Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

NCT03628625 | Unknown Phase 2

• 1 other identifier: 0005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Conditions

Miscarriage; Missed Abortion

Outcome Measures

Primary Outcomes (1)

• Incidence of complete miscarriage

  6 hours

Secondary Outcomes (2)

• Need for surgical evacuation of the products of conception

  6 hours

• Incidence of Septic Abortion

  1 week

Study Arms (2)

Study group

EXPERIMENTAL

3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.

Drug: Letrozole 2.5mg; Drug: Misoprostol

Control group

PLACEBO COMPARATOR

three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses

Drug: Placebo; Drug: Misoprostol

Interventions

Letrozole 2.5mg DRUG

total dose 7.5 mg per day for 3 days

Study group

Placebo DRUG

Folic acid for 3 days

Control group

Misoprostol DRUG

Misoprosrol 800mcg will be given to all patients for induction of abortion

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age less than 64 days gestation (\<9 wks).
• Hemoglobin \>10 g/dL.
• BMI between 18.5 kg/m2 and 25 kg/m2.
• Missed abortion.

You may not qualify if:

• Molar pregnancy.
• Fibroid uterus.
• Uterine anomalies.
• Coagulopathy.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or letrozole.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University, Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous; Abortion, Missed

Interventions

Letrozole; Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Dina Mansour

CONTACT

+20100657; Dinayahiamansour@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology Ain Shams University

Model Details: Randomized

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: August 14, 2018
• Study Start: September 10, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 10, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

EG (1)