Trial Outcomes & Findings for Postplacental Intrauterine Device Insertion: A Mixed Methods Assessment of Women's Experience (NCT NCT02312726)

Last Updated: 2016-04-04

Results Overview

A semi-structured interview guide(available in both English and Spanish) which was developed in consultation with an expert in qualitative methodology at the UNM Clinical \& Translational Science Center (CTSC), and UNMH family planning experts, will be administered to all participants. The interview will incorporate the following domains of women's perceptions of the postplacental IUD insertion experience: decisional influence, experience during the procedure, decisional regret, prior knowledge/ awareness of the method and postpartum contraception in general. The interview will conclude with an overall patient satisfaction score measured on a five-point Likert scale: 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, 5 = very satisfied.

Recruitment status

COMPLETED

Target enrollment

135 participants

Primary outcome timeframe

Within 24-48 hours after vaginal delivery, prior to hospital discharge

Results posted on

2016-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Epidural Group Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.	Non Epidural Group Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.	Excluded Participants who did not meet inclusion criteria or declined after consent.
Overall Study STARTED	38	30	67
Overall Study COMPLETED	38	30	0
Overall Study NOT COMPLETED	0	0	67

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postplacental Intrauterine Device Insertion: A Mixed Methods Assessment of Women's Experience

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Participants Enrolled in Study n=68 Participants Participant characteristics for those enrolled in the study, in both the epidural and non-epidural group
Age, Customized Median Age	27 years n=5 Participants
Sex/Gender, Customized Female	68 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	61 participants n=5 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan	4 participants n=5 Participants
Race/Ethnicity, Customized Asian American	1 participants n=5 Participants
Race/Ethnicity, Customized White	1 participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants
Education Did not complete high school	21 participants n=5 Participants
Education Completed high school/ GED	28 participants n=5 Participants
Education In college/completed some college	16 participants n=5 Participants
Education Completed college	3 participants n=5 Participants
Employment Employed part time	8 participants n=5 Participants
Employment Employed full time	8 participants n=5 Participants
Employment Student	7 participants n=5 Participants
Employment Homemaker	31 participants n=5 Participants
Employment Temporary work leave	2 participants n=5 Participants
Employment Unemployed	12 participants n=5 Participants
Income Less than $20,000	39 participants n=5 Participants
Income $20,000 - $40,000	23 participants n=5 Participants
Income $40,000 - $60,000	3 participants n=5 Participants
Income $60,000 - $80,000	1 participants n=5 Participants
Income Declined to answer	2 participants n=5 Participants
Language of Preference English	38 participants n=5 Participants
Language of Preference Spanish	30 participants n=5 Participants
Insurance None	39 participants n=5 Participants
Insurance Medicaid	26 participants n=5 Participants
Insurance Commercial	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 24-48 hours after vaginal delivery, prior to hospital discharge

Population: 21 participants (out of the 68 included in the study) consented to an interview regarding their experience. We conducted 21 interviews; 9 with women who did not have an epidural and 12 with women who had an epidural.

Outcome measures

Outcome measures
Measure	Epidural Group n=12 Participants Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion. Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.	Non Epidural Group n=9 Participants Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.
Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews Very Satified	12 participants	7 participants
Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews Satisfied	0 participants	2 participants
Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews Neutral	0 participants	0 participants
Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews Dissatisfied	0 participants	0 participants
Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews Very Dissatisfied	0 participants	0 participants

SECONDARY outcome

Timeframe: Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery; women who undergo a postpartum interview will be asked to perform a recall VAS pain assessment

This is a validated instrument used extensively in the assessment of acute pain. When prompted, patients will be asked to mark the continuous 100 mm VAS line at the point which most accurately represents their pain level; 0 = no pain, 100 = pain as bad as it could be.

Outcome measures

Outcome measures
Measure	Epidural Group n=38 Participants Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion. Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.	Non Epidural Group n=30 Participants Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.
Pain Score: Visual Analog Scale (VAS) Pre-insertion	10.6 units on a scale Standard Deviation 15.9	35.3 units on a scale Standard Deviation 29.3
Pain Score: Visual Analog Scale (VAS) Procedure	10.9 units on a scale Standard Deviation 19.5	41.4 units on a scale Standard Deviation 34.1
Pain Score: Visual Analog Scale (VAS) Recall	5.4 units on a scale Standard Deviation 7.4	28.6 units on a scale Standard Deviation 33.2

SECONDARY outcome

Timeframe: Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery. Women who undergo a postpartum interview will be asked to perform a recal VRS pain assessment

This is a 4-item ordinal pain scale which has been used for pain level assessment. When prompted, patients will be asked to indicate which level of pain most accurately represents their pain level; 0 = No pain, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain.

Outcome measures

Outcome measures
Measure	Epidural Group n=38 Participants Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion. Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.	Non Epidural Group n=30 Participants Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.
Pain Score: Verbal Rating Scale (VRS) No Pain or Mild Pain during IUD placement	32 participants	16 participants
Pain Score: Verbal Rating Scale (VRS) Moderate Pain or Severe Pain before IUD placement	2 participants	15 participants
Pain Score: Verbal Rating Scale (VRS) No Pain or Mild Pain before IUD placement	34 participants	15 participants
Pain Score: Verbal Rating Scale (VRS) No Pain or Mild Pain at recall	12 participants	6 participants
Pain Score: Verbal Rating Scale (VRS) Moderate Pain or Severe Pain during IUD placement	4 participants	14 participants
Pain Score: Verbal Rating Scale (VRS) Moderate Pain or Severe Pain at recall	0 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 5 minutes following postpartum IUD insertion

The provider who inserts the IUD will be asked to complete a 4-item Likert scale rating perceived difficultly of insertion: 1 = easy; 2 = somewhat easy; 3 = somewhat difficult, 4 = difficult.

Outcome measures

Outcome measures
Measure	Epidural Group n=38 Participants Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion. Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.	Non Epidural Group n=30 Participants Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.
Provider Ease-of-insertion Easy	19 participants	15 participants
Provider Ease-of-insertion Somewhat easy	16 participants	11 participants
Provider Ease-of-insertion Somewhat difficult	3 participants	3 participants
Provider Ease-of-insertion Difficult	0 participants	0 participants
Provider Ease-of-insertion Unanswered	0 participants	1 participants

Adverse Events

Epidural Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Epidural Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michel Paves, Research Specialist

University of New Mexico - Family Planning Research Division

Phone: 505-272-9703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place