To estimate whether routine use of intravenous oxytocin decreases the frequency of interventions to control excess blood loss during dilation and evacuation (D&E).
In this multisite, randomized, double-blind, placebo-controlled trial, women undergoing D&E at 18–24 weeks of gestation received 30 units of oxytocin in 500 mL of intravenous fluid or 500 mL of intravenous fluid alone initiated on speculum placement. The primary outcome was the frequency of interventions to control excess bleeding. A sample size of 75 patients per group was needed to detect a 15% decrease in intervention from 20% to 5% with 80% power and two-sided alpha 0.05. Secondary outcomes included measured blood loss, complications, procedure duration, postoperative pain, and patient satisfaction.
From November 2014 to February 2018, we screened 337 women and randomized 160 to receive prophylactic oxytocin (n=82) or placebo (n=78). Demographic characteristics were similar between groups. The frequency of interventions for bleeding, our primary outcome, was 7.3% in the oxytocin group vs 16.7% in the placebo group, difference of 9.4% (95% CI −21.0% to 1.9%). Interventions primarily included uterine massage and uterotonic administration. Among our secondary outcomes, median measured blood loss was lower in the oxytocin group at 152 (interquartile range 98–235) mL vs 317 (interquartile range 168–464) mL (95% CI 71.6–181.5). Frequency of hemorrhage, defined as blood loss of 500 mL or more and 1,000 mL or more, was lower in the oxytocin group at 3.7% vs 21.8%, difference of 18% (95% CI −29 to −6.9%) and 1.2% vs 10.3%, difference of 9.0% (95% CI −17 to −0.7%), respectively. Procedures were shorter in the oxytocin group at a median of 11.0 (interquartile range 8.0–14.0) vs 13.5 (interquartile range 10.0–19.0) minutes in the placebo group (95% CI 1.0–4.0). We found no differences in the frequency of nonhemorrhage complications, pain scores, or satisfaction scores between groups.
Prophylactic use of oxytocin during D&E at 18–24 weeks of gestation did not decrease the frequency of interventions to control bleeding. However, oxytocin did decrease blood loss and frequency of hemorrhage.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT02083809.
Prophylactic oxytocin use during surgical abortion at 18–24 weeks of gestation did not affect rate of interventions for bleeding but decreased blood loss and rate of hemorrhage.
Departments of Obstetrics, Gynecology & Women's Health and Biostatistics & Data Management, University of Hawaii, John A. Burns School of Medicine, Honolulu, Hawaii; and the Department of Obstetrics & Gynecology, University of Washington School of Medicine, Seattle, Washington.
Corresponding author: Katherine Whitehouse, DO, MS, Department of Obstetrics, Gynecology & Women's Health, John A. Burns School of Medicine, University of Hawaii, 1319 Punahou St, Suite 824, Honolulu, HI 96826; email: email@example.com.
Supported by Society of Family Planning grant #SFPRF14-06.
Financial Disclosure Dr. Tschann has received funding for research (through her institution in the form of salary support) from the following corporations in the preceding 3 years: 1) Estetra Pharmaceuticals, 2) Contramed, 3) Merck Sharp & Dohme. Dr. Soon receives research support from Contramed Pharmaceuticals, Merck Sharpe & Dohme, Mithra Pharmaceuticals, Gynuity Health Projects, and the National Institutes of Health. Dr. Kaneshiro receives research support from Contramed Pharmaceuticals (Sebela Pharmaceuticals), Merck Sharpe & Dohme, Mithra Pharmaceuticals, Gynuity Health Projects, and the National Institutes of Health. She is a consultant for UpToDate. The remaining authors did not report any potential conflicts of interest.
Presented at the North American Forum on Family Planning, October 20–22, 2018, New Orleans, Louisiana.
The authors thank EmmaKate Friedlander, Shandhini Raidoo, Leilani Manglicmot, Tiana Fontanilla, Sally Friend, and Alison Goldsmith for their contributions to recruitment and data management.
Each author has confirmed compliance with the journal's requirements for authorship.
Peer reviews and author correspondence are available at http://links.lww.com/AOG/B267.