Letrozole in Induction of Abortion of Anembryonic Pregnancy

Cairo University (CU)

Status: Completed

Conditions: Anembryonic Pregnancy

Treatments: Drug: Placebo tablets; Drug: Letrozole tablets; Drug: Misoprostol Tabets

Study type: Interventional

Funder types: Other

Identifiers

NCT05198050

Letrozole and abortion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups

single dose letrozole tablets

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol Tabets

Drug: Letrozole tablets

Drug: Placebo tablets

multiple dose letrozole tablets

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol Tabets

Drug: Letrozole tablets

misoprostol tablets

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol Tabets

Drug: Placebo tablets