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

Phase 3

Completed

• Conditions: Intrauterine Device
• Interventions: Drug: placebo vaginal tablet; Drug: Dinoprostone 3 mg

• Registration Number: NCT03686085
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Study Start: 2018-09-30
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-28
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Provider ease of insertion	5 minutes	Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.

Secondary Outcome Measures

Name	Time	Method
insertion time	10 minutes	IUD insertion time from speculum in to speculum out
the difference in the pain intensity scores between the study groups	5 minutes	the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain

Trial Locations

Locations (1)

Faculty of Medicine Cairo University; 🇪🇬 Giza, Egypt