Second Trimester Labor Induction Clinical Trial
Official title:
A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion
| Verified date | December 2017 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A superior second trimester medical abortion regimen has not been identified. Studies suggest
that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest
median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of
adverse events. Narrowing the interval between the two medications without clinically
reducing effectiveness may increase access and acceptability for patients and reduce costs.
Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between
mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no
studies on shorter intervals with same day administration between mifepristone and
misoprostol in second trimester abortions.
The primary objective is to assess the efficacy of the combined mifepristone/misoprostol
regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8
hours between the two medications.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - English-speaking women - 18 years of age and above - Voluntarily choose to undergo pregnancy termination via labor induction - An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation - Able to provide written consent Exclusion Criteria: - Premature rupture of membranes - Preterm labor - Intrauterine fetal demise - Chronic systemic corticosteroid use or adrenal disease - Hypersensitivity to prostaglandins - Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure - Known coagulopathy or treatment with anticoagulants - Prior caesarean delivery or myomectomy - Placenta previa |
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University | University of Maryland |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Abortion rate | 8 hours after misoprostol administration |