NCT04194658

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 9, 2019

Last Update Submit

December 11, 2019

Conditions

Medical; Abortion, Fetus

Outcome Measures

Primary Outcomes (1)

  • Successful medical abortion

    Number of participants who achieved complete abortion with no need for surgical intervention in each group

    One week from the 1st dose of misoprostol.

Study Arms (2)

Case group

ACTIVE COMPARATOR

Case group will receive pretreatment letrozole 12.5 mg for 2 days before administration of misoprostol in a dosage according to ACOG guidelines based on gestational age.

Drug: Letrozole 2.5mg

Control group

NO INTERVENTION

Control group will receive only misoprostol in a dosage according to ACOG guidelines based on gestational age.

Interventions

Letrozole 2.5mgDRUG

Pretreatment letrozole 12.5 mg for 2 days prior to misoprostol.

Case group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy.
  • Primigravida or multigravida.
  • Gestational age ≤ 20 weeks.
  • Missed abortion.

You may not qualify if:

  • Maternal age \< 18 years.
  • Twin pregnancy.
  • Previous cesarean section.
  • Allergy to letrozole or misoprostol.
  • Liver cirrhosis or severe liver impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yung SSF, Lee VCY, Chiu PCN, Li HWR, Ng EHY, Yeung WSB, Ho PC. The effect of 7 days of letrozole pretreatment combined with misoprostol on the expression of progesterone receptor and apoptotic factors of placental and decidual tissues from first-trimester abortion: a randomized controlled trial. Contraception. 2016 Apr;93(4):323-330. doi: 10.1016/j.contraception.2015.12.005. Epub 2015 Dec 19.

    PMID: 26707996BACKGROUND

  • Naghshineh E, Allame Z, Farhat F. The effectiveness of using misoprostol with and without letrozole for successful medical abortion: A randomized placebo-controlled clinical trial. J Res Med Sci. 2015 Jun;20(6):585-9. doi: 10.4103/1735-1995.165964.

    PMID: 26600834BACKGROUND

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mostafa Seleem, MD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Amr Fathy, MSc

CONTACT

01018062602amrfathyz@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

December 13, 2019

Record last verified: 2019-12