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Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone

Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05940233
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT

This reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

In control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.

The primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. In control group we give only Misoprostol 800 mcg SL.We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. In control group we give only Misoprostol 800 mcg SL.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
Actual Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
May 30, 2025
Anticipated Study Completion Date :
May 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Letrozole plus Misoprostol

We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

Drug: Letrozole
In the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day.
Other Names:
  • Femara

    		•
    Active Comparator: Misoprostol

    We give only Misoprostol 800 mcg SL.

    Drug: Letrozole
    In the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day.
    Other Names:
  • Femara

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of complete abortion [up to 7 days]

      Rate of complete abortion

    Secondary Outcome Measures

    1. Side effect between both group [up to 7 days]

      Side effect between both group

    2. induced to abortion time between both group [up to 6 months]

      induced to abortion time between both group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018

    • GA <= 14 weeks

    • Os open <= 1 cm and no conceptus per os

    • Hematicrit >= 30

    • Systolic blood pressure >= 95 mmHg

    • Informed consent done and can follow up and comunicate in Thai language

    Exclusion Criteria:

    • Allerguc to Letrozole or Misoprostol

    • Intrauterine contraceptive device use

    • Breast feeding

    • Diagnoed with ectopic pregnancy or undiagnoed adnexal mass

    • Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit

    • Multiple pregnancy

    • Myoma uteri that involves the endometrium ex. Submucous myoma uteri

    • Thromboembolism or has a history of thromboembolism

    • Serum creatinine >= 2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sutinee Srimahachota Bangkok Yannawa Thailand 10120

    Sponsors and Collaborators

    • Queen Savang Vadhana Memorial Hospital, Thailand

    Investigators

    • Study Chair: ชื่นฤทัย ยี่เขียน, Ph.D., Queen Savang Vadhana Memorial Hospital, Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Queen Savang Vadhana Memorial Hospital, Thailand
    ClinicalTrials.gov Identifier:
    NCT05940233
    Other Study ID Numbers:
    • 014/2566
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Letrozole

    Study Results

    No Results Posted as of Jul 11, 2023