Effectiveness of combining letrozole with misoprostol compared to misoprostol alone in the medical management of missed miscarriage - A randomized control trial.

Effectiveness of combining letrozole with misoprostol compared to misoprostol alone in the medical management of missed miscarriage - A randomized control trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/035

Enrollment

Unknown

Registered

2025-09-04

Start date

2025-09-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Missed miscarriages

Interventions

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 misopro

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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 ]	—

Measure

Time frame

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 ]

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Secondary

Measure	Time frame
• 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 ]	—

Measure

Time frame

• 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 ]

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Countries

Sri Lanka

Contacts

Public ContactProf. Rasika Herath

Professor in Obstetrics & Gynecology, Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Kelaniya.

rasikaherath@kln.ac.lk+94 11 295 8039

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026