Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone

NCT07767435 — Phase 1 / Phase 2, Not yet recruiting, 80 participants, Sohag University

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Termination of Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone

Registry	NCT07767435
Status	Not yet recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	Sohag University (Other)
Conditions	Abortion Induced Complicated, Abortion
Interventions	· Misoprostol + letrozole, misoprostol alone (Drug)
Dates	start 2026-08-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-08-17, last updated 2026-08-17

-Summary

Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone

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+Detailed description

An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:

* Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol.
* Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.

This study will be open-label due to different drugs and route of administrations used.

+Arms and interventions

Arm	Type	Interventions	Description
Group I (Letrozole + Misoprostol)	Active comparator	Drug: · Misoprostol + letrozole	Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol
Group II (Misoprostol alone	Active comparator	Drug: misoprostol alone	· Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.

· Misoprostol + letrozole (Drug): 1. to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy. 2. to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion.
misoprostol alone (Drug): 1. to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy. 2. to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion

+Outcome measures

Primary outcomes

· Complete abortion rate. [1 weak]

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* Pregnant women aged 18-45 years.
* Failed pregnancy.
* Gestational age between 14 and 20weeks, confirmed by ultrasonography on the day of admission.
* Hemoglobin concentration >9 g/dL.
* Closed cervix.
* Absence of products of conception in the cervical canal.

  \- Exclusion Criteria:
* Previous attempt to terminate the current pregnancy.
* Molar pregnancy (hydatidiform mole).
* Pathological uterine lesions including uterine fibroids and congenital uterine malformations.
* Cardiac disease.
* Renal disease.
* Hemorrhagic disorders.
* Body mass index (BMI) >35 kg/m².
* Documented hypersensitivity or allergy to letrozole, misoprostol, or any of the study medications.