Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

NCT ID: NCT03686085

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2019-03-10

Brief Summary

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in nulliparous women.

Detailed Description

Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a first line of contraception in nulliparous women.

Conditions

Intrauterine Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

dinoprostone arm

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

Group Type: EXPERIMENTAL

Dinoprostone 3 mg

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

placebo vaginal tablet

Intervention Type: DRUG

1 vaginal tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Interventions

Dinoprostone 3 mg

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

Intervention Type: DRUG

placebo vaginal tablet

1 vaginal tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test.

Exclusion Criteria

• • a prior pregnancy greater than 20 weeks of duration

• currently pregnant or were pregnant within 6 weeks of study entry
• had a prior attempted or successful IUD insertion
• had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
• any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
• active vaginitis or cervicitis
• undiagnosed abnormal uterine bleeding
• pelvic inflammatory disease within the last 3 months
• fibroids or other uterine abnormalities distorting the uterine cavity
• contraindication to dinoprostone.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

lecturer in obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Medicine Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

vaginal dinoprostone nullipara

Identifier Type: -

Identifier Source: org_study_id