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DOI: 10.1055/s-0043-122499
Letrozole vs. Placebo Pretreatment in the Medical Management of First Trimester Missed Miscarriage: a Randomized Controlled Trial
Vorbehandlung mit Letrozol vs. Placebo in der medizinischen Behandlung von Fehlgeburten im 1. Trimenon: eine randomisierte, kontrollierte Studie
Abstract
Introduction Misoprostol is used for the medical management of miscarriage as it is more effective in the early stages of pregnancy. Letrozole has an anti-estrogen effect and is used for the pretreatment of miscarriage with misoprostol.
Aim The aim of this study was compare the efficacy and safety of letrozole with placebo pretreatment in the medical management of first trimester missed miscarriage.
Design This was a prospective randomized case-control study.
Patients and Methods Four hundred and thirty-eight women were randomly divided into two groups of 219; the placebo group received placebo tablets twice daily for 3 days, followed by 800 micrograms of misoprostol vaginally on the fourth day of enrolment, while the letrozole group received letrozole 10 mg twice daily for three days followed by 800 micrograms misoprostol administered vaginally. Symptoms and side effects were recorded, and the women advised to return to hospital if they experienced severe pain or bleeding or intolerable side effects and to report to hospital for a check-up one week after misoprostol administration. Ultrasound was done seven days after misoprostol administration to monitor outcomes. Surgical evacuation was carried out if medical management failed.
Results There were significant differences between the two groups, with better outcomes found for the letrozole group in terms of rates of complete miscarriage, onset of vaginal bleeding, and interval between induction and onset of expulsion (p < 0.001). A higher rate of nausea and vomiting was reported for the letrozole group (p = 0.002). Differences between groups with regard to pre- and post-termination hemoglobin levels, fever, severe pain and severe bleeding needing evacuation were not statistically significant.
Conclusion Adding letrozole to misoprostol improves the success rate and decreases the interval between induction and expulsion in cases of first trimester miscarriage; however, nausea and vomiting is higher with letrozole.
Zusammenfassung
Einleitung Misoprostol wird für die medizinische Behandlung von Fehlgeburten eingesetzt, da es sich in der Frühschwangerschaft als effektiver erwiesen hat. Letrozol hat eine antiöstrogene Wirkung und wird für die Vorbehandlung von Fehlgeburten mit Misoprostol eingesetzt.
Ziel Ziel dieser Studie war es, die Effektivität und Sicherheit einer Vorbehandlung mit Letrozol mit Placebo zu vergleichen, bei der medizinischen Behandlung einer Fehlgeburt im 1. Trimenon.
Studiendesign Es handelte sich um eine prospektive randomisierte Fallkontrollstudie.
Patientinnen und Methoden 438 Frauen wurden in 2 Gruppen mit je 219 Teilnehmerinnen randomisiert; die Placebogruppe erhielten Placebotabletten 2-mal täglich über 3 Tage, gefolgt von 800 Mikrogramm Misoprostol, die am 4. Tag nach Aufnahme in der Studie vaginal verabreicht wurden; die Letrozol-Gruppe erhielt 10 mg Letrozol 2-mal täglich über 3 Tage, gefolgt von 800 Mikrogramm Misoprostol vaginal verabreicht. Symptome und Nebenwirkungen wurden aufgezeichnet. Den Frauen wurde geraten, sich im Krankenhaus zu melden, falls sie starke Schmerzen oder Blutungen bzw. unerträgliche Nebenwirkungen verspüren sollten, und sich 1 Woche nach der Verabreichung von Misoprostol beim Krankenhaus für eine Nachuntersuchung einzustellen. Sieben Tage nach der Verabreichung von Misoprostol wurde eine Ultraschalluntersuchung durchgeführt, um das Ergebnis zu kontrollieren. Falls die medizinische Behandlung der Fehlgeburt fehlschlug, wurde ein chirurgischer Abbruch durchgeführt.
Ergebnisse Es gab signifikante Unterschiede zwischen den beiden Gruppen: die Ergebnisse der Letrozol-Gruppe waren besser hinsichtlich der Rate vollständiger Fehlgeburten, des Beginns der vaginalen Blutung und des Zeitabstands zwischen Induktion und Beginn der Austreibung (p < 0,001). Übelkeit und Erbrechen traten häufiger in der Letrozol-Gruppe auf (p = 0,002). Es gab keinen statistisch signifikanten Unterschied zwischen den beiden Gruppen hinsichtlich der Hämoglobin-Werte vor und nach dem Abbruch bzw. des Auftretens von Fieber, starken Schmerzen oder starken Blutungen, die eine chirurgische Intervention erforderlich machten.
Schlussfolgerung Die Gabe von Letrozol vor einer Behandlung mit Misoprostol erhöht die Erfolgsrate und verringert den Zeitabstand zwischen medizinischer Induktion und Austreibung bei Fehlgeburten im 1. Trimenon; Übelkeit und Erbrechen kommen häufiger nach Letrozol-Gabe vor.
Publication History
Received: 01 July 2017
Accepted after revision: 07 November 2017
Publication Date:
22 January 2018 (online)
© 2018. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Georg Thieme Verlag KG
Stuttgart · New York
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