IUD Insertion ComplicationNCT03587077
Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section
A study testing Misoprostol and isosorbide mononitrate in people with IUD Insertion Complication, run by Assiut University.
Trial summary
The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion. 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 Complication
- What is being tested?
- Misoprostol and isosorbide mononitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to May 2019
- Phase
- Interventional
- 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
Who may be able to join
- Nonpregnant women,
- aged 18-45 years, .delivered before only by elective CS and did not receive any analgesics in the 24 h prior to IUD insertion.
Who cannot join
- Women with any uterine abnormalities as congenital anomalies,
- Women with endometrial lesions,
- Women with adenomyosis,
- Women with fibroids,
- Women with intrauterine adhesions,
- Women with chronic pelvic pain,
Show all 9Show fewer
- Women with spasmodic dysmenorrhea,
- Women with abnormal uterine bleeding,
- Women with history of cervical surgery, .Women with allergy to misoprostol or isosorbide mononitrate or any medical disease that contraindicates its use and those who refused to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Adding Vaginal Isosorbide Mononitrate to Misoprostol Prior to Intrauterine Device Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Controlled Clinical Trial
The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.
Read the detailed description
Fear of pain during insertion of an IUD may deter women from choosing the IUD as a method of contraception. According to Hubacher et al. predictors of increased pain during IUD insertion include nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding. Allen et al. predicted pain to be greater based on history of no previous vaginal delivery, and difficulty of the procedure. Pharmacological interventions for pain control during IUD insertion include analgesics, local anesthetics, and the use of prostaglandins to soften the cervix; however, there is wide variation in the use of these methods . Misoprostol has also been proposed as an agent to ease IUD insertion and decrease procedure-associated pain .
Nitrous oxide has been used for years for procedural analgesia in outpatient settings and has recently been investigated as an approach to pain management in the context of IUD insertion .
Sewell and Vincent have been offering nitrous oxide for reducing the pain of IUD insertion and have had a positive response.
- Conditions
- IUD Insertion Complication
- Being tested
- Misoprostol, Placebos, isosorbide mononitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
vaginal application
PlacebosDrug
vaginal application
isosorbide mononitrateDrug
vaginal application
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Women will receive vaginally one tablet misoprostol 200 mcg(Misotac; Sigma Pharma, SAE, EGYPT) plus one tablet isosorbide mononitrate 40 mg(Effox 40 mg; Minapharm). A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position. Receives: Drug: Misoprostol; Drug: isosorbide mononitrate |
| control group | Placebo comparator | Women will receive vaginally one tablet misoprostol 200 mcg Plus one tablet placebo.A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position. Receives: Drug: Misoprostol; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of successful IUD insertion
Defined by a distance from the IUD to the endometrial end of less than 25 mm
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for IUD Insertion ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ibrahim Ramadan Abdelrahman, Assiut University
- Investigators
- Mohamad S. Abdellah, Prof., Principal investigator, SupervisorIhab M. El-Nashar, Prof., Principal investigator, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587077
- Sponsor's protocol ID
- Pain during IUD insertion
- Status last verified
- Jun 2018
- First submitted
- 9 Apr 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akintomide H, Sewell RD, Stephenson JM. The use of local anaesthesia for intrauterine device insertion by health professionals in the UK. J Fam Plann Reprod Health Care. 2013 Oct;39(4):276-80. doi: 10.1136/jfprhc-2012-100486. Epub 2013 Feb 5.
PubMed 23385310Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
PubMed 19588429Allen RH, Carey MS, Raker C, Goyal V, Matteson K. A prospective cohort study of pain with intrauterine device insertion among women with and without vaginal deliveries. J Obstet Gynaecol. 2014 Apr;34(3):263-7. doi: 10.3109/01443615.2013.868424. Epub 2014 Jan 31.
PubMed 24483244Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.
PubMed 24012096Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.
PubMed 16824298Bahamondes L, Mansour D, Fiala C, Kaunitz AM, Gemzell-Danielsson K. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care. 2014 Jan;40(1):54-60. doi: 10.1136/jfprhc-2013-100636. Epub 2013 Sep 27.
PubMed 24076534Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65.
PubMed 21646928Carusi, D. A., & Goldberg, A. B. (2015). Intrauterine contraceptive device: insertion and removal. In: M. Zieman (Ed), UpToDate. Retrieved from http://www.uptodate.com/home .
Centers for Disease Control and Prevention. (2013). U.S. selected practice recommendations for contraceptive use, 2013: Adapted from the World Health Organization selected practice recommendations for contraceptive use. Retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr6205.pdf
d'Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 2007 Jun;75(6 Suppl):S2-7. doi: 10.1016/j.contraception.2006.12.024. Epub 2007 Apr 19.
PubMed 17531612Edmunds, M. W., & Mayhew, M. S. (2014). Pharmacology for the primary care provider (4th ed.). St. Louis, MI: Elsevier Mosby.
Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13.
PubMed 22795639Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
PubMed 24331860Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.
