Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

• ClinicalTrials.gov Identifier: NCT01307111
• Recruitment Status: Completed
• First Posted: March 2, 2011
• Results First Posted: March 28, 2016
• Last Update Posted: March 28, 2016
• Sponsor: University of New Mexico
• Information provided by (Responsible Party): Eve Espey, University of New Mexico

Study Description

Brief Summary:

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Misoprostol; Drug: Placebo	Not Applicable

Detailed Description:

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women
• Study Start Date: February 2011
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Misoprostol; Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.	Drug: Misoprostol; 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
Placebo Comparator: Placebo; Pills which are identical to the study drug in appearance, taste, and smell.	Drug: Placebo; Pills which are identical to the study drug in appearance, taste, and smell.

Outcome Measures

Primary Outcome Measures :

1. Patient Perceived Pain on a 100-point Visual Analogue Scale. [ Time Frame: Prior to insertion, immediately after insertion, and prior to clinic discharge. ]
   Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.

Secondary Outcome Measures :

1. Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. [ Time Frame: Immediately post IUD insertion ]
   Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 14 years old or older
• Negative pregnancy test
• No prior pregnancies lasting beyond 19 6/7 weeks
• Minimum 2 weeks after spontaneous or medical abortion
• Minimum 4 weeks post 2nd trimester or surgical abortion
• No previous IUD insertions
• No PID in last 3 months
• No current cervicitis
• Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

• Active cervical infection
• Current pregnancy
• Prior pregnancy beyond 19 6/7 weeks gestation
• Known uterine anomaly
• Fibroid uterus distorting uterine cavity
• Copper allergy/Wilson's Disease (for Paragard)
• Undiagnosed abnormal uterine bleeding
• Cervical or uterine cancer

Contacts and Locations

Sponsors and Collaborators

University of New Mexico

Investigators

• Principal Investigator: Eve Espey, MD/MPH; University of New Mexico Department of Obstetrics and Gynecology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.

• Responsible Party: Eve Espey, Professor, OB-GYN, University of New Mexico
• ClinicalTrials.gov Identifier: NCT01307111
• Other Study ID Numbers: HRRC #09-426
• First Posted: March 2, 2011
• Results First Posted: March 28, 2016
• Last Update Posted: March 28, 2016
• Last Verified: February 2016

Keywords provided by Eve Espey, University of New Mexico:

Misoprostol; IUD insertion; Nulliparous Women; Contraception; Family Planning; IUD insertion in nulliparous women

Additional relevant MeSH terms:

Misoprostol; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Anti-Ulcer Agents; Gastrointestinal Agents; Oxytocics