Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letrozole 2.5mg.
- Who it may be relevant to
- Registry conditions: Miscarriage. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage
Overview
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.
Detailed description
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.
Interventions
- Drug Letrozole 2.5mg
to determine the effect of Letrozole as a premedication before misoprostol treatment used to induce missed miscarriage.
Primary outcome measures
- Miscarriage Achievement [Time frame: 10 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Aswan University Hospital — Aswān
Identifiers
NCT: NCT07109947 · Arwa Ashraf