IUD Insertion ComplicationPhase 2NCT03939663
Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.
A Phase 2 study testing misoprostol in people with IUD Insertion Complication, run by Ain Shams University at 1 site in Egypt.
Trial summary
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion Complication
- What is being tested?
- misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Dec 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women will be 20 to 40 years of age.
- Desires IUCD placement and able to participate.
- Negative pregnancy test.
- Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit.
- Delivered only by cesarean section.
Who cannot join
- Active cervical infection.
- Current pregnancy.
- Uterine anomaly.
- Fibroid uterus.
- Copper allergy/Wilson's disease.
- Undiagnosed abnormal uterine bleeding.
Show all 9Show fewer
- Cervical or uterine cancer.
- Allergy to misoprostol.
- Previous vaginal delivery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Enas Mahmoud
Cairo, 9999
enas mahmoud, MBBCh., 01096448037 ext. 01096448037, enasmahmoud957@yahoo.com
About this study
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.
Read the detailed description
Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.
- Conditions
- IUD Insertion Complication
- Being tested
- misoprostol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called misotac, cytotec
misoprostol 2 tablets
PlaceboDrug
starch pills manufactured to mimic misoprostol 200 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | 2 tablets vaginally Receives: Drug: Placebo |
| misoprostol group | Experimental | 400 mcg vaginally Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of failed IUCD insertions regardless of the reason .
pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale
Measured: during insertion
the degree of difficulty of the IUCD insertion .
Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale.
Measured: during insertion
Secondary outcomes (2)
heavy bleeding
heavy bleeding and blood clots
Measured: 7 days
partial or total expulsion
not insitu by U/S
Measured: 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jul 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Mahmoud Mohammed Mohammed Elshahed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939663
- Sponsor's protocol ID
- EMMMElshahed
- Status last verified
- Jun 2018
- First submitted
- 4 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.
- ClinicalTrials.gov ID
- NCT03939663
- Acronym / sponsor ID
- EMMMElshahed
- Conditions
- IUD Insertion Complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 May 2019 (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.
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.
Detailed description
Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Placebo2 tablets vaginally |
| misoprostol group | Experimental | Drug: misoprostol400 mcg vaginally |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All women will be 20 to 40 years of age.
- Desires IUCD placement and able to participate.
- Negative pregnancy test.
- Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit.
- Delivered only by cesarean section.
Key exclusion criteria (9 listed)
- Active cervical infection.
- Current pregnancy.
- Uterine anomaly.
- Fibroid uterus.
- Copper allergy/Wilson's disease.
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 |
|---|---|---|
| misoprostolAlso: misotac, cytotecmisoprostol 2 tablets | Drug | misoprostol group |
| Placebostarch pills manufactured to mimic misoprostol 200 mg tablets | Drug | placebo group |
Primary outcome
the proportion of failed IUCD insertions regardless of the reason .
Time frame: during insertion
pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale
the degree of difficulty of the IUCD insertion .
Time frame: during insertion
Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale.
2 secondary outcomes
heavy bleeding
Time frame: 7 days
partial or total expulsion
Time frame: 4 to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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 misoprostol in people with IUD Insertion Complication, run by Ain Shams 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 5 inclusion and 9 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 May 2019. 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. Some participants in this study may receive a placebo. 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 enas mahmoud, MBBCh (01096448037 ext. 01122742293, enasmahmoud957@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of failed IUCD insertions regardless of the reason . (time frame: during insertion). The study lists 2 primary outcomes in all. 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 May 2019.