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Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal

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

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.


Condition or disease Intervention/treatment Phase
Intrauterine Device Drug: Misoprostol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal in Women Delivered Only by Elective Cesarean Section
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Misoprostol group Drug: Misoprostol
the women will be received two tablets of misoprostol 400 mcg vaginally before IUD removal (Misotac®; Sigma Pharma, SAE, Egypt).

No Intervention: NO intervention



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600064


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03600064    
Other Study ID Numbers: MIUD
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics