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Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement

Pain Control for Intrauterine Device Placement: A Randomized, Double Blind Control Trial of Ketorolac Prior to Intrauterine Device Placement.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01664559
Enrollment
67
Registered
2012-08-14
Start date
2012-07-31
Completion date
2014-03-31
Last updated
2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Control With IUD Insertion

Keywords

intrauterine device, ketorolac, toradol, mirena, paragard, pain control

Brief summary

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.

Detailed description

Modern intrauterine devices are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy (Zieman 2010). Fear of intrauterine device placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block compared to paracervical block alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement (Massey 1974). Studies to evaluate effectiveness of motrin and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous (Jensen 1998, Hubacher 2006, Saav 1997). There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed (Oloto 1996). There have been no studies published to date regarding the use of ketorolac for decreasing pain during and after IUD placement. Ketorolac is an acetic acid NSAID that reversibly inhibits COX 1 and 2, leading to decreased formation of prostaglandin precursors, and is indicated for the use of moderate acute pain in the short term setting. Its administration in the office setting may be good option for providers since intramuscular administration leads to analgesia beginning at 30 minutes, maximal effect 1 to 2 hours after administration, and duration of analgesia approximately 4 to 6 hours for the 30mg intramuscular injection. Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers at UCSD often suggest certain options. These include ibuprofen at least one hour prior to the procedure, or ibuprofen taken within a few hours after the procedure, or ketorolac injection at least 15-30 minutes prior to the procedure. It would be beneficial for providers to have an evidence based option for patients.

Interventions

DRUGKetorolac

Ketorolac 30mg intramuscular injection, 1cc volume

DRUGNormal Saline

Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection

Sponsors

Lynn Ngo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

Exclusion criteria

* Pregnancy * Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis) * If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs * Misoprostol administration within 24 hours of enrollment * History of prior IUD insertion * Known allergy to NSAIDs including diagnosis of aspirin or NSAID induced asthma or urticaria * Known contraindications to NSAIDs, such as the following medications that are risk category D (consider therapy modification) or X (avoid combination) including * bile acid sequestrants (D - may decrease absorption of NSAIDs) * cyclosporine (D - NSAIDs may enhance the nephrotoxic effects) * drotrecogin alfa (D - NSAIDs may enhance the adverse/toxic effects, cause bleeding) * floctafenine (X - may enhance adverse/toxic effect of NSAIDs) * lithium (D - NSAIDs may decrease serum concentration) * methotrexate (D - NSAIDs may decrease excretion) * pentoxifylline (X - Ketorolac may enhance adverse/toxic effects) * probenecid (X - may increase serum concentration of Ketorolac) * rivaroxaban (D - Anti-platelet drugs may enhance anti-coagulation effect) * SSRIs (D - may enhance the anti-platelet effect of NSAIDs, NSAIDs may diminish the therapeutic effect of SSRIs) * warfarin (D - NSAIDs may enhance the anti-coagulation effect) * Renal insufficiency (by history and/or chart review) * Peptic ulcer disease or history of significant gastrointestinal bleeding * Known thrombocytopenia, known coagulopathy, or known bleeding disorder * Known contraindications to IUD

Design outcomes

Primary

MeasureTime frameDescription
VAS (Visual Analogue Scale) Measurement of PainPain with IUD placement, measured immediately after placementThe patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.

