Misoprostol Prior to IUD Insertion in Nullipara

Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Family Planning
• Intervention / Treatment: Drug: Vaginal misoprostol

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 Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070450
      • Instituto de Medicina Integral Professor Fernando Figueira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vaginal Misoprostol Group; Vaginal misoprostol (400 μg) 4 hours prior to IUD insertion	Drug: Vaginal misoprostol; To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women; Other Names: Prostokos
Placebo Comparator: Placebo group; Vaginal placebo tablets 4 hours prior to IUD insertion	Drug: Vaginal misoprostol; To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women; Other Names: Prostokos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty in inserting IUD	subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy	four hours after misoprostol use
Pain at insertion	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.	four hours after misoprostol use

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective sensation as reported by the woman	the woman's subjective evaluation of the procedure (IUD insertion)was classified as not disagreeable, slightly disagreeable, disagreeable or very disagreeable.	four hours after misoprostol use

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Contraception; Misoprostol; Intrauterine device; Nulliparous women
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: MISO DIU 01