Contraceptive Device; ComplicationsPhase 4NCT03081442
Vaginal Misoprostol Before IUD Insertion in Women With Cesarean Scar
A Phase 4 study testing Misoprostol and Intrauterine contraceptive device IUCD in people with Contraceptive Device; Complications, run by Cairo University at 1 site in Egypt.
Trial summary
Groups of study: 120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion. Group 2: Sixty women received the placebo vaginally. Read more about this study
- Who is it for?
- Ages 19 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Device; Complications
- What is being tested?
- Misoprostol and Intrauterine contraceptive device IUCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2017to 1 Nov 2017
- Phase
- Phase 4
- 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 19 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with previous cesarean section and with no previous vaginal delivery attending outpatient clinic for IUD insertion
Who cannot join
- contraindications for misoprostol use (pregnancy and prostaglandin allergy).
- contraindications for IUD use (gynecologic malignancy, pelvic inflammatory disease and unexplained vaginal bleeding).
- previous vaginal delivery. And (4) medical disorders as diabetes, hypertension and bleeding tendency .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Use of 600 Microgram Misoprostol Vaginally Prior To Insertion Of An Intrauterine Device in Patients With Cesarean Scar: A Randomized Controlled Trial
Groups of study:
120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Read more
Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.
Methodology:
All patients were subjected to the following:
(i) Complete history taking (ii) Proper counseling: (iv) Examination: (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo were administered Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist .
(vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken , Proper counseling, Informed consent is taken from each patients, examination ( general , abdominal and pelvic )to exclude any pathology .
A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution.
The Next step was to sound and measure the depth of the uterus. The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward to straighten the angle of flection.
The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange.
The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .
The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the external cervical os.
Read the detailed description
Groups of study:
120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.
Methods of randomization:
To insure that everyone had an equal chance of participation, randomization was guided by table of random numbers using computer generated system(SPSS: windous version8) (SPSS Inc., Chicago, USA) double blinding technique was used thus; the investigator and the patient didn't know the group to which the patient was allocated.
Methodology:
All patients were subjected to the following:
(i) Complete history taking:
- Full history taking.
- Obstetric history.
- Menstrual history.
- Medical history. Data were collected in a special form for each patient. (ii) Proper counseling: Proper counseling of each patient about different types of IUDs, the advantage and side effects of each type, explanation of the menstrual pattern changes, assuring the patient that these changes are very common and that it will disappear after a period of time after insertion. (iii) Consent: Informed consent is taken from each patients . (iv) Examination:
- General examination.
- Abdominal examination.
- Pelvic examination to exclude pelvic pathology . (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo ( stugeron®, Mina Pharm. under licence Janssen Pharmaceutica, Egypt ) were administered Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist . (vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken , Proper counseling, Informed consent is taken from each patients, examination ( general , abdominal and pelvic )to exclude any pathology . A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution. The Next step was to sound and measure the depth of the uterus. The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward to straighten the angle of flection. The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange. The outer sheath of the insert was withdrawn ashort distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus . The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the external cervical os. Post insertion instructions: Palpation of strings should be performed monthly by the patient to verify continuing presence of the IUD after each menstrual flow. Caution the patient that the first 2 menses are typically heavier.
- Conditions
- Contraceptive Device; Complications
- Being tested
- Misoprostol, Intrauterine contraceptive device IUCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called cytotec
600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion
Intrauterine contraceptive device IUCDDevice
Also called TCu-380A®,Pregna International Ltd, India
bimanual examination. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution.
The Next step was to sound The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange.
The outer sheath of the insert was withdrawn ashort distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol group | Active comparator | Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion. Receives: Drug: Misoprostol; Device: Intrauterine contraceptive device IUCD |
| placebo group | Placebo comparator | Sixty women received the placebo vaginally six hours before IUD insertion. Placebo is the same in size, color and shape to misoprostol. Receives: Device: Intrauterine contraceptive device IUCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain scores were measured by Visual analogue scale (VAS) consists of 10 cm horizontal straight line with 2 ends At 0 end there was no pain and at 10 there was a severe pain
Measured: At time of insertion
Secondary outcomes (2)
Difficulty of insertion of IUD in both groups
Difficulty of IUD insertion was measured by a 10-point scale, on which 0 represented an extremely easy, and 10 an extremely difficult insertion
Measured: At time of insertion
side effects
abdominal cramps, headache, nausea, diarrhea and fever
Measured: from time of administration till insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start11 Apr 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive Device; ComplicationsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081442
- Sponsor's protocol ID
- 159
- Status last verified
- Nov 2017
- First submitted
- 10 Mar 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Use of 600 Microgram Misoprostol Vaginally Prior To Insertion Of An Intrauterine Device in Patients With Cesarean Scar: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03081442
- Acronym / sponsor ID
- 159
- Conditions
- Contraceptive Device; Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 16 Mar 2017 (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.
