The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception; Pain
Intervention: Insertion of nitroglycerin ointment (Drug); Insertion of placebo ointment (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Oregon Health and Science University
Summary
Increasing ease of access of long-acting birth control methods, like intrauterine devices
(IUDs), is an important way to reduce the risk of unintended pregnancy. Unfortunately, fear
of IUD insertion in women who have not had children is common among health care providers
and women alike, and this limits IUD use. To increase acceptance of this highly effective
birth control method, there is a need to explore new, low cost, and easily applied methods
to improve the insertion experience. This is a pilot study to evaluate the effectiveness and
acceptability of nitroglycerin ointment applied vaginally to improve the IUD insertion
experience for both patient and provider. The investigators hypothesis is that nitroglycerin
ointment will decrease the pain associated with IUD insertion.
Clinical Details
Official title: The Effect of Nitroglycerin on the IUD Insertion Experience in Nulliparous Women: a Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Patient-reported pain at passage of insertion device through cervix, as measured on a 100 mm VAS
Secondary outcome: Provider ease with insertion measured on a 100 mm VASPatient-reported pain at tenaculum placement, as measured on a 100 mm VAS Vital signs after insertion of nitroglycerin ointment Side effects after insertion of nitroglycerin ointment
Detailed description:
Increasing acceptability and use of long acting reversible contraceptive methods like the
intrauterine device (IUD) is an important strategy to reduce the risk of unintended
pregnancy. Unfortunately, fear of IUD insertion in nulliparous women is common among health
care providers and women alike, and this limits IUD use. While many health care providers
assume that placement is more difficult in nulliparous women, there is no evidence that the
risk of unsuccessful insertion is higher. Women worry about pain with insertion, and their
fear is not unfounded as U. S. and international data have shown that nulliparous women
report approximately twice as much pain with IUD insertion compared to parous women.
A key difference between nulliparous and multiparous women is the resistance of the cervix.
While cervical dilation is uncommonly needed during IUD placement, force is often required
to pass the insertion device through the internal os. Although misoprostol and ibuprofen
have been studied as ways to improve the IUD insertion experience, neither has proved
effective, and misoprostol actually has been shown to increase pain. Therefore, to increase
acceptance of this highly effective contraceptive, there is a need to investigate novel, low
cost, easily applied and accessible techniques to improve the insertion experience.
Nitric oxide (NO) donors, including nitroglycerin, nitroprusside, isosorbide mononitrate and
isosorbide dinitrate, have effects on the animal and human cervix. Both nitroglycerin and
isosorbide mononitrate tablets administered vaginally have been shown in RCTs to induce
effective cervical ripening with minimal side effects for first trimester abortion compared
to placebo. Nitroprusside and isosorbide dinitrate gel given intracervically prior to first
trimester abortion also have showed minimal side effects in several RCTs, but with mixed
results regarding effectiveness. Additional safety data about NO donors applied topically
to skin and mucosal surfaces is well established through the routine use of topical
nitroglycerin for treatment of anal fissures.
Although a recent randomized controlled trial (RCT) comparing nitroprusside gel to
misoprostol for cervical ripening prior to first trimester surgical abortion found superior
cervical dilation in the misoprostol group, there was no significant difference in cervical
dilation up to 5 mm. While most studies of abortion are concerned with providing adequate
dilation beyond 8 mm, the cervical remodeling that is necessary to help with IUD insertion
is much less, as the levonorgestrel intrauterine system (LNG-IUS) inserter is only 4. 75 mm
in diameter. Since NO donors are smooth muscle relaxants, they are expected to induce
cervical ripening without causing uterine cramping, which is the most significant side
effect of misoprostol.
Nitroglycerin is inexpensive, stable at room temperature, and readily available in tablet
and ointment form, as well as in a dextrose solution for intravenous administration. The
ointment form is commonly applied topically for the treatment of anal fissures. We propose
the following aims:
1. To determine if nitroglycerin ointment applied vaginally 30-45 minutes prior to IUD
insertion improves pain among nulliparous women compared to a placebo ointment.
Self-reported pain scores on a 100 mm VAS will be assessed at multiple time points
during and after the IUD insertion procedure. In addition, overall satisfaction and
adverse effects will be evaluated.
2. To determine if nitroglycerin ointment applied vaginally 30-45 minutes prior to IUD
insertion improves ease of IUD insertion for the provider compared to a placebo
ointment. In addition, need for additional dilation, additional pain medicine such as
paracervical block, inability to place the IUD, and complications will be tracked.
3. To determine if nitroglycerin ointment applied vaginally 30-45 minutes prior to IUD
insertion is safe and well tolerated. Side effects related to treatment with
nitroglycerin ointment or placebo will be compared. Blood pressure will be measured at
multiple time points.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. age 18-45 years,
2. generally healthy,
3. requesting a LNG-IUS for contraception as the primary indication
Exclusion Criteria:
1. Previous pregnancy beyond 20 weeks;
2. previous IUD placement or attempted IUD placement;
3. previous cervical cold knife cone (CKC) or loop electrosurgical excision procedure
(LEEP);
4. contraindication to LNG-IUS (including pregnancy, fibroids that distort the uterine
cavity, exam consistent with PID, allergy to any component of the LNG-IUS, etc);
5. concurrent use of any form of nitrate therapy or medications that interact with
nitroglycerin (such as phosphodiesterase V inhibitors);
6. known allergy to nitroglycerine or common topical ointment ingredients;
7. known renal or hepatic impairment;
8. history of hypertensive or hypotensive disorder;
9. history of migraine, cluster headaches, or vascular headaches;
10. history of myocardial infarction;
11. uncontrolled congestive heart failure;
12. unstable angina;
13. tobacco or alcohol amblyopia;
14. congenital optic atrophy;
15. blood pressure less than 90/55 or greater than 150/100 in office prior to speculum
exam
Locations and Contacts
Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting Elizabeth Micks, MD, Phone: 503-494-9556 Elizabeth Micks, MD, Principal Investigator Paula Bednarek, MD, MPH, Principal Investigator
Planned Parenthood Columbia Willamette, Portland, Oregon 97212, United States; Not yet recruiting Brenna Monahan, Email: brenna.monahan@ppcw.org
Additional Information
Starting date: December 2011
Last updated: February 4, 2013
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