Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial

The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Study Overview

• Status: Completed
• Conditions: Complete Miscarriage
• Intervention / Treatment: Other: Placebo; Drug: Letrozole; Drug: Misoprostol

Detailed Description

Primary outcome:

Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)

Secondary outcome:

Need for surgical evacuation of the products of conception

• Incomplete expulsion of the products of conception (incomplete miscarriage).
• Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
• Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
• Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Maternal age more than 18 years old (age of legal consent).
• Gestational age less than 13 weeks.
• Hemoglobin >10 g/dL.
• BMI between 25 kg/m2 and 35 kg/m2.
• Missed abortion.
• Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

• Maternal age less than 18 years old.
• Gestational age more than 12 weeks.
• Hemoglobin <10 g/dL.
• Anencephaly.
• Fibroid uterus.
• BMI less than 25kg/m2 and more than 35kg/m2.
• Coagulopathy.
• History or evidence of adrenal pathology.
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or letrozole.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: letrozole; Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.	Drug: Letrozole; Other Names: femara; Drug: Misoprostol; Other Names: Misotac; Misotec; Cytotec
Placebo Comparator: placebo; Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.	Other: Placebo; Drug: Misoprostol; Other Names: Misotac; Misotec; Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complete abortion	complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for surgical evacuation of the products of conception	Need for surgical evacuation of the products of conception; Incomplete expulsion of the products of conception (incomplete miscarriage).; Considerable bleeding necessitating immediate surgical evacuation.	1 week
Maternal morbidity	Maternal morbidity; Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion); Minor side effects (fever, rigors, nausea, vomiting)	1 week
Hemoglobin and hematocrit deficit		1 week

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 27, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Misoprostol; Letrozole; First-Trimester; Pretreatment
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; 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: 1984