Secondary

MeasureTime frameDescription
Pain Scores at Other Time Points During and After IUD Placementimmediately after each step (see description)The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever. 1. Prior to injection of study drug, anticipated pain 2. Pain from study drug injection, measured immediately after injection 3. Pain from speculum insertion, measured immediately after insertion 4. Pain with tenaculum placement, measured immediately after placement 5. Pain with uterine sounding, measured immediately after removal of the sound 6. Pain at 5 minutes after placement of the intrauterine device 7. Pain at 15 minutes after placement of the intrauterine device
Nulliparous Patients - Subgroup Analysisimmediately after each step (see description)The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever. 1. Prior to injection of study drug, anticipated pain 2. Pain from study drug injection, measured immediately after injection 3. Pain from speculum insertion, measured immediately after insertion 4. Pain with tenaculum placement, measured immediately after placement 5. Pain with uterine sounding, measured immediately after removal of the sound 6. Pain at 5 minutes after placement of the intrauterine device 7. Pain at 15 minutes after placement of the intrauterine device
Post-insertion Patient Questionnaireassessed at 15 minutes after IUD insertionQuestions assessed in multiple choice format: 1. Side effects 2. injection site pain 3. overall satisfaction with IUD insertion experience 4. would they still recommend IUD placement to a friend? 5. significant pain for which they desired acetaminophen prior to leaving the office?
Post-insertion Provider QuestionnaireImmediately after IUD placement, on average within 1 hourThe provider will be asked to fill out a multiple choice format questionnaire: 1. what level training are you? 2. which IUD was inserted? 3. what was the purpose of IUD placement? 4. what was the position of the uterus? 5. did the IUD placement process require cervical dilation? 6. were you able to complete the IUD insertion? 7. was there bleeding from the cervix that required more than 5 min to control? 8. were there any major complications with the IUD insertion? 9. did the patient take tylenol prior to leaving the office?

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo With 1cc Normal Saline IM
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route. Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
34
Toradol, 30mg in 1cc IM
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route. Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
33
Total67

Baseline characteristics

CharacteristicPlacebo With 1cc Normal Saline IMToradol, 30mg in 1cc IMTotal
Age, Continuous27.3 years
STANDARD_DEVIATION 5.4
26.6 years
STANDARD_DEVIATION 5.1
26.9 years
STANDARD_DEVIATION 5.3
Body mass index27.6 kg/m2
STANDARD_DEVIATION 5.7
27.3 kg/m2
STANDARD_DEVIATION 5.8
27.4 kg/m2
STANDARD_DEVIATION 5.7
Currently breastfeeding15 participants15 participants30 participants
Gravidity1 pregnancies1 pregnancies1 pregnancies
History of loop electrosurgical excision procedure0 participants3 participants3 participants
Level of education
College degree
7 participants6 participants13 participants
Level of education
Graduate degree
7 participants11 participants18 participants
Level of education
High school graduate
7 participants4 participants11 participants
Level of education
Less than high school
0 participants1 participants1 participants
Level of education
Some college
12 participants11 participants23 participants
Parity1 pregnancies1 pregnancies1 pregnancies
Race/Ethnicity, Customized
African American
14 participants12 participants26 participants
Race/Ethnicity, Customized
Asian or Pacific Islander
1 participants4 participants5 participants
Race/Ethnicity, Customized
Caucasian
13 participants12 participants25 participants
Race/Ethnicity, Customized
Hispanic
4 participants2 participants6 participants
Race/Ethnicity, Customized
Other
2 participants3 participants5 participants
Sex/Gender, Customized34 female participants33 female participants67 female participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 340 / 33
serious
Total, serious adverse events
0 / 340 / 33

Outcome results

Primary

VAS (Visual Analogue Scale) Measurement of Pain

The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.

Time frame: Pain with IUD placement, measured immediately after placement

ArmMeasureValue (MEDIAN)
Placebo With 1cc Normal Saline IMVAS (Visual Analogue Scale) Measurement of Pain5.2 units on a scale
Toradol, 30mg in 1cc IMVAS (Visual Analogue Scale) Measurement of Pain3.6 units on a scale
p-value: 0.99Wilcoxon (Mann-Whitney)
Secondary

Nulliparous Patients - Subgroup Analysis

The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever. 1. Prior to injection of study drug, anticipated pain 2. Pain from study drug injection, measured immediately after injection 3. Pain from speculum insertion, measured immediately after insertion 4. Pain with tenaculum placement, measured immediately after placement 5. Pain with uterine sounding, measured immediately after removal of the sound 6. Pain at 5 minutes after placement of the intrauterine device 7. Pain at 15 minutes after placement of the intrauterine device

Time frame: immediately after each step (see description)

