A randomized controlled trial of methylergonovine prophylaxis after dilation and evacuation abortion.

Abstract

OBJECTIVE:

To evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20-24 weeks.

STUDY DESIGN:

We performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects.

RESULTS:

From March 3, 2015 to March 31, 2017, we randomized 284 participants (n = 140 methylergonovine, n = 144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p = 0.5). Methylergonovine recipients required more intrauterine balloon use (n = 20 [14%]) versus placebo (n = 10 [7%]), p = 0.04. We also observed a non-significant trend towards more uterotonic administration (n = 56 [40%] versus n = 43 [30%], p = 0.07) and hospital admissions for bleeding (n = 4 [3%] versus n = 0, p = 0.06) in the methylergonovine group compared to placebo.

CONCLUSION:

We observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E.

IMPLICATIONS:

When administered prophylactically immediately after dilation and evacuation abortion at 20-24 weeks, methylergonovine increases uterine bleeding. Given the lack of data for effectiveness as a prophylactic agent and our findings indicating harm, we do not recommend its use for post-operative prophylaxis.

• Authors: Jennifer L Kerns, Geffan Pearlson, Biftu Mengesha, Kristin Harter, Rebecca A Jackson, Eleanor A Drey
• Journal: Contraception (Contraception) Vol. 103 Issue 2 Pg. 116-120 (02 2021) ISSN: 1879-0518 [Electronic] United States
• PMID: 33075332 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2020 Elsevier Inc. All rights reserved.

Chemical References

• Methylergonovine

Topics

• Abortion, Induced
• Abortion, Spontaneous
• Dilatation
• Female
• Humans
• Methylergonovine
• Pregnancy
• Uterine Hemorrhage (prevention & control)