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Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04590482
Enrollment
110
Registered
2020-10-19
Start date
2020-11-15
Completion date
2021-05-08
Last updated
2020-10-29

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

Conditions

Missed Abortion

Brief summary

this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Detailed description

Intervention type: drug Intervention name: letrozole then misoprostol Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion Arm group label:study group Intervention type :drug Intervention name:placebo then misoprostol Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion Arm group label: control group

Interventions

DRUGletrozole

Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion

DRUGplacebo

placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

Sponsors

Shereen Rady Abou El-fetouh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

participant- care provider -investigator- outcomes assessor

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

1. Maternal age more than 18 years old. 2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study. 3. Hemoglobin \>10 g/dl 4. Missed abortion

Exclusion criteria

1. Mullerian Uterine anomalies as septate, bicornuate uterus. 2. Fibroid uterus. 3. Coagulopathy. 4. Medical disorder that contraindicate induction of abortion. 5. Allergy to misoprostol or letrozole. \-

Design outcomes

Primary

MeasureTime frameDescription
Complete abortion6 hoursincidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol

Secondary

MeasureTime frameDescription
surgical evacuation6 hourssurgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol

Contacts

Primary Contactshereen khedr
a.m.agdy@hotmail.com01011304478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026