Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion
Condition: Intra-uterine Device Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      investigators aim through this study to evaluate and compare the Safety and efficacy of
      different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix
      beside the rate of occurrence of adverse effects.
    

Detailed description: 
      Today there is an ever-increasing variety of effective contraceptive methods. Although all
      have side effects, they offer a lower risk than that conferred by pregnancy Contraceptive
      methods are classified according to their effectiveness. The top tier offer the highest level
      of effectiveness (defined as <two pregnancies per 100 women per year) and fulfill the
      criteria of ease of use, long duration of action, minimal need for return visits to the
      clinic and minimal user motivation or intervention. These methods include intrauterine
      contraception, sub dermal contraceptive implants and male and female sterilization The
      American Congress of Obstetricians and Gynecologists encourages all women, especially
      adolescents, to use long-acting reversible contraception.

      Although intrauterine devices (IUDs) are safe, reliable and highly effective forms of long-
      acting reversible contraception and has a very low failure rate (0.2-0.6 per 100 women per
      year) , it is used by only 7.6% and 14.5% of contraceptive users in developed and developing
      countries, respectively

      According to the latest practice recommendations for contraceptive use by the Centers for
      Disease Control and Prevention, the potential barriers to IUD use include anticipated
      insertion pain and health care providers' concerns about difficult insertion ( It is
      therefore important to identify effective approaches to ease IUD insertion in order to
      overcome obstacles hindering IUD use

      Insertion-associated pain is related to speculum insertion, tenaculum traction on the cervix,
      sounding of the uterus, passing of the insertion tube through the cervix and placement of the
      device within the uterine cavity

      Failure of insertion occurs in up to 14% and 20% of parous and nulliparous women,
      respectively 13).

      It has been suggested that difficulty and failure of insertion are experienced more in
      nulliparous women (adjusted odds ratio [AOR] 5.19; 95% confidence interval [CI] 2.49, 10.82)
      and in those with previous Caesarean delivery (AOR 5.38; 95% CI 2.58, 11.22), due to a
      narrower cervical os Fouda et al. found that women who had delivered only by Caesarean
      section experienced more pain with IUD insertion compared with women with previous vaginal
      delivery

      Many investigators have studied how to minimize insertion pain or failure. Few studies,
      however, have assessed any measure to decrease pain or difficulty during IUD insertion in
      women with previous Caesarean delivery (and no prior vaginal delivery) Pergialiotis et al.
      conducted a meta-analysis of clinical trials of analgesic options for IUD placement. Owing to
      the small number of trials, however, they concluded that further studies were needed before a
      conclusion could be reached

      Misoprostol is a synthetic analog of prostaglandin E1 originally approved for treatment and
      prevention of gastric ulcers induced by non steroidal anti inflammatory drugs. It can be
      administered sublingually, orally, vaginally, or rectally. Vaginal administration has been
      associated with the highest peak serum levels of misoprostol, and overall bioavailability is
      greatest for sublingual and vaginal administration.

      Misoprostol has well-known cervical ripening and uterotonic effects, naturally leading to its
      use as an adjunct in many gynecologic procedures. Its use has been well studied in the
      hysteroscopy literature. Multiple well-designed studies have validated the efficacy of
      different doses of misoprostol before hysteroscopy in reducing pain with dilation, reducing
      the number of failed dilations, and increasing cervical canal diameter before dilation Given
      these data, it is reasonable to hypothesize that pretreatment with misoprostol could aid in
      IUD insertion.

      As existing studies examining this question have asserted varied conclusions, through this
      study investigators will evaluate and compare the safety and efficacy of different doses of
      misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of
      occurrence of adverse effects.

      This study aims to compare the efficacy and safety of different doses of vaginal misoprostol
      prior to IUCD insertion among women with nulliparous cervix "those who never delivered
      vaginally".
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix.
Other intervention name(s): misotac
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: misoprostol; IUCD