Dinoprostone vs Misoprostol Before LNG-IUD Insertion

Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04301349

Enrollment

200

Registered

2020-03-10

Start date

2020-03-15

Completion date

2020-06-30

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 Pain

Brief summary

the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Interventions

DRUGvaginal dinoprostone

two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion

DRUGvaginal misoprostol

two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion

DRUGplacebo

two tablets of placebo given 3 hours prior to IUD insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* multiparous women requesting IUD insetion

Exclusion criteria

* active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

Design outcomes

Primary

Measure	Time frame	Description
pain during IUD insertion: visual analog scale	2 minutes	pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Secondary

Measure	Time frame	Description
duration of IUD insertion	5 minutes	duration of IUD insertion measured in minutes

Contacts

Primary ContactAHMED SAMY, MD

ahmedsamy8233@gmail.com+201100681167

Outcome results

None listed

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