Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal

NCT ID: NCT03600064

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-09-01

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.

Conditions

Intrauterine Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Misoprostol group

Group Type: OTHER

Misoprostol

Intervention Type: DRUG

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

NO intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Misoprostol

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

MIUD

Identifier Type: -

Identifier Source: org_study_id