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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04045548
Other study ID # dinoprostone IUD
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 10, 2019
Est. completion date January 5, 2020

Study information

Verified date January 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 5, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Non-pregnant women

- Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion

- Women who delivered only by cesarean section

Exclusion Criteria:

- Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.

- Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use

- Allergy to dinoprostone.

- Women refuse to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.
Placebo
one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Locations

Country Name City State
Egypt faculty of medicine Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in pain scores during intrauterine device insertion The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 10 minutes
See also
  Status Clinical Trial Phase
Completed NCT03686085 - Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women. Phase 3
Recruiting NCT05550064 - Structured Contraceptive Counseling During Pregnancy N/A
Recruiting NCT06179095 - The Effect of Virtual Reality on Anxiety During Intrauterine Device Insertion N/A
Completed NCT03383432 - Intrauterine Device Insertion: a Step for High Satisfaction N/A
Completed NCT03600064 - Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal N/A
Completed NCT05556421 - Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
Completed NCT03870711 - 10% Lidocaine Spray for Intrauterine Device Insertion Phase 4
Completed NCT02898831 - Cold Compress for Pain Associated With Intrauterine Device Insertion N/A