Letrozole in Induction of Abortion of Anembryonic Pregnancy

Not Applicable

Completed

• Conditions: Anembryonic Pregnancy
• Interventions: Drug: Letrozole tablets; Drug: Misoprostol Tabets; Drug: Placebo tablets

• Registration Number: NCT05198050
• Lead Sponsor: Cairo University

Brief Summary

Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.

Detailed Description

Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Study Start: 2022-04-03
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• first trimester of pregnancy
• pregnancy duration less than 12 weeks based on LMP.
• non-viable fetus (blighted ovum)

Exclusion Criteria

• No heart disease,
• No asthma
• No History of thromboembolism
• No History of cancer
• No renal failure
• No liver diseases
• History of allergy to misoprostol or letrozole drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single dose letrozole tablets	Misoprostol Tabets	starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
single dose letrozole tablets	Letrozole tablets	starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
single dose letrozole tablets	Placebo tablets	starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
multiple dose letrozole tablets	Misoprostol Tabets	starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
misoprostol tablets	Misoprostol Tabets	starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
misoprostol tablets	Placebo tablets	starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
multiple dose letrozole tablets	Letrozole tablets	starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.

Primary Outcome Measures

Name	Time	Method
Complete abortion	2 days	no emergency or elective curettage was necessary until next menstruation

Secondary Outcome Measures

Name	Time	Method
Induction-to-abortion interval	2 days	the interval between administration of misoprostol)
Adverse effects of Misoprostol	2 days	diarrhea, abdominal cramps, fever and sweating.
Adverse effects of Letrozole	2 days	hot flushes, drowsiness and nausea.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt