Efficacy of methylergometrine during the early puerperium: a randomized double-blind placebo-controlled clinical trial

Abstract

Objective: To determine if oral methylergometrine administration during the first 10 d following spontaneous vaginal delivery has any beneficial effect on the increase of hemoglobin levels.

Methods: This was a parallel group double-blind placebo-controlled clinical trial conducted at single center university hospital in Italy. Participants were puerperal women, who delivered singleton gestation with spontaneous vaginal delivery at term. Participants were randomized into a 1:1 ratio to receive either 0.125 mg methylergometrine per os twice a day or placebo for 10 d. Hemoglobin levels were recorded on the day of delivery and after 10 d. The primary outcome was the variation in hemoglobin levels between the first and the 10th day of treatment.

Results: From December 2012 to October 2015, 220 agreed to take part in the study, underwent randomization, and were enrolled and followed-up. Of the randomized women, 110 (50%) were randomized to the methylergometrine group and 110 (50%) to the placebo group. No women were excluded after randomization or lost to follow-up (100%). We found no significant difference in the median variation of hemoglobin levels between the intervention and the placebo group

Conclusions: The use of 10 d oral methylergometrine in puerperal women was not associated with any benefit in the variation of hemoglobin levels from delivery to 10 d after delivery.

Key Message

• Methylergometrine in puerperal women was not associated with any benefit.

Keywords:

• Bleeding
• breastfeeding
• hemoglobin
• maternal mortality
• postpartum hemorrhage

Disclosure statement

No potential conflict of interest was reported by the authors.

Costantino Di Carlo, the lead author, affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. He had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Additional information

Funding

This work was funded by AIFA (Agenzia Italiana del Farmaco) – [Project no. FARM84KPTK].