Misoprostol For Nulliparous Women Before Hysteroscopy

NCT ID: NCT01156948

Last Updated: 2010-07-08

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

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

Brief Summary

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To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Detailed Description

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There is no consensus on the effect of misoprostol on cervical ripening for nulliparous women. The aim of the study is to compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Conditions

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Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vaginal misoprostol

vaginal misoprostol was administered to this group of nulliparous women

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

400ug vaginally the day before surgery

oral misoprostol

oral misoprostol

Group Type EXPERIMENTAL

oral misoprostol

Intervention Type DRUG

400ug misoprostol orally the day before the surgery

Interventions

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misoprostol

400ug vaginally the day before surgery

Intervention Type DRUG

oral misoprostol

400ug misoprostol orally the day before the surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.

Exclusion Criteria

* women with a known allergy to misoprostol.
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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the 1st Affiliated Hospital of Wenzhou Medical College

Principal Investigators

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Feng Lin

Role: PRINCIPAL_INVESTIGATOR

the 1st affiliated hospital of Wenzhou Medical College

Locations

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the 1st Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Feng Lin, MD

Role: primary

Other Identifiers

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WenzhouMC

Identifier Type: -

Identifier Source: org_study_id

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