Anembryonic Pregnancy, Early Pregnancy Failure, Fetal Demise, Miscarriage
Conditions
Keywords
early, pregnancy, failure, mifepristone, misoprostol, buccal, miscarriage, fetal, demise, anembryonic, progesterone
Brief summary
The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there will be no difference in time to complete miscarriage between the two groups.
Detailed description
The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated efficacy at one week. We have found that many women do not want to wait for one week for an outcome of their medical treatment, and want resolution sooner. This has hampered the widespread utilization of medical therapy in our institution. We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to demonstrate the relative efficacy of two medication regimens for treatment of EPF by performing a randomized trial. One regimen will be 800μg buccal misoprostol alone and the other regimen will be 200mg mifepristone, orally, in addition to 800μg buccal misoprostol, simultaneously. The primary outcome will be complete abortion rates 24hours after medication administration. We hypothesize that mifepristone will not improve complete abortion rates at 24hrs. Secondary outcomes include rates of abortion by medical treatment at one week, the indications for surgical intervention, relationship of progesterone levels and type of pregnancy failure to outcomes in the two groups. Another secondary objective is to assess satisfaction with the treatment process at the conclusion of pregnancy termination, and 3 weeks after the beginning of the process. The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but buccal use is increasing. We will use buccal misoprostol, which is widely used at our institution. We will assess the efficacy of this route of administration as well as assess patient acceptability of this method.
Interventions
DRUGMisoprostol and placebo
Women in this group receive 800 mcg misoprostol plus a placebo
This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \>18yrs, able to read and write English * Intrauterine gestations with anembryonic sac between 10 and 45mm or * 10-15mm sac with no growth in three days or other radiologic signs of abnormal pregnancy such as irregular sac or debris within the gestational sac * An embryonic pole \<30mm with no cardiac activity
Exclusion criteria
* Intrauterine gestations with CRL \<5mm or \>30mm without cardiac activity * Incomplete abortion as defined as open cervix and large amount of cramping/bleeding * Hemodynamic instability and/or heavy vaginal bleeding * Hemoglobin less than or equal to 8 * Inability to follow-up (ie, lack of transportation or access to telephone) * Bleeding disorder or taking anticoagulants * Prior medical or surgical treatment of the current pregnancy * Obvious Infection * Active Lactation * Allergy to mifepristone or misoprostol * Chronic corticosteroid use * Severe gastrointestinal disease (e.g inflammatory bowel disease, severe gastritis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. | 24-48 hrs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Abortion at One Week | 3 weeks | Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol and Placebo Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure. | 9 |
| Mifepristone and Misoprostol Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally | 8 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Mifepristone and Misoprostol | Misoprostol and Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 17 Participants |
| Age Continuous | 29 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.
Time frame: 24-48 hrs
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Misoprostol and Placebo | Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. | 5 participants |
| Mifepristone and Misoprostol | Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. | 5 participants |
Secondary
Complete Abortion at One Week
Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound
Time frame: 3 weeks
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Misoprostol and Placebo | Complete Abortion at One Week | 6 participants |
| Mifepristone and Misoprostol | Complete Abortion at One Week | 7 participants |