Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2019-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

NCT04046302

IUD Insertion

COMPLETED PHASE4

Dinoprostone vs Misoprostol Before LNG-IUD Insertion

NCT04301349

IUD Insertion Pain

UNKNOWN PHASE3

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

NCT03686085

Intrauterine Device

COMPLETED PHASE3

Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery

NCT04045548

Intrauterine Device

COMPLETED PHASE4

Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

NCT04080349

IUD Pain

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IUD Insertion Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.

Group Type EXPERIMENTAL

Dinoprostone

Intervention Type DRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.

placebo

one tablet of placebo self-administered by the patient 12 hours before IUD insertion.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.

Intervention Type DRUG

placebo

one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion Criteria

* pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

22 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No