Immediate Postplacental IUD Insertion
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/15/2019 |
| Start Date: | September 2014 |
| End Date: | December 2019 |
Immediate Postplacental Intrauterine Device Insertion in High-risk Patient Populations
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 Intrauterine Device (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 Oregon
Health and Science University (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. Immediately after vaginal or cesarean delivery, consented 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. 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 (WHRU) 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.
2 or more no show visits who desire an Intrauterine Device (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 Oregon
Health and Science University (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. Immediately after vaginal or cesarean delivery, consented 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. 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 (WHRU) 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.
Inclusion Criteria:
- Female
- 18 yo or older
- Singleton pregnancy at ≥32 weeks gestation at time of enrollment
- Voluntarily requesting either copper T380A or levonorgestrel IUD (LNG-IUS) placement
for postpartum contraception
- English or Spanish speaking
- Able to give consent and agree to the terms of the study
- Less than 10 prenatal visits or 2 or more no show visits
- Since IUDs are not on our hospital formulary, the patient must qualify for a Long
Acting Reversible Contraceptive (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).
Exclusion Criteria:
- Anatomic uterine abnormalities that prevent proper fundal placement of IUD
(obstructive myomata, bicornuate, septate, etc)
- Chorioamnionitis (also consider other risk factors such as prolonged rupture of
membranes >18 hours, prolonged labor >24 hours, fever >38C)
- Puerperal sepsis
- Unresolved postpartum hemorrhage
- Extensive genital trauma
- Current incarceration
- Known or suspected untreated endocervical gonorrhea, chlamydia
- Wilson's disease, copper allergy (Paragard only)
- Known or suspected cervical or endometrial cancer or pelvic tuberculosis
- Current breast cancer (LNG-IUS only)
- Systemic lupus erythematosus (SLE) with severe thrombocytopenia (Paragard only)
- Trophoblastic disease (benign or malignant)
- AIDS not stable on antiretroviral
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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