Cervical RipeningPhase 3NCT01156948
Misoprostol For Nulliparous Women Before Hysteroscopy
A Phase 3 study testing misoprostol and oral misoprostol in people with Cervical Ripening, run by Wenzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening
- What is being tested?
- misoprostol and oral misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.
Who cannot join
- women with a known allergy to misoprostol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 1st Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Feng Lin, MD, linfeng983023@hotmail.com
Feng Lin, MD
About this study
Official title: Comparison of Vaginal Versus Oral Misoprostol for Nulliparous Women Prior to Operative Hysteroscopy
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.
Read the detailed description
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
- Cervical Ripening
- Being tested
- misoprostol, oral misoprostol
- Keywords
- misoprostol, nulliparous, hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
400ug vaginally the day before surgery
oral misoprostolDrug
400ug misoprostol orally the day before the surgery
| Study group | Role | What they receive |
|---|---|---|
| vaginal misoprostol | Active comparator | vaginal misoprostol was administered to this group of nulliparous women Receives: Drug: misoprostol |
| oral misoprostol | Experimental | oral misoprostol Receives: Drug: oral misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical width
Measured: one day
Secondary outcomes (1)
side effects
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionAug 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Feng Lin, Principal investigator, the 1st affiliated hospital of Wenzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156948
- Sponsor's protocol ID
- WenzhouMC
- Status last verified
- May 2008
- First submitted
- 2 Jul 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Versus Oral Misoprostol for Nulliparous Women Prior to Operative Hysteroscopy
- ClinicalTrials.gov ID
- NCT01156948
- Acronym / sponsor ID
- WenzhouMC
- Conditions
- Cervical Ripening
- Keywords
- misoprostol, nulliparous, hysteroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal misoprostol | Active comparator | Drug: misoprostolvaginal misoprostol was administered to this group of nulliparous women |
| oral misoprostol | Experimental | Drug: oral misoprostoloral misoprostol |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.
Key exclusion criteria (1 listed)
- women with a known allergy to misoprostol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| misoprostol400ug vaginally the day before surgery | Drug | vaginal misoprostol |
| oral misoprostol400ug misoprostol orally the day before the surgery | Drug | oral misoprostol |
Primary outcome
cervical width
Time frame: one day
1 secondary outcome
side effects
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Lin principal investigator
the 1st affiliated hospital of Wenzhou Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing misoprostol and oral misoprostol in people with Cervical Ripening, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical width (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.