Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Overweight and Obese Women :a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04505917

Enrollment

200

Registered

2020-08-10

Start date

2020-09-01

Completion date

2021-08-30

Last updated

2020-08-18

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

Conditions

IUCD Complication

Brief summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese women

Detailed 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.

Interventions

DRUGdinoprostol

2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.

DRUGmisoprostol

2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

DRUGplacebo

2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind randomized controlled trial

Intervention model description

double blind randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* multi parous women requesting copper IUD insertion * body mass index more than 25

Exclusion criteria

* pregnancy, * null parous women, * contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, * untreated active cervicitis or vaginitis, * undiagnosed abnormal uterine bleeding

Design outcomes

Primary

Measure	Time frame	Description
The difference in visual analog scale pain scores during intrauterine device insertion	10 minuts	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary

Measure	Time frame	Description
Intensity of pain: visual analogue scale	30 minutes after the procedure	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
the difference in visual analog scale pain scores during tenaculum application	10 minutes	The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10
the ease of IUD insertion	10 minutes	the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)
women's satisfaction level: score	10 minutes	women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction

Countries

Egypt

Contacts

Primary Contacthany f Sallam, md

hany.farouk@aswu.edu.eg+20102435461

Backup Contactnahla w Shady, md

hanygyne@yahoo.com+201022336052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026