ArmMeasureGroupValue (MEDIAN)
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis8) 15 min after placement4.8 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis6) Pain with IUD placement8.1 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis2) Pain with injection1.8 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis3) Speculum insertion2.3 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis4) Tenaculum placement6.3 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis5) Uterine sounding8.4 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis7) 5 min after placement3.7 cm
Placebo With 1cc Normal Saline IMNulliparous Patients - Subgroup Analysis1) Anticipated pain2.8 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis6) Pain with IUD placement5.4 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis3) Speculum insertion1.5 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis4) Tenaculum placement4.3 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis5) Uterine sounding6.0 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis2) Pain with injection1.2 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis7) 5 min after placement2.7 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis8) 15 min after placement1.8 cm
Toradol, 30mg in 1cc IMNulliparous Patients - Subgroup Analysis1) Anticipated pain3.6 cm
Comparison: 1\) anticipated painp-value: 0.6Wilcoxon (Mann-Whitney)
Comparison: 2\) pain with injectionp-value: 1Wilcoxon (Mann-Whitney)
Comparison: 3\) speculum insertionp-value: 0.34Wilcoxon (Mann-Whitney)
Comparison: 4\) tenaculum placementp-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: 5\) uterine soundingp-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: 6\) IUD placementp-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: 7\) 5 min after placementp-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: 8\) 15 min after placementp-value: 0.02Wilcoxon (Mann-Whitney)
Secondary

Pain Scores at Other Time Points During and After IUD Placement

The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever. 1. Prior to injection of study drug, anticipated pain 2. Pain from study drug injection, measured immediately after injection 3. Pain from speculum insertion, measured immediately after insertion 4. Pain with tenaculum placement, measured immediately after placement 5. Pain with uterine sounding, measured immediately after removal of the sound 6. Pain at 5 minutes after placement of the intrauterine device 7. Pain at 15 minutes after placement of the intrauterine device

Time frame: immediately after each step (see description)

ArmMeasureGroupValue (MEDIAN)
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD PlacementSpeculum insertion2.6 cm
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD PlacementTenaculum placement3.9 cm
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD PlacementAnticipated pain4.4 cm
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD PlacementPain with injection1.0 cm
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD PlacementUterine sounding5.0 cm
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD Placement5 min after procedure2.2 cm
Placebo With 1cc Normal Saline IMPain Scores at Other Time Points During and After IUD Placement15 min after procedure1.6 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD Placement15 min after procedure0.1 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD PlacementSpeculum insertion1.5 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD PlacementPain with injection0.6 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD PlacementTenaculum placement2.5 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD PlacementUterine sounding4.3 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD Placement5 min after procedure0.3 cm
Toradol, 30mg in 1cc IMPain Scores at Other Time Points During and After IUD PlacementAnticipated pain3.5 cm
Comparison: 1\) Anticipated painp-value: 0.31Wilcoxon (Mann-Whitney)
Comparison: 2\) pain with injectionp-value: 0.33Wilcoxon (Mann-Whitney)
Comparison: 3\) speculum insertionp-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: 4\) tenaculum placementp-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: 5\) uterine soundingp-value: 0.64Wilcoxon (Mann-Whitney)
Comparison: 6\) 5 min after placementp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: 7\) 15 min after placementp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary

Post-insertion Patient Questionnaire

Questions assessed in multiple choice format: 1. Side effects 2. injection site pain 3. overall satisfaction with IUD insertion experience 4. would they still recommend IUD placement to a friend? 5. significant pain for which they desired acetaminophen prior to leaving the office?

