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Completed

NCT Number: NCT02401425

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

letrozole

Drug

Other names: femara

Misoprostol

Drug

Other names: Misotac; Misotec; Cytotec

Placebo

Other

Primary outcomes

  1. Incidence of complete abortion

    Time frame: 1 week

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

Secondary outcomes

  1. Need for surgical evacuation of the products of conception

    Time frame: 1 week

    Need for surgical evacuation of the products of conception

    • Incomplete expulsion of the products of conception (incomplete miscarriage).
    • Considerable bleeding necessitating immediate surgical evacuation.
  2. Maternal morbidity

    Time frame: 1 week

    Maternal morbidity

    • Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
    • Minor side effects (fever, rigors, nausea, vomiting)
  3. Hemoglobin and hematocrit deficit

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.