Immediate Postplacental Intrauterine Device Insertion in High-risk Patient Populations
Phase: NA
Conditions: Contraception
Sponsor: Oregon Health and Science University

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
 
 
 
 
 
 
 
Official Title: 
Immediate Postplacental Intrauterine Device insertion in high-risk patients 
 
 
 
 
Principal Investigator: 
Jeffrey Jensen, MD, MPH 
 
 
Professor, Department of Obstetrics and Gynecology 
Oregon Health & Science University 
 
 
 
 
 
NCT No.  
NCT02169869 
 
 
 
 
Protocol Version Date:  
March 16, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
 
Protocol 
 
Title: Immediate Postplacental Intrauterine Device insertion in high-risk patients 
 
Keenan Yanit, MD 
 
Research Advisors: Jeffrey Jensen, MD, MPH; Alison Edelman, MD, MPH; Maureen 
Baldwin, MD, MPH 
 
1. Background 
 
Approximately half of all pregnancies in the United States are unintended.1 With 
the transition to new parenthood, women in the postpartum period are particularly 
susceptible to unintended pregnancy.  Recent data has shown that among women 18-24 
years of age, 57% had a repeat pregnancy within 18 months of delivery.2 
 
Intrauterine devices (IUD) provide safe, effective, and long acting reversible 
contraception (LARC).  For those who desire an IUD after delivery, common practice in 
the United States is insertion at 6 weeks postpartum. However, women who plan an IUD 
often face barriers to receiving one for many reasons including loss of insurance 
coverage, difficulty getting to postpartum visits, and early repeat pregnancy.3 Immediate 
postplacental IUD insertion is defined as IUD insertion within 10 minutes of the 
expulsion of the placenta.4 Although this practice is common in developing countries, it 
is rare in the United States.  There are several potential advantages to immediate IUD 
insertion including the cervix is already dilated, postplacental insertion is often performed 
under labor anesthesia therefore patients can avoid the potential discomfort related to 
IUD insertion, in addition, no additional visit is needed.  
Both the levonorgestrel and copper IUD provide contraception without interfering 
with breastfeeding.5 For women with limited access to medical care, hospitalization for 
delivery provides a unique opportunity to address the need for contraception. The major 
disadvantage to postplacental placement is an increase in expulsion rates; as high as 8-
24% by 6 months.6 One study suggests that the rate of expulsion has to do with the 
insertion technique and provider experience.6,7  Despite this higher expulsion rate, 
continuation rates for IUD use at 6 months appear to be equivalent for postplacental IUD 
as compared to routine 6 week insertion.6 In a setting where women typically attend a 
postpartum follow-up visit where IUDs are routinely available, postplacental placement 
has not been shown result in higher uptake of IUDs or to be cost-efficient.6   However, in 
a population at high risk for lack of postpartum follow-up, the higher expulsion risk 
becomes less a concern, as the alternative to postplacental placement would be nonuse of 
contraception or use of a less effective method.  Identification of a group of postpartum 
women at high risk for poor follow-up would enable targeted delivery of postplacental 
placement. Recent studies at our institution have shown women with a history of poor 
attendance to prenatal appointments are at high risk of not returning for routine 
postpartum IUD placement.8,9 Based on these recent studies, we hypothesize that women 
with less than 10 prenatal visits or 2 or more no show visits who receive an immediate 
postplacental IUD will have higher rates of IUD continuation at 3 months than women 
who are scheduled to receive an IUD at a delayed postpartum visit.   

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
 
2. Study Objective: To determine whether immediate postplacental IUD placement will 
improve IUD uptake at 3 month postpartum in women with a history of poor prenatal 
clinic attendance.  
 
