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NCT Number: NCT07109947

Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage

Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospital

Aswān, Egypt

Location status: Recruiting

Location contact

Amr Shahata Abd Elbadee, Assist.Prof

CONTACT

[email protected]

+201007221659

About this study

Various medical and surgical methods have been used to manage missed abortions. Surgical methods include dilatation and curettage, and vacuum aspiration. Because these methods are expensive and involve anesthesia, however, medical methods are generally preferred over surgical methods for abortion.

Medical approaches include misoprostol which is a prostaglandin that causes myometrial contractions, cervical softening and dilatation. It is used to induce abortion and labor and to treat atonic postpartum hemorrhage and peptic ulcers.

It has the advantage of being cost-effective and stable with a low rate of side effects which has led to it being included in the World Health Organization list of essential medications (2014). Misoprostol is licensed for use to induce miscarriage in Egypt. It has not been licensed to induce labor or miscarriage in certain countries such as Germany, but it is used off-label to induce labor in the UK.

Usage of Misoprostol alone has a success rate of between 65 and 93% especially in the early stages of pregnancy. It can also use in combination with other medications such as mifepristone and methotrexate to increase the success rate.

Most studies have examined the effect of letrozole plus misoprostol on the abortion of live embryos .Given the significance of specifying an effective and safe method for termination of abortion and the specific features of letrozole, such as its safety, cost-effectiveness, and availability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Missed or anembryonic pregnancy.
  • Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance).
  • Hemoglobin level more than 9g/l.
  • Closed cervix.
  • No product of conception in the cervical canal.

Exclusion criteria

  • Previous attempt to terminate the pregnancy.
  • Molar pregnancy
  • Abnormal uterine lesions such as fibroids or congenital mal formations.
  • Pregnancy despite of intrauterine contraceptive device.
  • Medical disorders as cardiac, renal or hemorrhagic diseases.
  • BMI more than 35 kg/m2.
  • Known hypersensitivity to any of the medication used.

Treatment and study plan

Letrozole 2.5mg

Drug

to determine the effect of Letrozole as a premedication before misoprostol treatment used to induce missed miscarriage.

Other names: Misoprestol

Primary outcomes

  1. Miscarriage Achievement

    Time frame: 10 days

    The induction-to-abortion interval in each group

Study contacts

Contact information is provided by the study sponsor or research team.

Arwa Ashraf Saeed, MSC

CONTACT

[email protected]

+201013302339

Hani Ahmed Farouk, Assist.prof

CONTACT

[email protected]

+201112501460

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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