Misoprostol for Second Trimester Termination of Pregnancy

NCT ID: NCT02048098

Last Updated: 2015-01-16

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

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy

Detailed Description

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Conditions

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Abortion, Induced

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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Buccal misoprostol

400 µg buccal misoprostol per 3 hours

Group Type ACTIVE_COMPARATOR

Buccal misoprostol

Intervention Type DRUG

400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.

vaginal misoprostol

400 µg vaginal misoprostol per 3 hours

Group Type ACTIVE_COMPARATOR

Vaginal misoprostol

Intervention Type DRUG

400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.

Interventions

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Vaginal misoprostol

400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.

Intervention Type DRUG

Buccal misoprostol

400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.

Intervention Type DRUG

Other Intervention Names

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Cytotec Cytotec

Eligibility Criteria

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Inclusion Criteria

* gestational age between 12-24 weeks
* live fetus
* singleton pregnancy
* Bishop score \<5
* no uterine contraction

Exclusion Criteria

* prostaglandin allergy
* a scar in uterus
* uterine abnormality
* premature rupture of membranes
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ragıp Atakan Al

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragıp A AL, MD

Role: PRINCIPAL_INVESTIGATOR

Ataturk University Faculty of Medicine

Ömer E Yapça, MD

Role: STUDY_CHAIR

Ataturk University Faculty of Medicine

Locations

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Ataturk Universitesi Araştırma Hastanesi

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Al RA, Yapca OE. Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):593-598. doi: 10.1097/AOG.0000000000000946.

Reference Type DERIVED
PMID: 26181087 (View on PubMed)

Other Identifiers

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atauni9

Identifier Type: -

Identifier Source: org_study_id

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