Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: IUD Insertion

Treatments: Drug: Dinoprostone; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04046302

dinoprostone IUD pain

Details and patient eligibility

About

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Full description

Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Enrollment: 160 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.

Exclusion criteria

• currently pregnant or were pregnant within 6 weeks of study entry
• had a prior attempted or successful IUD insertion
• had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
• any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
• active vaginitis or cervicitis
• undiagnosed abnormal uterine bleeding
• pelvic inflammatory disease within the last 3 months
• fibroids or other uterine abnormalities distorting the uterine cavity
• contraindication or allergy to dinoprostone.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

dinoprostone

Experimental group

Description:

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Treatment:

Drug: Dinoprostone

placebo

Placebo Comparator group

Description:

one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Treatment:

Drug: placebo