Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

Study Overview

• Status: Unknown
• Conditions: Missed Abortion
• Intervention / Treatment: Drug: Letrozole then misoprostol; Drug: placebo then misoprostol

Detailed Description

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Gestational age less than 64 days gestation (<9 wks).
• Hemoglobin >10 g/dL.
• BMI between 18.5 kg/m2 and 25 kg/m2.
• Missed abortion.

Exclusion Criteria:

• Molar pregnancy.
• Fibroid uterus.
• Uterine anomalies.
• Coagulopathy.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or letrozole.
• Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; 2 tablets of Letrozole 2.5 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.	Drug: Letrozole then misoprostol; total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
Placebo Comparator: control group; 2 tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum three doses	Drug: placebo then misoprostol; placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete abortion rate	Incidence of complete miscarriage	9 hours
time from induction to abortion	induction to abortion time interval	9 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for surgical evacuation of the products of conception	how many women will undergo dilatation and curettage after failed medical induction of abortion	9 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 5, 2020
• Primary Completion (Anticipated): April 5, 2020
• Study Completion (Anticipated): April 10, 2020

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 1, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Letrozole; Misoprostol
• Other Study ID Numbers: letrozole

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No