Home » Trials » SLCTR/2025/035
Effectiveness of combining letrozole with misoprostol compared to misoprostol alone in the medical management of missed miscarriage - A randomized control trial
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SLCTR Registration Number
SLCTR/2025/035
Date of Registration
The date of last modification
Sep 04, 2025
Scientific Title of Trial
Effectiveness of combining letrozole with misoprostol compared to misoprostol alone in the medical management of missed miscarriage - A randomized control trial
Public Title of Trial
Effectiveness of combining letrozole with misoprostol compared to misoprostol alone in the medical management of missed miscarriage - A randomized control trial.
Disease or Health Condition(s) Studied
Missed miscarriages
Scientific Acronym
Public Acronym
Brief title
Effectiveness of Letrozole in managing missed miscarriage
Universal Trial Number
U1111-1321-8007
Any other number(s) assigned to the trial and issuing authority
P/32/03/2025 (Faculty of Medicine, Kelaniya)
What is the research question being addressed?
Will combining letrozole with misoprostol compared to misoprostol alone be effective in the medical management of missed miscarriage?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: Ward 24, Professorial Unit of Colombo North Teaching Hospital. Method of randomization: block randomization. Group 1: Letrozole 10 mg orally twice daily for 3 days, followed by misoprostol 800 mcg vaginally every 3 hours (max 2 doses). Group 2: Misoprostol 800 mcg vaginally every 3 hours (max 2 doses).
Inclusion criteria
• Women aged 18–45 years. • Ultrasound-confirmed diagnosis of missed miscarriage (gestational age ?12 weeks on USS assessment). • Willingness to provide informed consent
Exclusion criteria
• Patients with features suggestive of septic miscarriage. • Hemodynamic instability at the time of recruitment. • Patients with bleeding disorders or those on anticoagulants • History of hypersensitivity to letrozole or misoprostol. • Severe anemia (hemoglobin <8 g/dL). • Uterine Fibroids types 0 to 3 • Other significant uterine anomalies (Eg Bicornuate Uterus)
Primary outcome(s)
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1.
Rate of complete expulsion of retained products of conception confirmed (RPOC) via trans-vaginal ultrasound (TVS) 24 hours after treatment initiation. The following TVS scan criteria will be used to assess success vs failure: • If retained RPOC is less than 15 mm and the patient is hemodynamically stable without any active bleeding, treatment will be considered successful. • If the Gestational sac is still visible, management will be considered unsuccessful, and surgical management will be considered. • If the USS finding demonstrates RPOC of more than 15mm, the treatment is considered to be unsuccessful, following which surgical management will be considered. All participants will be reassessed with urine HCG in 3 weeks following discharge. Urine HCG-positive participants will be further evaluated for possible causes (etc. Gestational trophoblastic disease, Heterotopic pregnancy, incomplete surgical evacuation). Proportion of patients with TVS criteria for complete expulsion of RPOC and a negative urine HCG will be used as primary outcome. |
[ 24 hours after completing medical management and at 3 weeks post procedure ] |
Secondary outcome(s)
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1.
• Pain assessment using a visual analog scale (VAS) after 24 hours of misoprostol administration • Satisfaction survey on the treatment process using a 5-point Likert scale • Development of Complications assessed as follows - 1. Development of Pain – VAS, 2. Development of bleeding – Pictorial blood assessment chart, 3. Any other complications will be documented by the interviewer as a free text. |
[ 24 hours after completing medical management and at 3 weeks post procedure ] |
Target number/sample size
134 (67 om each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-09-20
Anticipated end date
2027-09-20
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
The principal investigator is planning to apply for grants for strengthening research outputs from the grants scheme of the Research Council, University of Kelaniya.
Regulatory approvals
Status
Approved
Date of Approval
2025-05-14
Approval number
P/32/03/2025
Details of Ethics Review Committee
| Name: | Ethics review committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | Faculty of Medicine, University of Kelaniya, PO box 6, Thalagolla road, Ragama |
| Telephone: | +94 11 2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Rasika Herath
Professor in Obstetrics & Gynecology, Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Kelaniya.
Faculty of Medicine, University of Kelaniya, PO box 6, Thalagolla road, Ragama
+94 11 295 8039
?+94 (77) 368 7935?
rasikaherath@kln.ac.lk
rasikaherath@kln.ac.lk
Contact Person for Public Queries
Prof. Rasika Herath
Professor in Obstetrics & Gynecology, Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Kelaniya.
Faculty of Medicine, University of Kelaniya, PO box 6, Thalagolla road, Ragama
+94 11 295 8039
?+94 (77) 368 7935?
rasikaherath@kln.ac.lk
rasikaherath@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
