NCT04593108

Brief Summary

Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester. Hypothesis: Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester. Research question: Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

October 13, 2020

Last Update Submit

October 19, 2020

Conditions

Missed Abortion

Outcome Measures

Primary Outcomes (1)

  • Complete abortion

    Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.

    1week

Study Arms (2)

Letrozole misoprostol

Group (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start

Device: Letrozole misoprostol

Misoprostol,placebo

Group (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start

Drug: Misoprostol, placebo

Interventions

Letrozole misoprostolDEVICE

Letrozole give pretreatment of abortion by misoprostol

Letrozole misoprostol
Misoprostol, placeboDRUG

Give placebo pretreatment of abortion by misoprostol

Misoprostol,placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Study Settings: This clinical trial will be conducted in department of obstetrics and gynecology at Zagazig General Hospital during the period between January 2019 and June 2019. Study Population: The patients will be recruited from women attending outpatient clinic of obstetrics or the emergency room of Zagazig General Hospital.

You may qualify if:

  • Woman age more than 18 years old (age of legal consent).
  • BMI ranges between 25 kg/m2 and 35 kg/m2.
  • Gestational age of 63 days' gestation (or less).
  • Missed abortion.
  • Hemoglobin leve

You may not qualify if:

  • Woman age less than 18 years old.
  • BMI less than 25 kg/m2 or more than 35 kg/m2.
  • Gestational age more than 63 days' gestation.
  • Molar pregnancy.
  • Hemoglobin level less than 10 gm/dL.
  • Fibroid uterus.
  • Uterus with congenital anomalies.
  • Previous attempts for induction of abortion in the current pregnancy.
  • Coagulation defect i.e. coagulopathy.
  • Contraindication for induction of abortion e.g. heart failure.
  • Allergy to misoprostol or letrozole.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalia Mohammed Al Sayed Zaki

Zagazig, Sharqia Province, 1436, Egypt

Location

Related Publications (1)

  • Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.

    PMID: 21252745RESULT

Related Links

MeSH Terms

Conditions

Abortion, Missed

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Zagazig General hospital, Ministry hospital

    Zagazig general hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Banha university

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

January 15, 2019

Primary Completion

October 1, 2020

Study Completion

November 15, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations

EG(1)