Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Misoprostol Prior to IUD Insertion in Nullipara

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490617
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Melania Amorim, Instituto Materno Infantil Prof. Fernando Figueira

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.

Condition or disease Intervention/treatment Phase
Family Planning Drug: Vaginal misoprostol Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Misoprostol Prior To Cupper Intra Uternine Device Insertion In Nullipara: A Randomized Clinical Trial
Study Start Date : July 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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 Name: 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 Name: Prostokos




Primary Outcome Measures :
  1. Cervical dilatation [ Time Frame: four hours after misoprostol use ]
    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


Secondary Outcome Measures :
  1. Difficulty in inserting IUD [ Time Frame: four hours after misoprostol use ]
    subjective difficulty (as reported by the investigator) in inserting the IUD and classified as difficult, very difficult and easy

  2. Pain at insertion [ Time Frame: four hours after misoprostol use ]
    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.


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490617


Locations
Layout table for location information
Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil, 50070450
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira

Layout table for additonal information
Responsible Party: Melania Amorim, PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT03490617    
Other Study ID Numbers: MISO DIU 01
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018
Keywords provided by Melania Amorim, Instituto Materno Infantil Prof. Fernando Figueira:
Intrauterine device
Misoprostol
Nulliparous women
Contraception
Additional relevant MeSH terms:
Layout table for MeSH terms
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics