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Laminaria and Misoprostol Before Operative Hysteroscopy

NCT ID: NCT03388827

Last Updated: 2018-12-07

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-01-31

Brief Summary

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Laminaria and Misoprostol before Operative Hysteroscopy

Detailed Description

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The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

Conditions

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Cervical Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
double blinded

Study Groups

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Laminaria

Laminaria tent was introduced in the cervical canal

Group Type EXPERIMENTAL

Laminaria tent

Intervention Type DEVICE

Laminaria tent was inserted for 12 hours before Hysteroscopy

Laminaria plus Misoprostol

Laminaria and Misoprostol were introduced

Group Type ACTIVE_COMPARATOR

Laminaria plus Misoprostol

Intervention Type DRUG

Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy

Interventions

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Laminaria tent

Laminaria tent was inserted for 12 hours before Hysteroscopy

Intervention Type DEVICE

Laminaria plus Misoprostol

Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy

Intervention Type DRUG

Other Intervention Names

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cytotec,

Eligibility Criteria

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Inclusion Criteria

* need hystroscopic intervention

Exclusion Criteria

cervical lesion

contraindication to misoprostol

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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IBRAHIM ABD ELGAFOR

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig University

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ibrahim A EL sharkwy

Role: CONTACT

Phone: 00966554818576

Email: [email protected]

mohamed L elsayed

Role: CONTACT

Phone: 00201222442467

Email: [email protected]

Facility Contacts

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Ibrahim A EL sharkwy, md

Role: primary

Mohamed L Elsayed, md

Role: backup

Other Identifiers

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ZUH- 9

Identifier Type: -

Identifier Source: org_study_id