3. Study Design:   
The study will be a randomized clinical trial. Women with less than 10 prenatal 
visits and/or 2 or more no show visits who desire an IUD will be considered for 
enrollment.  If consented and meet inclusion criteria, they will be randomized after 
delivery to receive an IUD immediately postplacental or at their routine postpartum visit.  
Women who plan to deliver a live birth singleton via vaginal or cesarean delivery 
at OHSU hospital will be considered for inclusion in the study. Women who desire an 
IUD for postpartum contraception will be approached for study participation. The 
postpartum contraception plan is routinely documented during their prenatal course.  It is 
also addressed by the obstetrical team upon admission to Labor & Delivery at OHSU.  
The obstetrical team will identify subjects who present in labor who meet the criteria of 
poor prenatal clinic attendance and express interest in intrauterine contraception.  These 
women will be provided with information about the study, and if interested will be 
provided with informed consent counseling.  Completion of the informed consent process 
and signing of the consent can be done before or after delivery depending on the 
individual circumstances of the labor.  Subjects that meet all inclusion and no exclusion 
criteria, and agree to the terms of the study, will be entered into the study after a 
discussion of study procedures and signing the informed consent.  Immediately after 
vaginal or cesarean delivery, consenting subjects will be randomized to immediate 
postplacental IUD placement or IUD placement at their routine postpartum visit. Women 
randomized to the immediate postplacental IUD group will receive their IUD within 60 
minutes of placental delivery. To minimize interference with the early postpartum 
interval, all subjects will be asked to complete a demographic questionnaire at their 
convenience at some point prior to hospital discharge.  Prior to discharge from the 
hospital women who received a postplacental IUD will be assisted in scheduling a routine 
postpartum visit with their primary provider. Subjects who are randomized for IUD 
insertion at their postpartum visit will be assisted in scheduling a postpartum visit and 
IUD placement with their usual obstetrical care provider.  All subjects in the delayed 
group will be provided with contact information for the Women’s Health Research Unit 
at OHSU.  If a subject cannot obtain an IUD at her usual place of care, the device will be 
placed at no cost through the WHRU. 
At 3 months after delivery, all subjects will be contacted by phone, text, or email 
to complete a questionnaire to determine whether they have had a known expulsion, 
pregnancy, or elective IUD removal. The questionnaire will include questions regarding 
ease of placement and overall satisfaction with the timing of placement. Subjects will be 
compensated for their participation in the study after the 3 month contact.  
 
 
4. Subject Recruitment: Participants will be recruited upon admission to OHSU Labor 
and Delivery. Researchers will pre-screen eligible subjects based on eligibility criteria 
through EPIC medical records and collect demographic information from women who 
elect to enroll in the study. Women who desire an IUD and have a history of poor 

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
prenatal clinic attendance with income <300% of the federal poverty line will be 
approached by residents. Subjects will be selected for the study according to the selection 
criteria detailed below.  
 
5. Consent: Whenever feasible the information about this research project will be made 
available to patients prior to labor.  Due to the nature of the study consent may be 
obtained during labor or in the immediate postpartum period. In order to ensure adequate 
consent is obtained in patients who present in labor, patients will be asked if it is an 
appropriate time to discuss a research study regarding timing of IUD placement.  If the 
time is not appropriate the investigator will wait until the circumstances have changed to 
re-visit the research study. Whenever possible research investigators will discuss the 
proposed research and obtain informed consent in the presence of one of the patient’s 
independent labor support persons. Patients will not be approached for participation in 
the study until at least 1 hour has passed after administration of systemic opioids or 
sedative medications. If feasible it may be preferable to delay approaching a patient until 
after epidural placement if such analgesia is desired by the patient as studies have shown 
that epidural analgesia does not alter mental status. Consent will always be obtained in 
the patient’s primary language.  
It is important to emphasize that consent prior to admission on labor and delivery 
is not possible, as we are seeking to enroll a group of women who have poor attendance 
at prenatal clinics.  While there are many reasonable concerns around obtaining consent 
in labor, the investigators in this study will be physicians who are experienced with the 
consent process for medical and surgical procedures (including the placement of IUDs 
immediate postplacental).  These physicians routinely obtain consent on the L&D unit, 
and understand the dynamics and unique challenges of laboring women.  We have built 
in additional flexibility to have potential subjects complete the informed consent process 
after delivery. 
 
