Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03628625

Enrollment

Registered

2018-08-14

Start date

2018-09-10

Completion date

2018-12-10

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage, Missed Abortion

Brief summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed description

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week letrozole administration with misoprostol raises the rate of complete abortion Hypothesis: In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Interventions

DRUGLetrozole 2.5mg

total dose 7.5 mg per day for 3 days

DRUGPlacebo

Folic acid for 3 days

DRUGMisoprostol

Misoprosrol 800mcg will be given to all patients for induction of abortion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Gestational age less than 64 days gestation (\<9 wks). * Hemoglobin \>10 g/dL. * BMI between 18.5 kg/m2 and 25 kg/m2. * Missed abortion.

Exclusion criteria

* Molar pregnancy. * Fibroid uterus. * Uterine anomalies. * Coagulopathy. * Medical disorder that contraindicate induction of abortion (e.g. heart failure). * Previous attempts for induction of abortion in the current pregnancy. * Allergy to misoprostol or letrozole.

Design outcomes

Primary

Measure	Time frame
Incidence of complete miscarriage	6 hours

Secondary

Measure	Time frame
Need for surgical evacuation of the products of conception	6 hours
Incidence of Septic Abortion	1 week

Countries

Egypt

Contacts

Primary ContactDina Mansour

Dinayahiamansour@hotmail.com+20100657

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026