Intramuscular 17α-hydroxyprogesterone caproate to decrease preterm delivery in women with placenta praevia: a randomised controlled trial

J Obstet Gynaecol. 2020 Jul;40(5):633-638. doi: 10.1080/01443615.2019.1645099. Epub 2019 Oct 31.

Abstract

We tested the hypothesis that 17α-hydroxyprogesterone caproate (17α-OHP-C) may decrease preterm delivery (PTD) in women with placenta praevia. This was a randomised controlled trial included 114 women with placenta praevia (between 24 and 28 weeks). They were randomly assigned to group I (17α-OHP-C) who received weekly injection of 17α-OHP-C (250 mg/IM) till completing 37 weeks' gestation or group II (Non 17α-OHP-C). The percentage of placenta praevia patients went into PTD in the 17α-OHP-C group was significantly less in comparison to the PTD in the Non 17α-OHP-C group (∼37% vs. 63.5%, p = .004). Furthermore, the mean gestational age was significantly longer (36.7 ± 0.7 vs. 34.9 ± 1.2 weeks, p < .000), the mean number of bleeding attacks was significantly less and the mean birth weight was significantly higher (2841 ± 159 vs. 2561 ± 168 g, p < .000). In conclusion, maintenance tocolysis with intramuscular 17α-OHP-C in placenta praevia women appears beneficial in decreasing the number of bleeding attacks, the percentage of PTD and the neonatal ICU admission.IMPACT STATEMENTWhat is already known on this subject? Over the last two decades, a large number of studies indicated that placenta praevia is a major risk factor for preterm labour and prematurity with its neonatal complications. Increasing caesarean section rates had proportionally increased the incidence of placenta praevia.What do the results of this study add? Up to now, the effective and safe tocolytic agent among these patients is not established. The results of this study (prospective, randomised and controlled with calculated sample size) added a considerable support for hydroxyprogesterone caproate as an effective, safe and cheap tocolytic agent with excellent patient compliance.What are the implications of these findings for clinical practice and/or further research? Our findings may prompt researchers to conduct a large multicentre study to evaluate the prophylactic use of hydroxyprogesterone caproate to decrease preterm labour due to placenta praevia.

Keywords: 17α-hydroxyprogesterone caproate; placenta praevia; preterm delivery.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 17 alpha-Hydroxyprogesterone Caproate / administration & dosage*
  • 17 alpha-Hydroxyprogesterone Caproate / pharmacology
  • Adult
  • Cesarean Section / statistics & numerical data
  • Female
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Injections, Intramuscular
  • Placenta Previa / drug therapy*
  • Pregnancy
  • Premature Birth / prevention & control*
  • Tocolytic Agents / administration & dosage*
  • Tocolytic Agents / pharmacology

Substances

  • Tocolytic Agents
  • 17 alpha-Hydroxyprogesterone Caproate