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

NCT03686085 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-06-30

No results posted yet for this study

Summary

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

Conditions

  • Intrauterine Device

Interventions

DRUG

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.

DRUG

placebo vaginal tablet

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED SAMY, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-03-01
Completion
2019-03-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03686085 on ClinicalTrials.gov