6. Study Duration: The total duration for the study for each participant is expected to be 
approximately 3 months. 
 
7. Number of Subjects and Statistical Power: The study is expected to enroll 50 female 
subjects. With the proposed sample size of 20 subjects in each group, the study will have 
power of 81% to yield a statistically significant result. This computation assumes that a 
40% difference in the primary outcome of proportion of subjects using an IUD at 3 
months of follow-up (corresponding to proportions of  0.9 versus  0.5). This effect size is 
estimated assuming 90% IUD continuation rate in the immediate IUD group which takes 
into account the high expulsion rate, as compared to a 50% IUD continuation rate in the 
delayed IUD group which corresponds to the rate of return seen in this population as 
supported in two prior studies conducted at OHSU8,9. 
 
8. Selection of Subjects:  
a. Inclusion criteria:  
i. 
Female 
ii. 
18 yo or older 
iii. 
Singleton pregnancy at ≥32 weeks gestation at time of enrollment 

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
iv. 
Voluntarily requesting either copper T380A or levonorgestrel IUD placement 
for postpartum contraception 
v. 
English or Spanish speaking 
vi. 
Able to give consent and agree to the terms of the study 
vii. 
Less than 10 prenatal visits or 2 or more no show visits  
viii. 
Since IUDs are not on our hospital formulary, the patient must qualify for a 
LARC IUD (this includes all Oregon Health Plan (OHP) or Citizen/Alien 
Waived Emergent Medical (CAWEM) insured patients or women with 
income <300% of the federal poverty line). 
b. Exclusion Criteria:  
i. 
Anatomic uterine abnormalities that prevent proper fundal placement of IUD 
(obstructive myomata, bicornuate, septate, etc) 
ii. 
Chorioamnionitis (also consider other risk factors such as prolonged rupture of 
membranes >18 hours, prolonged labor >24 hours, fever >38C) 
iii. 
Puerperal sepsis 
iv. 
Unresolved postpartum hemorrhage 
v. 
Extensive genital trauma  
vi. 
Current incarceration 
vii. 
Known or suspected untreated endocervical gonorrhea, chlamydia 
viii. 
Wilson’s disease, copper allergy (Paragard only) 
ix. 
Known or suspected cervical or endometrial cancer or pelvic tuberculosis 
x. 
Current breast cancer (LNG-IUS only) 
xi. 
SLE with severe thrombocytopenia (Paragard only) 
xii. 
Trophoblastic disease (benign or malignant) 
xiii. 
AIDS not stable on antiretroviral  
 
9. Treatment Allocation: Randomization will be accomplished by opening the next in a 
series of numbered sealed opaque envelopes. The envelope will contain the subject 
randomization assignment. The envelope will be opened immediately after delivery. The 
randomization scheme will be by computer block randomization. 
 
10. Study Medications: All of the study medications are FDA-approved and they will be 
used according to the labeling indications. 
a. The levonorgestrel intrauterine system (Mirena IUS) is a radio-opaque T-shaped 
polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane 
on its stem.  The progestin is released at a rate of 15 mcg per day.  It is FDA approved for 
up to five years of use in the United States. 
b. The Copper T380A IUD (ParaGard) is a T-shaped polyethylene device with 380 
mm2 of exposed surface area of fine copper wire wound around its arms and stem.  Barium 
sulfate has been added to the polyethylene frame to make the device radio-opaque.  A 3-
mm plastic ball is located at the base of the IUD, through which the polyethylene 
monofilament string passes.  It is FDA approved for up to 10 years of use in the United 
States. 
 
 
 

