Misoprostol Prior to IUD Insertion in Nullipara

Family Planning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490617
• Other study ID #: MISO DIU 01
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2013
• Last updated: March 30, 2018
• Start date: July 2009
• Est. completion date: November 2011

Study information

• Verified date: March 2018
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Family Planning

Intervention

Drug:
• Vaginal misoprostol
To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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