - Chauleur, C. line
AU - Donnelly, Jennifer
AU - Jacobsen, Anne F.
AU - Rodger, Marc A.
AU - DeSancho, Maria T.
AU - Verhamme, Peter
AU - Hansen, Anette T.
AU - Shmakov, Roman G.
AU - Ganzevoort, Wessel
AU - Buchm?ller, Andrea
AU - Highlow Investigators
AU - Middeldorp, Saskia
N1 - Funding Information:
The Highlow study was partially supported by GSK (2012), which was taken over by Aspen (2016). GSK or Aspen had no role in the design, data collection, analysis, or interpretation of the study results. No funding for this specific analysis was obtained, and authors declare no competing financial interests.
Funding Information:
We thank all women who participated in the Highlow study and all investigators and research staff of the participating study centers. We thank the French Ministry of Health for the financial support in France (2014, PHRC national, number 1408211) and the Irish Health Research Board (HRB) for the financial support in Ireland (Definitive Interventions and Feasibility Awards [DIFA] 2017, number DIFA-2017-040). The Highlow study was endorsed and infrastructurally supported by the Dutch Thrombosis Network, Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology (NVOG Consortium 2.0), by 2 French gynecologic networks (GO-CIC and GROG), by the French network on thrombosis (INNOVTE), by the Irish network for VTE research (INViTE), by the Irish HRB Mother and Baby Clinical Trials Network ( http://www.hrb-mbctni.ie/ ), and by the international network of venous thrombosis networks INVENT ( www.INVENT-VTE.com ). We would like to thank these networks for the collaboration and their support.
Publisher Copyright:
© 2022 International Society on Thrombosis and Haemostasis
PY - 2023/1/1
Y1 - 2023/1/1
N2 - BACKGROUND: Peripartum management of women using low-molecular-weight heparin (LMWH) varies widely. Minimum time intervals are required between LMWH injection and neuraxial procedure, and they differ by dose. OBJECTIVES: The objective of this study was to describe the onset of labor and use of analgesia in women using LMWH and to compare practices between intermediate-dose and low-dose LMWH. METHODS: In the Highlow study (NCT01828697), 1110 women were randomized to intermediate-dose or low-dose LMWH and were instructed to discontinue LMWH when labor commenced unplanned or 24 hours prior to planned delivery. The required time interval since last injection to receive a neuraxial procedure was ?24 hours for intermediate-dose LMWH or ?12 hours for low-dose LMWH. RESULTS: In total, 1018 women had an ongoing pregnancy for ?24 weeks. Onset of labor was spontaneous in 198 of 509 (39%) women on intermediate-dose LMWH and in 246 of 509 (49%) on low-dose LMWH. With unplanned onset, a neuraxial procedure was performed in 37% on intermediate-dose and in 48% on low-dose LMWH (risk difference?-11%, 95% CI?-20% to?-2%). Based on time interval, 61% on intermediate-dose and 82% on low-dose LMWH were eligible for a neuraxial procedure. With planned onset, 68% on intermediate-dose and 66% on low-dose LMWH received a neuraxial procedure, whereas 81% and 93%, respectively, were eligible for a neuraxial procedure (risk difference?-13%, 95% CI?-18% to?-8%). CONCLUSION: With spontaneous onset of labor, neuraxial procedures were performed less often in women using intermediate-dose LMWH. Irrespective of onset, fewer women on intermediate-dose LMWH than those on low-dose LMWH were eligible for neuraxial procedures based on required time intervals since the last LMWH injection.
AB - BACKGROUND: Peripartum management of women using low-molecular-weight heparin (LMWH) varies widely. Minimum time intervals are required between LMWH injection and neuraxial procedure, and they differ by dose. OBJECTIVES: The objective of this study was to describe the onset of labor and use of analgesia in women using LMWH and to compare practices between intermediate-dose and low-dose LMWH. METHODS: In the Highlow study (NCT01828697), 1110 women were randomized to intermediate-dose or low-dose LMWH and were instructed to discontinue LMWH when labor commenced unplanned or 24 hours prior to planned delivery. The required time interval since last injection to receive a neuraxial procedure was ?24 hours for intermediate-dose LMWH or ?12 hours for low-dose LMWH. RESULTS: In total, 1018 women had an ongoing pregnancy for ?24 weeks. Onset of labor was spontaneous in 198 of 509 (39%) women on intermediate-dose LMWH and in 246 of 509 (49%) on low-dose LMWH. With unplanned onset, a neuraxial procedure was performed in 37% on intermediate-dose and in 48% on low-dose LMWH (risk difference?-11%, 95% CI?-20% to?-2%). Based on time interval, 61% on intermediate-dose and 82% on low-dose LMWH were eligible for a neuraxial procedure. With planned onset, 68% on intermediate-dose and 66% on low-dose LMWH received a neuraxial procedure, whereas 81% and 93%, respectively, were eligible for a neuraxial procedure (risk difference?-13%, 95% CI?-18% to?-8%). CONCLUSION: With spontaneous onset of labor, neuraxial procedures were performed less often in women using intermediate-dose LMWH. Irrespective of onset, fewer women on intermediate-dose LMWH than those on low-dose LMWH were eligible for neuraxial procedures based on required time intervals since the last LMWH injection.
KW - anesthesia and analgesia
KW - heparin
KW - labor
KW - low-molecular-weight
KW - obstetric
KW - pregnancy
KW - venous thromboembolism
UR - https://www.scopus.com/pages/publications/85147048363
U2 - 10.1016/j.jtha.2022.11.004
DO - 10.1016/j.jtha.2022.11.004
M3 - Article
C2 - 36695396
SN - 1538-7933
VL - 21
SP - 57
EP - 67
JO - Journal of thrombosis and haemostasis : JTH
JF - Journal of thrombosis and haemostasis : JTH
IS - 1
ER -