Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss

Abortion, Missed Clinical Trial

Official title:

Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124314
• Other study ID #: 2021-0001
• Status: Recruiting
• Phase: Phase 4
• Start date: October 27, 2021
• Est. completion date: October 2023

Study information

• Verified date: November 2021
• Source: Clinical Hospital Merkur
• Contact: Mate Milas, MD
• Phone: +385992060290
• Email: milas.mate[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).

The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.

Description:

Aim: To investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss.

Primary objective: To test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss.

Secondary objectives: To test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. The investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life.

Women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. The participants will be randomized to two groups. First group will receive oral mifepristone (600 mg) and the second group will not. The remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost.

Three weeks after medical treatment, primary and secondary outcomes will be assessed. In case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed.

220 women will be randomized in a 1:1 ratio.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management

• Age 18 years and older

• Intra-uterine pregnancy

• Hemodynamically stable patient

• No signs of infection

• No signs of incomplete miscarriage

• Willing and able to give informed consent

Exclusion Criteria:

• Women opting for alternative methods of miscarriage management (expectant or surgical)

• Diagnosis of incomplete miscarriage

• Life threatening bleeding

• Hemodynamically unstable patient

• Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria

• Previous participation in this trial

• Unable to give informed consent

Related Conditions & MeSH terms

• Abortion, Missed
• Abortion, Spontaneous

Intervention

Drug:
• Mifepristone, Oral, 200 Mg
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
• Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg

Locations

Country	Name	City	State
Croatia	Clinical Hospital Merkur	Zagreb	Grad Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Hospital Merkur	University of Zagreb School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with complete evacuation of uterus	Complete evacuation of uterus will be assessed by clinical and ultrasound examination three weeks after treatment. There should be no vaginal bleeding and no suspicion of retained products of conception on ultrasound scan (endometrial thickness <= 15 mm) to declare the treatment successful.	Three weeks after randomization
Secondary	Total misoprostol dose used	Total dose of misoprostol used during treatment	Up to three weeks after randomization
Secondary	Complications	Frequency of complications (by type)	Up to three weeks after randomization
Secondary	Side effects	Type and degree of side effects experienced as reported in the patient's diary	Up to three weeks after randomization
Secondary	Duration of vaginal bleeding	Duration of vaginal bleeding as reported in the patient's diary	Up to three weeks after randomization
Secondary	Hemoglobin change	Hemoglobin change from randomization until three weeks after treatment	At randomization and three weeks after randomization
Secondary	Patient quality of life	Overall health status measured using EuroQol-5 dimensions-5 levels questionnaire's (EQ-5D-5L) VAS (visual analog scale) score ranging from 0 to 100 where 0 represents worst health the participant can imagine and 100 represents the best health the participant can imagine	At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
Secondary	Patient satisfaction	Overall patient satisfaction with the treatment measured using validated paper-based Client Satisfaction Questionnaire (CSQ-8) score ranging from 4 to 32, where higher number represents higher satisfaction	Three weeks after randomization
Secondary	Indication for surgical treatment	Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment	Three weeks after randomization