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
11. Study Laboratory Tests and Procedures:  
a. Laboratory testing: No routine laboratory tests are indicated for the study.  For immediate 
postplacental placement, no testing is indicated.  For women randomized to IUD placement 
at their routine postpartum visit, clinicians will obtain urine pregnancy tests and or DNA 
probe for gonorrhea and chlamydia testing according to established clinic protocols.  Should 
the test result be positive, the subject will be contacted by her primary provider for treatment. 
b. Immediate postplacental IUD insertion technique: IUD insertion will be performed by an 
experienced study investigator (residents or faculty) who has received training in the 
technique. Pain management will be per clinical judgment and include pre-existing 
epidural/spinal, IV, or local anesthetic as necessary to ease comfort.  Two ring forceps, 
ovum forceps, speculum/vaginal retractor, 4x4sponges, antiseptic solution, and the IUD 
will be added to the delivery table. Ultrasound will be available at the bedside. The 
external genitalia will be cleansed and properly draped. A speculum or vaginal retractor 
will be placed to visualize the cervix. The cervix will be cleansed with antiseptic and 
grasped at the anterior cervical lip with the ring forceps. The Cu IUD will be grasped with 
the ring/ovum forceps and placed at the uterine fundus. The Mirena can be placed with the 
IUD inserter, or with the forceps according the providers discretion. Ultrasound will be 
used to ensure fundal placement. At the end of insertion the IUD strings will be examined 
and cut flush with the external os. In subjects post-cesarean, the IUD will be placed either 
manually, with ring forceps, or the Mirena inserter, to the uterine fundus. Care will be 
taken to avoid incorporation of IUD strings into the hysterotomy closure. If the IUD 
becomes dislodged during placement, the IUD will be removed and reinserted to the 
uterine fundus using sterile technique.  
c. Office IUD insertion: All insertions will be done according to the standard operating 
procedure at each clinic.  A variety of usual care providers will provide the device, and the 
placement is outside of the study procedure.  An exception will be subjects unable to 
obtain a device through their usual clinic.  These women may obtain a device through an 
investigator at Women’s Health Research Clinic.  All study investigators will undergo 
review of manufacturer instructions. Pain management will be per clinical judgment and 
includes either no treatment, 1% lidocaine gel applied directly to the cervix with a cotton 
swab, or 1-2 mL of 1% lidocaine injected into the cervix prior to tenaculum placement.  No 
paracervical block will be used unless clinically indicated. Dilation will be used if 
necessary. The IUD will be placed following FDA approved manufacturer instructions.  
 
12.  Study Visits 
a. Screening: Pregnant women with a history of poor prenatal clinic attendance and OHP or 
CAWEM insurance who have identified IUD as their planned form of contraception will be 
approached upon admission to OHSU Labor and Delivery by a study investigator. After a 
description of the study and confirmation of their intent for IUD, informed consent will be 
obtained, screening for study inclusion criteria will be performed, and the initial 
questionnaire will be administered if possible. Release of information will be signed 
including the subjects contact information so that they can be contacted at 3 months 
postpartum as detailed below.  
i. Subject screening 
ii. Informed Consent 
iii. Release of information  

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
iv.  Initial Questionnaire 
vi. Privacy Practices Information 
vii. Study Stipend Paperwork 
b. Randomization: Immediately after delivery the study subject randomization will be 
performed using sequential opaque envelopes. The subject will be informed of her group 
allocation and the study procedure will be reviewed. For participants randomized to 
insertion at their postpartum visit, an appointment will be scheduled with their primary 
provider prior to hospital discharge. If they are unable to obtain an IUD from their primary 
clinic, they will be given information to arrange IUD insertion at the OHSU Women’s 
Health Research Unit.  While placement at the WHRU is not “real world”, we feel that it 
this follow-up is ethically justified to provide the same option to all participants for a no cost 
IUD regardless of randomization group.  
i. Randomization revealed 
ii. Schedule follow up appointment if needed 
c. IUD placement(IUD insertion – postplacental or postpartum visit): Prior to IUD insertion, 
the provider will discuss informed consent with the patient and will sign a formal surgical 
consent form to be placed in the patient’s medical chart. The IUD will be inserted as detailed 
in study procedures. Subjects receiving postplacental IUDs will be encouraged to have the 
IUD strings checked at their postpartum visit by their primary provider. All subjects will be 
counseled on how to check their IUD strings. 
i. IUD insertion procedure 
d. Follow Up: At three months postpartum, participants will be contact by phone, text, or 
email. They will be asked whether they have had a known expulsion, pregnancy, or elective 
IUD removal. A brief questionnaire will include questions regarding ease of placement and 
overall satisfaction with the timing of placement. A study stipend will be provided at this 
time. Participants who did not follow up for IUD insertion or those that report IUD 
expulsion will be encouraged to contact their primary provider to discuss contraception. 
Chart review for confirmation of IUD placement will be performed. 
i. Final questionnaire 
ii. Study subject stipend paperwork 
 
13. Data Analysis: Data will be validated and entered into a computer. Statistical analysis 
will be carried out using STATA. Principal outcome measures include pregnancy and 
removal rates, cumulative expulsion, and continuation rates.  
 
