Misopristol Versus Pitocin for Second Trimester Abortion
|ClinicalTrials.gov Identifier: NCT00784797|
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : November 21, 2013
Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.
Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.
|Condition or disease||Intervention/treatment||Phase|
|Abortion, Missed||Drug: mifepristone and misopristol Drug: mifepristone and oxytocin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion|
|Study Start Date :||January 2009|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Active Comparator: pitocin
high dose pitocin drip 48 hours after mifepristone preparation.
Drug: mifepristone and oxytocin
200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)
Active Comparator: misopristol
vaginal and oral misopristol 48 hours after mifepristone preparation.
Drug: mifepristone and misopristol
200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses
- Success rate of abortion [ Time Frame: 24 hours ]
- Interval to abortion [ Time Frame: 24 hours ]
- Side effects [ Time Frame: 24 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784797
|Hadassah Medical Organization|
|Principal Investigator:||Assaf Ben-Meir, MD||Hadassah Medical Organization|