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

Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04046302

Enrollment

160

Registered

2019-08-06

Start date

2019-08-30

Completion date

2020-01-30

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Insertion

Brief summary

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

Detailed description

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

Interventions

DRUGDinoprostone

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
the difference in the pain intensity scores between the study groups	5 minutes	the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026