ClinicalTrials.gg
Status unknownNCT03388827Updated Dec 7, 2018

Laminaria and Misoprostol Before Operative Hysteroscopy

A Phase 2 interventional study of Laminaria tent and Laminaria plus Misoprostol in Cervical Spasm, sponsored by Zagazig University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-07.

Sponsored by Zagazig University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

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.

02

Conditions studied

  • Cervical Spasm

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03

In context

Spasm

123 studies on the registry are indexed under Spasm; 7 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 104 interventional studies indexed under Spasm.

Browse Spasm studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: nullipara

  • need hystroscopic intervention

Exclusion Criteria: previous pregnancy

cervical lesion

to misoprostol

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Laminaria

    Laminaria tent was introduced in the cervical canal

    Device: Laminaria tent

  • Active comparator
    Laminaria plus Misoprostol

    Laminaria and Misoprostol were introduced

    Drug: Laminaria plus Misoprostol

Interventions

  • DeviceLaminaria tent

    Laminaria tent was inserted for 12 hours before Hysteroscopy

  • DrugLaminaria plus Misoprostol

    Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy

    Also known as: cytotec,

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What researchers measure

Primary outcomes

  1. Preoperative cervical width

    cervical width in Hegar dilators number

    Time frame: 12 hours

Secondary outcomes

  1. adverse effects

    adverse effects of the method used or hysteroscopy

    Time frame: 24 hours

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03388827
Lead sponsor
Zagazig University
Responsible party
IBRAHIM ABD ELGAFOR (assistant professor, Zagazig University) — Principal investigator
First posted
Jan 3, 2018
Start date
Dec 20, 2017
Primary completion
Dec 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Dec 7, 2018

Study contacts

ibrahim A EL sharkwy
Contact
ibrahimsharkwy@yahoo.com
00966554818576
mohamed L elsayed
Contact
drmohamedlotfy@yahoo.com
00201222442467

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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