to Study the Estimate Difficulty of Insertion Mirena IUD With Use of ProstaglandinsNCT04646161
Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
An observational study of to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins, run by Cairo University at 1 site in Egypt.
Trial summary
This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2020to 1 Mar 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female patients during the lactational amenorrhea who undergo Mirena IUD insertion after had been delivered by CS within 6 monthes
Who may be able to join
- 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders
Who cannot join
- 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 02
hany saad, assistant prof, 01001817211, hanysaad25280@gmail.com
hadeer meshaal, ass prof, 01001435238, dr_hadeer@live.com
About this study
This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,
Read the detailed description
The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins
- Being tested
- Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion
| Study group | Role | What they receive |
|---|---|---|
| prostaglandins before iud insertion group | this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion Receives: Drug: Misoprostol | |
| placebo group | this group will receive placebo tablet before mirena iud insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale
By using the visual analogue score
Measured: During the intervention
Secondary outcomes (7)
cervical dilataion < 4 mm
need for cervical dilatation to pass the IUD
Measured: During the intervention
Pain at insertion according to VAS
By using the visual analogue score
Measured: During the intervention
Subjective sensation of satisfaction graduated as VAS like scale
By using the visual analogue score like system
Measured: During the intervention
side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting
Bleeding by using the soaked bads
Measured: During the intervention
side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia
Measured: During the first 24 hours
side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion
Measured: After 30 days of intervention
Duration of insertion(min)
From start of procedure till removing the speculum
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start25 Nov 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Study the Estimate Difficulty of Insertion Mirena IUD With Use of ProstaglandinsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646161
- Sponsor's protocol ID
- professor
- Status last verified
- Jan 2021
- First submitted
- 7 Nov 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
- ClinicalTrials.gov ID
- NCT04646161
- Acronym / sponsor ID
- professor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Nov 2020 (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.
This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,
Detailed description
The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prostaglandins before iud insertion group | – | Drug: Misoprostolthis group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion |
| placebo group | – | –this group will receive placebo tablet before mirena iud insertion |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female patients during the lactational amenorrhea who undergo Mirena IUD insertion after had been delivered by CS within 6 monthes
Key inclusion criteria (1 listed)
- 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders
Key exclusion criteria (1 listed)
- 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- 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 |
|---|---|---|
| Misoprostolmisoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion | Drug | prostaglandins before iud insertion group |
Primary outcome
Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale
Time frame: During the intervention
By using the visual analogue score
7 secondary outcomes
cervical dilataion < 4 mm
Time frame: During the intervention
Pain at insertion according to VAS
Time frame: During the intervention
Subjective sensation of satisfaction graduated as VAS like scale
Time frame: During the intervention
side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting
Time frame: During the intervention
side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia
Time frame: During the first 24 hours
side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion
Time frame: After 30 days of intervention
Duration of insertion(min)
Time frame: During the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: Undecided
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?
An observational study of to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins, run by Cairo 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 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 19 Jan 2021. 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.
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 hany saad, assisstant prof (01001817211, hanysaad25280@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale (time frame: During the intervention). 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 19 Jan 2021.