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Misopristol Versus Pitocin for Second Trimester Abortion

NCT ID: NCT00784797

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion, Missed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pitocin

high dose pitocin drip 48 hours after mifepristone preparation.

Group Type ACTIVE_COMPARATOR

mifepristone and oxytocin

Intervention Type DRUG

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

misopristol

vaginal and oral misopristol 48 hours after mifepristone preparation.

Group Type ACTIVE_COMPARATOR

mifepristone and misopristol

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

mifepristone and oxytocin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* midtrimester late abortion
* midtrimester induced abortion

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Assaf Ben Meir

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Assaf Ben-Meir, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 34061352 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27539053 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24084539 (View on PubMed)

Other Identifiers

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PitocinPGMyf-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id