Misoprostol Prior to IUD Insertion in Nullipara

Study Overview
=================
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.

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

Conditions
-----------------
Family Planning

Intervention / Treatment
-----------------
* Drug: Vaginal misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
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)
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nulliparous women, Intrauterine device, Misoprostol, Contraception