Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Abortion, Missed Clinical Trial

Official title:

Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410345
• Other study ID #: mifepristoneoxytocin-HMO-CTIL
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2006
• Last updated: February 28, 2017
• Start date: August 2004
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.

Description:

The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 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

Related Conditions & MeSH terms

• Abortion, Missed

Intervention

Drug:
• Mifepristone

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 of abortion induction
Primary	abortion induction duration