IUD InsertionNCT05204979
Vaginal Vs Subling Misoprost Before Iud Insertion in Women With Previous CS
An observational study of IUD Insertion, run by Ain Shams University at 1 site in Egypt.
Trial summary
Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS. 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
- IUD Insertion
- What is being tested?
- Vaginal Versus Sublingual misoprostol
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2021to 25 May 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted on multiparous women delivered only by CS seeking intra uterine device insertion
Who may be able to join
- Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30.
Who cannot join
- Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis).
- Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11865
dr h awwad, +202-24346344, dean@med.asu.edu.eg
RofIda M Taha, doctor
About this study
Official title: Vaginal Versus Sublingual Misoprostol Before Intrauterine Device Insertion in Women With Pervious Caesarian Section
Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
Read the detailed description
Intrauterine devices (IUDs) are widely used as reversible contraceptives. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally.
Misoprostol is an inexpensive PGE1. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D\&C) in premenopausal women resulted in an increased cervical dilatation and rate of cervical laceration. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. The effect of misoprostol is dependent on the route of administration. Sublingual administration of misoprostol has been shown to be more effective also for cervical priming compared with oral administration and equally effective as vaginal administration.
larger studies on the effect of misoprostol for IUD insertion are lacking. Investigator therefore will conduct a trial aiming to compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
- Conditions
- IUD Insertion
- Being tested
- Vaginal Versus Sublingual misoprostol
- Keywords
- Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Versus Sublingual misoprostolOther
Insertion failures of intra uterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. Several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
| Study group | Role | What they receive |
|---|---|---|
| Misopristol | Group A: vaginal misoprostol will be taken Group B: sublingual misoprostol will be taken Receives: Other: Vaginal Versus Sublingual misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of easy IUD Insertion
Difficulty of IUD insertion will be measured by cervical dilatation that determined by two factors:
- Degree of dilatation of cervix by using gradual Hegar 1, 2, 3.
- The degree of difficulty of the IUD insertion judged as the resistance of the internal cervical os experienced by the investigator and classified as 'easy', 'moderate' or 'difficult'.
[Time Frame: Easy: Using Hegar 3 and easy of difficulty of insertion. Moderate: Using Hegar 2 and moderate of difficulty of insertion. Difficult: Using Hegar 1 and difficult of difficulty of insertion]
Measured: 24 hours
Secondary outcomes (1)
the pain during insertion
Pain will be measured using a visual analog scale (VAS) pain score reported by participants during IUD insertion. Pain score will be measured using a visual analogue scale consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 no pain. 1-3 for mild pain. 4-6 for average pain and 7-9 for severe pain and 10 for extremely sever pain an individual can experience.
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 posted24 Jan 2022
- Study start23 Jun 2021
- Primary completion17 Feb 2022 (estimated)
- Study completion25 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD InsertionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofida Mohamed Arafa Taha, Ain Shams University
- Investigators
- Hassan MD awad, consultant, Study chair, professorRofida M Taha, doctor, Study chair, doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204979
- Sponsor's protocol ID
- THESIS FOR PARTIA
- Status last verified
- Jan 2022
- First submitted
- 23 Jun 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Versus Sublingual Misoprostol Before Intrauterine Device Insertion in Women With Pervious Caesarian Section
- ClinicalTrials.gov ID
- NCT05204979
- Acronym / sponsor ID
- THESIS FOR PARTIA
- Conditions
- IUD Insertion
- Keywords
- Misoprostol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 17 Feb 2022 (estimated)
- Study completion
- 25 May 2022 (estimated)
- First posted
- 24 Jan 2022 (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.
Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
Detailed description
Intrauterine devices (IUDs) are widely used as reversible contraceptives. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally.
Misoprostol is an inexpensive PGE1. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D\&C) in premenopausal women resulted in an increased cervical dilatation and rate of cervical laceration. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. The effect of misoprostol is dependent on the route of administration. Sublingual administration of misoprostol has been shown to be more effective also for cervical priming compared with oral administration and equally effective as vaginal administration.
larger studies on the effect of misoprostol for IUD insertion are lacking. Investigator therefore will conduct a trial aiming to compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misopristol | – | Other: Vaginal Versus Sublingual misoprostolGroup A: vaginal misoprostol will be taken Group B: sublingual misoprostol will be taken |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted on multiparous women delivered only by CS seeking intra uterine device insertion
Key inclusion criteria (1 listed)
- Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30.
Key exclusion criteria (2 listed)
- Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis).
- Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate.
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 |
|---|---|---|
| Vaginal Versus Sublingual misoprostolInsertion failures of intra uterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. Several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS. | Other | Misopristol |
Primary outcome
The proportion of easy IUD Insertion
Time frame: 24 hours
Difficulty of IUD insertion will be measured by cervical dilatation that determined by two factors: 1. Degree of dilatation of cervix by using gradual Hegar 1, 2, 3. 2. The degree of difficulty of the IUD insertion judged as the resistance of the internal cervical os experienced by the investigator and classified as 'easy', 'moderate' or 'difficult'. [Time Frame: Easy: Using Hegar 3 and easy of difficulty of insertion. Moderate: Using Hegar 2 and moderate of difficulty of insertion. Difficult: Using Hegar 1 and difficult of difficulty of insertion]
1 secondary outcome
the pain during insertion
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 24 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Hassan MD awad, consultant study chair
professor
Rofida M Taha, doctor study chair
doctor
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 IUD Insertion, 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 1 inclusion and 2 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 24 Jan 2022. 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 Rofida M Taha, doctor (+2 01284604696, RofidaMohamed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of easy IUD Insertion (time frame: 24 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 24 Jan 2022.