PubMed 20472114Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.
PubMed 17074548
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Vaginal Isosorbide Mononitrate to Misoprostol Prior to Intrauterine Device Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03587077
- Acronym / sponsor ID
- Pain during IUD insertion
- Conditions
- IUD Insertion Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 16 Jul 2018 (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.
The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.
Detailed description
Fear of pain during insertion of an IUD may deter women from choosing the IUD as a method of contraception. According to Hubacher et al. predictors of increased pain during IUD insertion include nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding. Allen et al. predicted pain to be greater based on history of no previous vaginal delivery, and difficulty of the procedure. Pharmacological interventions for pain control during IUD insertion include analgesics, local anesthetics, and the use of prostaglandins to soften the cervix; however, there is wide variation in the use of these methods . Misoprostol has also been proposed as an agent to ease IUD insertion and decrease procedure-associated pain .
Nitrous oxide has been used for years for procedural analgesia in outpatient settings and has recently been investigated as an approach to pain management in the context of IUD insertion .
Sewell and Vincent have been offering nitrous oxide for reducing the pain of IUD insertion and have had a positive response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Misoprostol, Drug: isosorbide mononitrateWomen will receive vaginally one tablet misoprostol 200 mcg(Misotac; Sigma Pharma, SAE, EGYPT) plus one tablet isosorbide mononitrate 40 mg(Effox 40 mg; Minapharm). A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position. |
| control group | Placebo comparator | Drug: Misoprostol, Drug: PlacebosWomen will receive vaginally one tablet misoprostol 200 mcg Plus one tablet placebo.A trained clinical nurse will introduce the tablets, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonpregnant women,
- aged 18-45 years, .delivered before only by elective CS and did not receive any analgesics in the 24 h prior to IUD insertion.
Key exclusion criteria (9 listed)
- Women with any uterine abnormalities as congenital anomalies,
- Women with endometrial lesions,
- Women with adenomyosis,
- Women with fibroids,
- Women with intrauterine adhesions,
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 |
|---|---|---|
| Misoprostolvaginal application | Drug | control group, study group |
| Placebosvaginal application | Drug | control group |
| isosorbide mononitratevaginal application | Drug | study group |
Primary outcome
rate of successful IUD insertion
Time frame: 10 minutes
Defined by a distance from the IUD to the endometrial end of less than 25 mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Background: PubMed 23385310Akintomide H, Sewell RD, Stephenson JM. The use of local anaesthesia for intrauterine device insertion by health professionals in the UK. J Fam Plann Reprod Health Care. 2013 Oct;39(4):276-80. doi: 10.1136/jfprhc-2012-100486. Epub 2013 Feb 5.
- Background: PubMed 19588429Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
- Background: PubMed 24483244Allen RH, Carey MS, Raker C, Goyal V, Matteson K. A prospective cohort study of pain with intrauterine device insertion among women with and without vaginal deliveries. J Obstet Gynaecol. 2014 Apr;34(3):263-7. doi: 10.3109/01443615.2013.868424. Epub 2014 Jan 31.
- Background: PubMed 24012096Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.
- Background: PubMed 16824298Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.
- Background: PubMed 24076534Bahamondes L, Mansour D, Fiala C, Kaunitz AM, Gemzell-Danielsson K. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care. 2014 Jan;40(1):54-60. doi: 10.1136/jfprhc-2013-100636. Epub 2013 Sep 27.
- Background: PubMed 21646928Barber EL, Lundsberg LS, Belanger K, Pettker CM, Funai EF, Illuzzi JL. Indications contributing to the increasing cesarean delivery rate. Obstet Gynecol. 2011 Jul;118(1):29-38. doi: 10.1097/AOG.0b013e31821e5f65.
- BackgroundCarusi, D. A., & Goldberg, A. B. (2015). Intrauterine contraceptive device: insertion and removal. In: M. Zieman (Ed), UpToDate. Retrieved from http://www.uptodate.com/home .
- BackgroundCenters for Disease Control and Prevention. (2013). U.S. selected practice recommendations for contraceptive use, 2013: Adapted from the World Health Organization selected practice recommendations for contraceptive use. Retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr6205.pdf
- Background: PubMed 17531612d'Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 2007 Jun;75(6 Suppl):S2-7. doi: 10.1016/j.contraception.2006.12.024. Epub 2007 Apr 19.
- BackgroundEdmunds, M. W., & Mayhew, M. S. (2014). Pharmacology for the primary care provider (4th ed.). St. Louis, MI: Elsevier Mosby.
- Background: PubMed 22795639Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13.
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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.
Mohamad S. Abdellah, Prof. principal investigator
Supervisor
Ihab M. El-Nashar, Prof. principal investigator
Supervisor
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and isosorbide mononitrate in people with IUD Insertion Complication, run by Assiut University.
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 2 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Eman I. Ramadan, BSc (00201063959596, emanelmelwany@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of successful IUD insertion (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03587077, which also lists 22 linked publications.
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 16 Jul 2018.