Misopristol Versus Pitocin for Second Trimester Abortion

Abortion, Missed Clinical Trial

Official title:

Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784797
• Other study ID #: PitocinPGMyf-HMO-CTIL
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2008
• Last updated: November 20, 2013
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• midtrimester late abortion

• midtrimester induced abortion

Exclusion Criteria:

• placenta previa

• infected abortion

• rupture of membranes

• s/p cesarean section *2 or more

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Missed

Intervention

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
• mifepristone and oxytocin
200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of abortion		24 hours	No
Primary	Interval to abortion		24 hours	No
Secondary	Side effects		24 hours	No