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
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 .
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
the women will be received two tablets of misoprostol 400 mcg vaginally before IUD removal (Misotac®; Sigma Pharma, SAE, Egypt).
|No Intervention: NO intervention|
- 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)
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
|Women Health Hospital - Assiut university|
|Assiut, Egypt, 71111|