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COMPLETEDPhase 3NCT03686085

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.

Lead sponsor: Cairo University•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cairo University

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.

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 30, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment200

Start dateSep 2018

Last updatedJun 30, 2020

Condition

Intrauterine Device

Locations shown

Faculty of Medicine Cairo University

Giza

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 30, 2020Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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