Groups of study:
120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.
Methodology:
All patients were subjected to the following:
(i) Complete history taking (ii) Proper counseling: (iv) Examination: (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo were administered Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist .
(vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken , Proper counseling, Informed consent is taken from each patients, examination ( general , abdominal and pelvic )to exclude any pathology .
A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution.
The Next step was to sound and measure the depth of the uterus. The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward to straighten the angle of flection.
The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange.
The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .
The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the external cervical os.
Detailed description
Groups of study:
120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.
Methods of randomization:
To insure that everyone had an equal chance of participation, randomization was guided by table of random numbers using computer generated system(SPSS: windous version8) (SPSS Inc., Chicago, USA) double blinding technique was used thus; the investigator and the patient didn't know the group to which the patient was allocated.
Methodology:
All patients were subjected to the following:
(i) Complete history taking:
- Full history taking.
- Obstetric history.
- Menstrual history.
- Medical history. Data were collected in a special form for each patient. (ii) Proper counseling: Proper counseling of each patient about different types of IUDs, the advantage and side effects of each type, explanation of the menstrual pattern changes, assuring the patient that these changes are very common and that it will disappear after a period of time after insertion. (iii) Consent: Informed consent is taken from each patients . (iv) Examination:
- General examination.
- Abdominal examination.
- Pelvic examination to exclude pelvic pathology . (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo ( stugeron®, Mina Pharm. under licence Janssen Pharmaceutica, Egypt ) were administered Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist . (vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken , Proper counseling, Informed consent is taken from each patients, examination ( general , abdominal and pelvic )to exclude any pathology . A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution. The Next step was to sound and measure the depth of the uterus. The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward to straighten the angle of flection. The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange. The outer sheath of the insert was withdrawn ashort distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus . The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the external cervical os. Post insertion instructions: Palpation of strings should be performed monthly by the patient to verify continuing presence of the IUD after each menstrual flow. Caution the patient that the first 2 menses are typically heavier.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol group | Active comparator | Drug: Misoprostol, Device: Intrauterine contraceptive device IUCDSixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion. |
| placebo group | Placebo comparator | Device: Intrauterine contraceptive device IUCDSixty women received the placebo vaginally six hours before IUD insertion. Placebo is the same in size, color and shape to misoprostol. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with previous cesarean section and with no previous vaginal delivery attending outpatient clinic for IUD insertion
Key exclusion criteria (3 listed)
- contraindications for misoprostol use (pregnancy and prostaglandin allergy).
- contraindications for IUD use (gynecologic malignancy, pelvic inflammatory disease and unexplained vaginal bleeding).
- previous vaginal delivery. And (4) medical disorders as diabetes, hypertension and bleeding tendency .
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: cytotec600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion | Drug | Misoprostol group |
| Intrauterine contraceptive device IUCDAlso: TCu-380A®,Pregna International Ltd, Indiabimanual examination. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution. The Next step was to sound The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange. The outer sheath of the insert was withdrawn ashort distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus . | Device | Misoprostol group, placebo group |
Primary outcome
Pain score
Time frame: At time of insertion
Pain scores were measured by Visual analogue scale (VAS) consists of 10 cm horizontal straight line with 2 ends At 0 end there was no pain and at 10 there was a severe pain
2 secondary outcomes
Difficulty of insertion of IUD in both groups
Time frame: At time of insertion
side effects
Time frame: from time of administration till insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- 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.
Ahmed Maged principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol and Intrauterine contraceptive device IUCD in people with Contraceptive Device; Complications, 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 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: finished, as of the sponsor's last update on 6 Nov 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: At time of insertion). 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 6 Nov 2017.