Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women - Full Text View

Purpose

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	Intervention
Pain	Drug: Misoprostol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

Provider perceived ease of insertion on a 100-point visual analogue scale. [ Time Frame: Immediately post IUD insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient perceived pain on a 100-point visual analogue scale. [ Time Frame: Prior to insertion, immediately after insertion, and prior to clinic discharge. ] [ Designated as safety issue: No ]
Ability to insert the IUD without the use of adjunctive measures including ultrasound guidance or cervical dilation. [ Time Frame: During IUD insertion and immediately after. ] [ Designated as safety issue: No ]
Time for IUD insertion procedure. [ Time Frame: Assessed immediately after IUD insertion. ] [ Designated as safety issue: No ]
Presence of medication side effects. [ Time Frame: Assessed prior to IUD insertion, prior to leaving clinic, and at 1 week follow-up. ] [ Designated as safety issue: No ]
Procedure complications. [ Time Frame: Assessed up to 1 month from time of IUD insertion. ] [ Designated as safety issue: Yes ]
Need for additional pain medications the week following the procedure. [ Time Frame: 1 week after IUD insertion. ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	February 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
Placebo Comparator: Placebo Pills which are identical to the study drug in appearance, taste, and smell.	Drug: Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.

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.

Eligibility

Ages Eligible for Study:	14 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307111

Contacts

Contact: Eve Espey, MD/MPH

505-272-3942

eespey@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico Center for Reproductive Health	Recruiting
Albuquerque, New Mexico, United States, 87112
Principal Investigator: Eve Espey, MD/MPH

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

No publications provided by University of New Mexico

Additional 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.

Responsible Party:	Eve Espey, Professor, OB-GYN, University of New Mexico
ClinicalTrials.gov Identifier:	NCT01307111 History of Changes
Other Study ID Numbers:	HRRC #09-426
Study First Received:	March 1, 2011
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of New Mexico:

Misoprostol
IUD insertion
Nulliparous Women

Contraception
Family Planning
IUD insertion in nulliparous women

Additional relevant MeSH terms:

Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 23, 2013