Cervical SpasmPhase 2NCT03388827
Laminaria and Misoprostol Before Operative Hysteroscopy
A Phase 2 study testing Laminaria tent and Laminaria plus Misoprostol in people with Cervical Spasm, run by Zagazig University at 1 site in Egypt.
Trial summary
Laminaria and Misoprostol before Operative Hysteroscopy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Spasm
- What is being tested?
- Laminaria tent and Laminaria plus Misoprostol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2017to Jan 2019
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- need hystroscopic intervention
Who cannot join
- cervical lesion
- contraindication to misoprostol
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig
Ibrahim A EL sharkwy, md, 00966554818576, ibrahimsharkwy@yahoo.com
Mohamed L Elsayed, md, 00201222442467, drmohamedlotfy@yahoo.com
About this study
Official title: The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.
Laminaria and Misoprostol before Operative Hysteroscopy
Read the detailed description
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
- Cervical Spasm
- Being tested
- Laminaria tent, Laminaria plus Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminaria tentDevice
Laminaria tent was inserted for 12 hours before Hysteroscopy
Laminaria plus MisoprostolDrug
Also called cytotec,
Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Laminaria | Experimental | Laminaria tent was introduced in the cervical canal Receives: Device: Laminaria tent |
| Laminaria plus Misoprostol | Active comparator | Laminaria and Misoprostol were introduced Receives: Drug: Laminaria plus Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative cervical width
cervical width in Hegar dilators number
Measured: 12 hours
Secondary outcomes (1)
adverse effects
adverse effects of the method used or hysteroscopy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start20 Dec 2017
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpasmStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM ABD ELGAFOR, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388827
- Sponsor's protocol ID
- ZUH- 9
- Status last verified
- Dec 2017
- First submitted
- 25 Dec 2017
- Last updated
- 7 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.
- ClinicalTrials.gov ID
- NCT03388827
- Acronym / sponsor ID
- ZUH- 9
- Conditions
- Cervical Spasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 3 Jan 2018 (actual)
- 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.
Laminaria and Misoprostol before Operative Hysteroscopy
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminaria | Experimental | Device: Laminaria tentLaminaria tent was introduced in the cervical canal |
| Laminaria plus Misoprostol | Active comparator | Drug: Laminaria plus MisoprostolLaminaria and Misoprostol were introduced |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- need hystroscopic intervention
Key exclusion criteria (3 listed)
- cervical lesion
- contraindication 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 |
|---|---|---|
| Laminaria tentLaminaria tent was inserted for 12 hours before Hysteroscopy | Device | Laminaria |
| Laminaria plus MisoprostolAlso: cytotec,Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy | Drug | Laminaria plus Misoprostol |
Primary outcome
Preoperative cervical width
Time frame: 12 hours
cervical width in Hegar dilators number
1 secondary outcome
adverse effects
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laminaria tent and Laminaria plus Misoprostol in people with Cervical Spasm, run by Zagazig University at 1 site in Egypt.
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 3 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 7 Dec 2018. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact ibrahim A EL sharkwy (00966554818576, ibrahimsharkwy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative cervical width (time frame: 12 hours). 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 7 Dec 2018.