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

Primary Purpose

Medical; Abortion, Fetus

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Letrozole
Sponsored by
Queen Savang Vadhana Memorial Hospital, Thailand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medical; Abortion, Fetus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sutinee SrimahachotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Letrozole plus Misoprostol

Misoprostol

Arm Description

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

We give only Misoprostol 800 mcg SL.

Outcomes

Primary Outcome Measures

Rate of complete abortion
Rate of complete abortion

Secondary Outcome Measures

Side effect between both group
Side effect between both group
induced to abortion time between both group
induced to abortion time between both group

Full Information

First Posted
May 24, 2023
Last Updated
June 30, 2023
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT05940233
Brief Title
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
Official Title
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical; Abortion, Fetus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Letrozole plus Misoprostol
Arm Type
Experimental
Arm Description
We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.
Arm Title
Misoprostol
Arm Type
Active Comparator
Arm Description
We give only Misoprostol 800 mcg SL.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of complete abortion
Description
Rate of complete abortion
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Side effect between both group
Description
Side effect between both group
Time Frame
up to 7 days
Title
induced to abortion time between both group
Description
induced to abortion time between both group
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sutinee Srimahachota, M.D.
Phone
0847202666
Email
srimahachota@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chuenrutai Yeekian, Ph.D.
Phone
0818624534
Email
jayeekian88@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ชื่นฤทัย ยี่เขียน, Ph.D.
Organizational Affiliation
Queen Savang Vadhana Memorial Hospital, Thailand
Official's Role
Study Chair
Facility Information:
Facility Name
Sutinee Srimahachota
City
Bangkok
State/Province
Yannawa
ZIP/Postal Code
10120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sutinee Srimahachota
Phone
0847202666
Email
srimahachota@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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