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Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

NCT04080349 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-09-06

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 insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.

Conditions

  • IUD Pain

Interventions

DRUG

Dinoprostone 3 mg

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

DRUG

Misoprostol 200Mcg Tab

1 vaginal tablet of misoprostol (200 mcg) (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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2019-11-30
Completion
2019-12-05

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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 NCT04080349 on ClinicalTrials.gov