Misoprostol Prior to IUD Insertion in Nullipara

Phase 3

Completed

• Conditions: Family Planning
• Interventions: Drug: Vaginal misoprostol

• Registration Number: NCT03490617
• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

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.

Detailed Description

Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2013-03-04
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-30
• Last Update Submitted: 2018-03-30
• Study First Posted: 2018-04-06
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 179

Inclusion Criteria

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

Exclusion criteria are as follows:

• 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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo group	Vaginal misoprostol	Vaginal placebo tablets 4 hours prior to IUD insertion
Vaginal Misoprostol Group	Vaginal misoprostol	Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion

Primary Outcome Measures

Name	Time	Method
Cervical dilatation	four hours after misoprostol use	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

Secondary Outcome Measures

Name	Time	Method
Difficulty in inserting IUD	four hours after misoprostol use	subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy
Pain at insertion	four hours after misoprostol use	judged subjectively by the woman and evaluated by the investigator using a visual analogue scale (VAS). The scale ranged from 0 to 10, in which zero is the absence of pain and 10 the worst pain imaginable.

Trial Locations

Locations (1)

Instituto de Medicina Integral Professor Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil