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Completed

NCT Number: NCT03600064

Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Misoprostol

Drug

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

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal in Women Delivered Only by Elective Cesarean Section

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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