NCT00784797

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

3.4 years

First QC Date

November 2, 2008

Last Update Submit

November 20, 2013

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (2)

  • Success rate of abortion

    24 hours

  • Interval to abortion

    24 hours

Secondary Outcomes (1)

  • Side effects

    24 hours

Study Arms (2)

pitocin

ACTIVE COMPARATOR

high dose pitocin drip 48 hours after mifepristone preparation.

Drug: mifepristone and oxytocin

misopristol

ACTIVE COMPARATOR

vaginal and oral misopristol 48 hours after mifepristone preparation.

Drug: mifepristone and misopristol

Interventions

mifepristone and misopristolDRUG

200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses

misopristol
mifepristone and oxytocinDRUG

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

pitocin

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • midtrimester late abortion
  • midtrimester induced abortion

You may not qualify if:

  • placenta previa
  • infected abortion
  • rupture of membranes
  • s/p cesarean section \*2 or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (3)

  • Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.

    PMID: 34061352DERIVED

  • Freeman MD, Porat N, Rojansky N, Elami-Suzin M, Winograd O, Ben-Meir A. Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester. Int J Gynaecol Obstet. 2016 Nov;135(2):154-157. doi: 10.1016/j.ijgo.2016.05.008. Epub 2016 Aug 15.

    PMID: 27539053DERIVED

  • Elami-Suzin M, Freeman MD, Porat N, Rojansky N, Laufer N, Ben-Meir A. Mifepristone followed by misoprostol or oxytocin for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):815-820. doi: 10.1097/AOG.0b013e3182a2dcb7.

    PMID: 24084539DERIVED

MeSH Terms

Conditions

Abortion, Missed

Interventions

MifepristoneOxytocin

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Assaf Ben-Meir, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 2, 2008

First Posted

November 4, 2008

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

IL(1)