Time frame: assessed at 15 minutes after IUD insertion

ArmMeasureGroupValue (NUMBER)
Placebo With 1cc Normal Saline IMPost-insertion Patient QuestionnaireInjection site pain - just as bad/worse than IUD8 participants
Placebo With 1cc Normal Saline IMPost-insertion Patient QuestionnaireDesires additional pain medication16 participants
Placebo With 1cc Normal Saline IMPost-insertion Patient QuestionnaireSatisfied or very satisfied with overall IUD proc30 participants
Placebo With 1cc Normal Saline IMPost-insertion Patient QuestionnaireRecommend IUD to a friend28 participants
Placebo With 1cc Normal Saline IMPost-insertion Patient QuestionnaireReported side effects12 participants
Toradol, 30mg in 1cc IMPost-insertion Patient QuestionnaireRecommend IUD to a friend30 participants
Toradol, 30mg in 1cc IMPost-insertion Patient QuestionnaireReported side effects8 participants
Toradol, 30mg in 1cc IMPost-insertion Patient QuestionnaireInjection site pain - just as bad/worse than IUD6 participants
Toradol, 30mg in 1cc IMPost-insertion Patient QuestionnaireSatisfied or very satisfied with overall IUD proc31 participants
Toradol, 30mg in 1cc IMPost-insertion Patient QuestionnaireDesires additional pain medication6 participants
Comparison: Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)p-value: >0.05Chi-squared
Comparison: Injection site pain (just as bad or worse than IUD procedure)p-value: 0.76Chi-squared
Comparison: Satisfied or very satisfied with IUD placement procedurep-value: 0.76Chi-squared
Comparison: Would recommend IUD placement to a friendp-value: 0.35Chi-squared
Comparison: Desires additional pain medicationp-value: 0.02Chi-squared
Secondary

Post-insertion Provider Questionnaire

The provider will be asked to fill out a multiple choice format questionnaire: 1. what level training are you? 2. which IUD was inserted? 3. what was the purpose of IUD placement? 4. what was the position of the uterus? 5. did the IUD placement process require cervical dilation? 6. were you able to complete the IUD insertion? 7. was there bleeding from the cervix that required more than 5 min to control? 8. were there any major complications with the IUD insertion? 9. did the patient take tylenol prior to leaving the office?

Time frame: Immediately after IUD placement, on average within 1 hour

ArmMeasureGroupValue (NUMBER)
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireCervical dilation needed2 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireLevel of training - Attending1 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireMajor complications0 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireIUD type - levonogestrel22 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnairePurpose of IUD - AUB1 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnairePosition of uterus - anteverted19 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnairePurpose of IUD - contraception33 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireLevel of training - PGY22 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnairePosition of uterus - retroverted6 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnairePosition of uterus - midpositioned9 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireLevel of training - PGY33 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireAble to complete the IUD placement34 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireIUD type - copper12 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireSignificant bleeding0 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireLevel of training - PGY45 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireTook acetaminophen prior to leaving the office17 participants
Placebo With 1cc Normal Saline IMPost-insertion Provider QuestionnaireLevel of training - PGY12 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireTook acetaminophen prior to leaving the office7 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireLevel of training - PGY15 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnairePosition of uterus - midpositioned8 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireMajor complications0 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireIUD type - copper2 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireLevel of training - PGY213 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireLevel of training - PGY36 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireLevel of training - PGY46 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireLevel of training - Attending3 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireIUD type - levonogestrel28 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnairePurpose of IUD - contraception32 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnairePurpose of IUD - AUB1 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnairePosition of uterus - anteverted20 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnairePosition of uterus - retroverted5 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireCervical dilation needed2 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireAble to complete the IUD placement33 participants
Toradol, 30mg in 1cc IMPost-insertion Provider QuestionnaireSignificant bleeding2 participants
Comparison: Level of training, PGY 1, 2, 3, 4 and Attendingp-value: 0.2Chi-squared
Comparison: IUD type (levonorgestrel or copper)p-value: 0.09Chi-squared
Comparison: Purpose of IUD (contraception or heavy menstrual bleeding)p-value: 1Chi-squared
Comparison: Position of uterus (anteverted, retroverted, midpositioned)p-value: 0.92Chi-squared
Comparison: Need for cervical dilationp-value: 1Chi-squared
Comparison: Able to complete the IUD insertionp-value: 1Chi-squared, Corrected
Comparison: Significant bleedingp-value: 0.24Chi-squared
Comparison: Major complicationsp-value: 1Chi-squared
Comparison: Took acetaminophen prior to leaving the officep-value: 0.02Chi-squared

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026