Misoprostol Prior to Intrauterine Contraceptive Device Insertion
Condition: Pain Prior to IUD Insertion
Study type: Interventional
Phase: Phase 1

Summary: 
      Intrauterine devices (IUDs) are widely used as reversible contraceptives. Both copper- and
      levonorgestrel (LNG)-releasing IUDs (LNG-IUDs) are safe,cost-effective in the long term and
      equally effective compared with tubal sterilization.

      In addition, the LNG-IUD (Mirena®) provides non contraceptive benefits, such as treatment for
      menorrhagia, dysmenorrhea and anemia. The current use of IUDs among reproductive-aged women
      ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8%
      insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and
      5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women
      who have never delivered vaginally.

      Cervical stenosis, an immature or small cervix and a significantly ante- or retroverted
      position of the uterus, has been described as factors associated with a difficult sounding of
      the cervical canal or even failure to insert the IUD.

      Misoprostol is an inexpensive prostaglandin E1-analogue, which is associated with few side
      effect. More over several have shown the benefit of misoprostol as a cervical ripening agent
      in non pregnant women. Priming with misoprostol prior to hysteroscopy and dilatation and
      curettage (D&C) in perimenopausal women resulted in increased cervical dilatation and lower
      rate of cervical laceration.

      The effect of misoprostol on the cellular matrix causes dissolution of collagen fiber
      increasing the amount of fluid in the stroma and consequentially causes cervical effacement.
      Fear of pain during insertion, however, might prevent some women from choosing IUD and fears
      of painful and/or difficult placements may lead them to recommend or counsel women on other,
      less effective methods.

      Women's perception of pain is multifactorial and likely to be influenced by cultural
      differences and personal experiences; insertion-related pain is therefore difficult to
      predict. Nevertheless, factors associated with greater pain include nulliparity, not
      currently breastfeeding and longer time since last pregnancy; of these factors, nulliparity
      is the strongest predictor of pain.

      The proportion of women of reproductive age who are nulliparous is increasing, with women
      delaying childbirth and having fewer children or choosing to remain childless. The proportion
      of Caesarean section births has also increased and women who have only ever had a Caesarean
      section are often viewed as nulliparous with respect to IUD placement. Anticipated pain is
      often greater than the actual pain experienced, and the majority of nulliparous women
      experience no more than moderate pain during IUD insertion. However, among nulliparous women
      there is a subset (about 17%) for whom the insertion of IUD is associated with severe
      pain.These women need effective pain relief.

      For most nulliparous, nulligravid or parous women, IUD insertion can be performed
      successfully without cervical priming and with a minimum amount of discomfort. Whether
      selective use of misoprostol has a role in management of pain in certain subsets of women
      (e.g. nulliparous women and those in whom the insertion is non-routine/difficult) has yet to
      be adequately studied.
    


Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 µg misoprostol vaginally 3 hours before IUD insertion.; This group will receive placebo
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vaginal misoprostol