Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

NCT04590482 | Unknown Phase 4

• 1 other identifier: Letrozole /pretreatment
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Conditions

Missed Abortion

Outcome Measures

Primary Outcomes (1)

• Complete abortion

  incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol

  6 hours

Secondary Outcomes (1)

• surgical evacuation

  6 hours

Study Arms (2)

letrozole then misoprostol

EXPERIMENTAL

description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed

Drug: letrozole

placebo then misoprostol

PLACEBO COMPARATOR

Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed

Drug: placebo

Interventions

letrozole DRUG

Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion

letrozole then misoprostol

placebo DRUG

placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

placebo then misoprostol

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Ages of eligibility :18years and older sex eligibility :female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Maternal age more than 18 years old.
• Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
• Hemoglobin \>10 g/dl
• Missed abortion

You may not qualify if:

• Mullerian Uterine anomalies as septate, bicornuate uterus.
• Fibroid uterus.
• Coagulopathy.
• Medical disorder that contraindicate induction of abortion.
• Allergy to misoprostol or letrozole.

Sponsors & Collaborators

• Shereen Rady Abou El-fetouh: lead

MeSH Terms

Conditions

Abortion, Missed

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• shereen khedr

  AinShams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shereen khedr

CONTACT

01011304478; a.m.agdy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participant- care provider -investigator- outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: October 19, 2020
• Study Start: November 15, 2020
• Primary Completion: March 16, 2021
• Study Completion: May 8, 2021
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share