Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Jun 25;16(6):e0253765.
doi: 10.1371/journal.pone.0253765. eCollection 2021.

Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study)

Pim B B Schol  1   2 , Natascha M de Lange  1   2 , Mallory D Woiski  3 , Josje Langenveld  2 , Luc J M Smits  4 , Martine M Wassen  2 , Yvonne M Henskens  5 , Hubertina C J Scheepers  1   6
Affiliations
Randomized Controlled Trial

Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study)

Pim B B Schol et al. PLoS One. .

Abstract

Background: Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy.

Objective: We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH.

Study design: In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle.

Results: From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups.

Conclusions: Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation.

Trial registration: NTR3789.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow diagram.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesthesia and analgesia. 2010;110(5):1368–73. doi: 10.1213/ANE.0b013e3181d74898 - DOI - PubMed
    1. Ford JB, Patterson JA, Seeho SK, Roberts CL. Trends and outcomes of postpartum haemorrhage, 2003–2011. BMC pregnancy and childbirth. 2015;15:334. doi: 10.1186/s12884-015-0788-5 - DOI - PMC - PubMed
    1. Flood M, McDonald SJ, Pollock W, Cullinane F, Davey MA. Incidence, trends and severity of primary postpartum haemorrhage in Australia: A population-based study using Victorian Perinatal Data Collection data for 764 244 births. The Australian & New Zealand journal of obstetrics & gynaecology. 2019;59(2):228–34. doi: 10.1111/ajo.12826 - DOI - PubMed
    1. Knight M, Callaghan WM, Berg C, Alexander S, Bouvier-Colle MH, Ford JB, et al.. Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group. BMC pregnancy and childbirth. 2009;9:55. doi: 10.1186/1471-2393-9-55 - DOI - PMC - PubMed
    1. van Stralen G, von Schmidt Auf Altenstadt JF, Bloemenkamp KW, van Roosmalen J, Hukkelhoven CW. Increasing incidence of postpartum hemorrhage: the Dutch piece of the puzzle. Acta obstetricia et gynecologica Scandinavica. 2016;95(10):1104–10. doi: 10.1111/aogs.12950 - DOI - PubMed

Publication types

Associated data