NCT02841826

Brief Summary

The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years. The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia. The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

July 20, 2016

Last Update Submit

November 23, 2016

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • The degree of pain perception measured visual analogue score

    15 minutes

Study Arms (2)

Group I: IUD without uterine sound group

OTHER

Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.

Other: IUDRadiation: Transvaginal ultrasound

Group II: IUD with uterine sound

OTHER

Intrauterine contraceptive device inserted by classic method

Other: IUDOther: Uterine sounding

Interventions

IUDOTHER
Group I: IUD without uterine sound groupGroup II: IUD with uterine sound
Uterine soundingOTHER
Group II: IUD with uterine sound
Transvaginal ultrasoundRADIATION
Group I: IUD without uterine sound group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women requesting intrauterine contraceptive device as a contraction
  • Women accepted participation in the study

You may not qualify if:

  • Uterine abnormalities
  • Endometrial lesions as polyp
  • Adenomyosis
  • Fibroids distorting the cavity
  • Intrauterine adhesions.
  • Chronic pelvic pain
  • Dysmenorrhea
  • History of cervical surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 22, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

EG(1)