Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

Dr.Dalia Mohammed Al Sayed Zaki

Status: Unknown

Conditions: Missed Abortion

Treatments: Device: Letrozole misoprostol; Drug: Misoprostol, placebo

Study type: Observational

Funder types: Other

Identifiers

NCT04593108

Treatment of missedmiscarriage

Details and patient eligibility

About

Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Full description

Aim of the Work

Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Primary outcome:

Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.

Secondary outcome:

• Curettage (surgical evacuation of the products of conception)

• Incomplete abortion (retained products of conception).
• Considerable bleeding that necessitates immediate evacuation.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Woman age more than 18 years old (age of legal consent).
• BMI ranges between 25 kg/m2 and 35 kg/m2.
• Gestational age of 63 days' gestation (or less).
• Missed abortion.
• Hemoglobin leve

Exclusion criteria

• Woman age less than 18 years old.
• BMI less than 25 kg/m2 or more than 35 kg/m2.
• Gestational age more than 63 days' gestation.
• Molar pregnancy.
• Hemoglobin level less than 10 gm/dL.
• Fibroid uterus.
• Uterus with congenital anomalies.
• Previous attempts for induction of abortion in the current pregnancy.
• Coagulation defect i.e. coagulopathy.
• Contraindication for induction of abortion e.g. heart failure.
• Allergy to misoprostol or letrozole.

Trial design

320 participants in 2 patient groups

Letrozole misoprostol

Description:

Group (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start

Treatment:

Device: Letrozole misoprostol

Misoprostol,placebo

Description:

Group (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start

Treatment:

Drug: Misoprostol, placebo