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

NCT04080336 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-06-30

No results posted yet for this study

Summary

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

Conditions

  • IUD Insertion Complication

Interventions

DRUG

Dinoprostone

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

DRUG

Misoprostol

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

DRUG

placebo

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED SAMY · Cairo University

  • Mohamed El Sharkawy · Cairo University

  • Mohamed El Mahy · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2019-12-20
Completion
2020-01-20

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080336 on ClinicalTrials.gov