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OpenTrials
Completed

NCT Number: NCT03686085

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

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

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Key information

Conditions

Intrauterine Device

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Cairo University

Giza, 11231, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dinoprostone 3 mg

Drug

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

placebo vaginal tablet

Drug

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

Primary outcomes

  1. Provider ease of insertion

    Time frame: 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 outcomes

  1. the difference in the pain intensity scores between the study groups

    Time frame: 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

  2. insertion time

    Time frame: 10 minutes

    IUD insertion time from speculum in to speculum out

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2018
Registry last updated
Jun 30, 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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