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

Intrauterine Device Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686085
• Other study ID #: vaginal dinoprostone nullipara
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2018
• Est. completion date: March 10, 2019

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 10, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 in?ammatory disease within the last 3 months

• ?broids or other uterine abnormalities distorting the uterine cavity

• contraindication to dinoprostone.

Related Conditions & MeSH terms

• Intrauterine Device

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provider ease of insertion	Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.	5 minutes
Secondary	the difference in the pain intensity scores between the study groups	the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain	5 minutes
Secondary	insertion time	IUD insertion time from speculum in to speculum out	10 minutes