Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal

• ClinicalTrials.gov Identifier: NCT03600064
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Last Update Posted: September 16, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohammed Khairy Ali, Assiut University

Tracking Information

• First Submitted Date: July 17, 2018
• First Posted Date: July 26, 2018
• Last Update Posted Date: September 16, 2020
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: July 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 14, 2020)

The degree of pain perception immediate after intrauterine device removal measured by Visual analogue scale [ Time Frame: 1 minute ]

visual analogue scale from 0 to 10 score (0 means no pain, 10 means maximum pain)

• Original Primary Outcome Measures (submitted: July 17, 2018): Visual analogue scale score (VAS) immediate after intrauterine device removal [ Time Frame: 1 minute ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal
• Official Title: Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal in Women Delivered Only by Elective Cesarean Section

Brief Summary

Intrauterine devices are the most common used method of contraception in the world, mostly in developing countries, because they offer long-term, reversible and relatively safe contraception. At present, 50% of intrauterine devices users are women of reproductive age and most of them are requesting Intrauterine device removal to regain their fertility. In general, an intrauterine device should be removed during menses or preferably immediate after menses because intrauterine device removal is usually easy because the cervix is still soft.

The intrauterine device is usually removed by firmly grasping the threads at the external os; traction should be applied away from the cervix. If resistance is present, the removal should be stopped until it is determined why the intrauterine device is not moving. Some deeply embedded intrauterine device may need to be removed by hysteroscope [4].

In practice, many women, however, have an intolerable pain during intrauterine device removal and some of them requesting painkiller or even anesthesia to allow the physician to remove it. Cervical hardening and adhesions are the major factors making IUD removal difficult especially in post-menopausal women.

Insertion and removal of IUD in nulliparous women is possible but it may carry more pain, more difficulty than in parous women. We think that this problem is also present in women has no vagina delivery before. So, the intrauterine device removal actually has some difficulty or pain in the nulliparous women, women delivered by elective caesarian section or postmenopausal women.

Many medical agents for cervical ripening prior to the removal have been emerged like misoprostol. Misoprostol is commonly used for cervical ripening in the first and second trimester miscarriage and prior intrauterine devices insertion. The use of vaginal misoprostol before intrauterine device insertion in women who had never delivered vaginally before may increase the ease and success of insertion with pain felt during the procedure .

However and up to our knowledge; no studies had been reported the effect of misoprostol on removal pain in women delivered only by elective cesarean section.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Intrauterine Device

Intervention

Drug: Misoprostol

the women will be received two tablets of misoprostol 400 mcg vaginally before IUD removal (Misotac®; Sigma Pharma, SAE, Egypt).

Study Arms

• Misoprostol group
  Intervention: Drug: Misoprostol
• No Intervention: NO intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 17, 2018): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 1, 2020
• Actual Primary Completion Date: July 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Aged 18-45 years
2. Menstruating women
3. Nonpregnant women
4. Delivered before only by elective cesarean section
5. Women who did not receive any analgesics in the 24 h prior to Intrauterine device removal.
6. Using copper 380 A Intrauterine device for contraception only
7. Requesting Intrauterine device removal for returning of fertility

Exclusion Criteria:

1. Women with allergy to misoprostol or any medical disease that contraindicates its use
2. Ultrasonographic evidence of displaced Intrauterine device.
3. Women who will refuse to participate in the study.
4. Women who had any other type of Intrauterine device.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03600064
• Other Study ID Numbers: MIUD
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Mohammed Khairy Ali, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: September 2020