Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Intrauterine Device

Treatments: Drug: Dinoprostone 3 mg; Drug: placebo vaginal tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03686085

vaginal dinoprostone nullipara

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 nulliparous 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.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a first line of contraception in nulliparous women.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• • a prior pregnancy greater than 20 weeks of duration

  • 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 to dinoprostone.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

dinoprostone arm

Experimental group

Description:

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.

Treatment:

Drug: Dinoprostone 3 mg

placebo

Placebo Comparator group

Description:

one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Treatment:

Drug: placebo vaginal tablet