Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage

NCT ID: NCT07160855

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2025-11-12

Brief Summary

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The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).

The main questions this study aims to answer are:

1. Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
2. Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage.

ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.

What Will Happen in the Study A total of 92 women will take part.

Participants will be randomly assigned to one of two groups:

Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.

Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.

Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.

Products of conception will be examined to confirm abortion.

Detailed Description

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Conditions

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Miscarriage in First Trimester Missed Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Misoprostol with placebo

Vaginal Misoprostol will be instituted after oral placebo

Group Type ACTIVE_COMPARATOR

Misoprostol (given vaginally)

Intervention Type DRUG

800 micrograms of a single dose of vaginal misoprostol will be given

Placebo

Intervention Type DRUG

oral placebo for three days will be given

Misoprostol with Letrozole

After oral letrozole, vaginal Misoprostol will be instituted

Group Type EXPERIMENTAL

Misoprostol (given vaginally)

Intervention Type DRUG

800 micrograms of a single dose of vaginal misoprostol will be given

Letrozole 5 mg

Intervention Type DRUG

10 mg oral letrozole for 3 days will be given

Interventions

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Misoprostol (given vaginally)

800 micrograms of a single dose of vaginal misoprostol will be given

Intervention Type DRUG

Letrozole 5 mg

10 mg oral letrozole for 3 days will be given

Intervention Type DRUG

Placebo

oral placebo for three days will be given

Intervention Type DRUG

Other Intervention Names

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Cytotec Arthrotec femara

Eligibility Criteria

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Inclusion Criteria

* Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
* Single intrauterine pregnancy
* Planned for termination due to missed miscarriage

Exclusion Criteria

* Previous history of cesarean section
* Uterine scar due to previous procedure like myomectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nishtar Medical University

OTHER

Sponsor Role lead

Responsible Party

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Afrayshum Tariq

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rabia R Assistant Professor, FCPS

Role: STUDY_CHAIR

Nishtar Medical University and Hospital

Locations

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Nishtar Medical University and Hospital

Multan, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Afrayshum T Principal Investigator, MBBS

Role: CONTACT

+92 3336239197

Facility Contacts

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Afrayshum T Principal Investigator, MBBS

Role: primary

+92 3336239197

Rabia R Assistant Professor, FCPS

Role: backup

+92 3027336131

References

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Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.

Reference Type BACKGROUND
PMID: 30647756 (View on PubMed)

Other Identifiers

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U1111-1327-5077

Identifier Type: -

Identifier Source: org_study_id

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