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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-30

Study Completion Date

2020-01-30

Brief Summary

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

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Detailed Description

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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. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Conditions

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IUD Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dinoprostone

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

Group Type EXPERIMENTAL

Dinoprostone

Intervention Type DRUG

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

placebo

one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Interventions

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Dinoprostone

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

Intervention Type DRUG

placebo

one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.

Exclusion Criteria

* 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 or allergy to dinoprostone.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No