14. Data management:All patient data sheets will be kept confidential and in a locked 
office. A unique patient study identification number will be placed on the data forms.  
Study identification will be subject last initial and a unique three digit identifier.  No 
subject names will be included with the study data. Study identifiers kept in a logbook 
will be assigned to each patient to protect confidentiality.  For subjects who do not enroll, 
all screening documents will be kept in a locked office and password protected computer 
and confidentially destroyed once study is complete. When undergoing statistical 
analysis, the forms will be transferred to the primary investigator’s locked office. Patient 
identifiers will be stored separately from the data files on the primary investigator’s 
password-protected computer. Only the study investigators will have access to this 
identifier list. 

OHSU IRB# 10473 
NCT No. NCT02169869 
Protocol Version 3.16.2017 
 
15. Compensation and costs for participation: All IUDs will be covered by the LARC 
program (a philanthropic program that provides no cost devices to women meeting 
eligibility criteria) or their Oregon Health Plan insurance. Subjects will be compensated 
$50 at the conclusion of the study after completion of the three month follow up phone 
call. 
 
16. Withdrawal: Subjects will have the right to withdraw from the trial at any time on 
their own request for any reason.  The reason for withdrawal will be recorded in detail. 
Subject who choose to withdrawal from the study will be contacted for follow up to 
complete the three-month follow up questionnaire. Additionally, any data obtained up to 
the point of withdrawal will be analyzed in accordance with intention to treat. 
 
17. Non-English speaking participants: Consent forms will be translated into Spanish 
by a certified interpreter.  Telephone calls to subjects will be completed with the 
assistance of a certified OHSU interpreter.   
 
18. References 
 
1. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the 
United States, 1994 and 2001. Perspect Sex Reprod Health. 2006; 38:90–6. 
[PubMed: 16772190] 
2. Statistics NCfH. National Survey of Family Growth. In: Control CfD, ed. 
Hyattsville, MD: Health Indicators Warehouse; 2006-2008. 
3. Ogburn JA, Espey E, Stonehocker J. Barriers to intrauterine device insertion in 
postpartum women. Contraception. 2005; 72:426–9.  
4. Grimes DA, Lopez LM, Schulz KF, Van Vliet H, Stanwood NL. Immediate post-
partum insertion of intrauterine devices. Cochrane Database Syst Rev 2010:1–15, 
http://dx.doi.org/10.1002/14651858.CD003036.pub2 Issue 5. Art. No.: 
CD003036. 
5. Chen, BA, Reeves, MF, Creinin, MD, & Schwarz, EB. Postplacental or delayed 
levonorgestrel intrauterine device insertion and breast-feeding duration. 
Contraception, 2011. 84(5), 499-504. 
6. Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, & Creinin MD. 
Postplacental or delayed insertion of the Levonorgestrel Intrauterine Device after 
vaginal delivery: a randomized controlled trial.  Obstetrics and Gynecology. 2010. 
116 (5): 1079-1087.  
7. Morrison C, Waszak C, Katz K, Diabate F, Mate EM. Clinical outcomes of two 
early postpartum IUD insertion programs in Africa. Contraception 1996;53:17–
21. 
8. Simmons, KB, Edelman, AB, Li, H, Yanit, KE, & Jensen, JT. Personalized 
contraceptive assistance and uptake of long-acting, reversible contraceptives by 
postpartum women: a randomized, controlled trial, Contraception 2013. 88(1):45-
51. 

OHSU IRB# 10473 
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Protocol Version 3.16.2017 
9. Baldwin, M, et al. Early versus standard interval postpartum Intrauterine Device 
(IUD) placement at 3 weeks or 6 weeks following delivery: A prospective 
randomized trial. (abstract).