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Effectiveness of Pretreatment Letrozole Versus Misoprostol Alone in Missed Abortion

NCT04194658 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-12-13

No results posted yet for this study

Summary

Background and Rationale Abortion accounts for about 8% of maternal mortality worldwide. Surgical intervention is the definitive treatment for abortion but it is invasive. Misoprostol, a PG E1 analogue, is exten¬sively used for induction of abortion with success rate less than 90%. Estrogen is important in the maintenance of pregnancy \& aromatase enzyme is essential for its production. Letrozole is an aromatase inhibitor. So we assume that suppression of serum estradiol by letrozole will facilitate termination of pregnancy.

Objectives :

To compare the effect of a combination of letrozole with misoprostol versus misoprostol alone in successful induction of medical abortion.

Study population \& Sample size 150 women will be recruited. Women included will be \> 18 years with singleton pregnancy of gestational age ≤ 20 weeks having missed abortion. They will be excluded if they have prior CS, twin pregnancy, allergy to letrozole or liver problems.

Study Design :

A randomized controlled trial in which patients will be divided into 2 groups; case group \& control group. Each group will contain 75 patients.

Methods :

Case group will receive pretreatment letrozole 12.5 mg for 2 days while control group will receive only misoprostol. Both groups will receive misoprostol in a dosage according to the ACOG guidelines based on gestational age.

Possible Risk (s) to study population :

Major risks (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion). Minor risks (Nausea, diarrhea, headache, weakness, hot flushes).

Outcome parameter (s):

Successful medical abortion i.e. complete abortion with no need for surgical curettage within one week from the 1st dose of misoprostol.

Conditions

  • Medical; Abortion, Fetus

Interventions

DRUG

Letrozole 2.5mg

Pretreatment letrozole 12.5 mg for 2 days prior to misoprostol.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mostafa Seleem, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-31
Completion
2021-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04194658 on ClinicalTrials.gov