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

Clinical Hospital Merkur

Status and phase

Unknown

Phase 4

Conditions

Abortion, Missed

Treatments

Drug: Misoprostol Pill

Drug: Mifepristone, Oral, 200 Mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05124314

2021-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

Mifepristone and Misoprostol

Experimental group

Description:

Patients receive oral mifepristone (600 mg) 48 hours before medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).

Treatment:

Drug: Mifepristone, Oral, 200 Mg

Drug: Misoprostol Pill

Misoprostol

Active Comparator group

Description:

Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).

Treatment:

Drug: Misoprostol Pill