Misoprostol Prior to IUD Insertion in Nullipara

NCT03490617 | Completed Phase 3

• 1 other identifier: MISO DIU 01
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.

Conditions

Family Planning

Keywords

Intrauterine device; Misoprostol; Nulliparous women; Contraception

Outcome Measures

Primary Outcomes (1)

• Cervical dilatation

  the frequency of women with cervical dilation ≤ 4 mm (measured by inserting a #4 Hegar dilator through the internal orifice of the cervix uteri immediately prior to IUD insertion

  four hours after misoprostol use

Secondary Outcomes (2)

• Difficulty in inserting IUD

  four hours after misoprostol use

• Pain at insertion

  four hours after misoprostol use

Other Outcomes (1)

• Subjective sensation as reported by the woman

  four hours after misoprostol use

Study Arms (2)

Vaginal Misoprostol Group

ACTIVE COMPARATOR

Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion

Drug: Vaginal misoprostol

Placebo group

PLACEBO COMPARATOR

Vaginal placebo tablets 4 hours prior to IUD insertion

Drug: Vaginal misoprostol

Interventions

Vaginal misoprostol DRUG

To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women

Also known as: Prostokos

Placebo group; Vaginal Misoprostol Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women
• No chirurgical procedure in the cervix
• Wish to use IUD as a contraceptive method

You may not qualify if:

• Presence of active cervical infection visible upon speculum exam (purulent cervicits)
• Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
• Pregnancy ending less than 6 weeks prior to enrollment in study
• History of prior IUD placement
• History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
• History of uterine surgery
• Allergy or intolerance to misoprostol or other prostaglandin
• Undiagnosed abnormal vaginal bleeding
• Malignancy of the genital tract
• Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
• Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070450, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: April 6, 2018
• Study Start: July 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 6, 2018

Record last verified: 2018-03

Locations

BR (1)