Early Postpartum Intrauterine Device (IUD) Placement

NCT01594476 | Terminated Phase 4 Results DMC

• 1 other identifier: 8120
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement

Conditions

Contraception

Keywords

Postpartum; Contraception; Intrauterine device; Intrauterine system; Mirena; Paragard; Uterine involution

Outcome Measures

Primary Outcomes (1)

• Subjects With an IUD at 3 Months Postpartum

  Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .

  Three months after delivery

Secondary Outcomes (5)

• Satisfaction With the Timing of IUD Placement.

  Immediately following IUD placement.

• Uterine Thickness at the Fundus

  At IUD placement

• Subjects With an IUD at 6 Months Postpartum

  Six months after delivery

• Number of Subjects With Adverse Events

  Six months after delivery

• Pain With IUD Placement

  At the time of IUD placement.

Study Arms (2)

Levonorgestrel IUS insertion at 3 weeks

EXPERIMENTAL

IUD placement at 3 weeks after delivery.

Drug: Levonorgestrel IUS

Levonorgestrel IUS insertion at 6 weeks

EXPERIMENTAL

IUD placement at 6 weeks after delivery.

Drug: Levonorgestrel IUS

Interventions

Levonorgestrel IUS DRUG

20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device

Also known as: Mirena IUS, Paragard IUD

Levonorgestrel IUS insertion at 3 weeks; Levonorgestrel IUS insertion at 6 weeks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years or older
• Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception
• Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment
• English or Spanish speaking
• Able to give consent and agree to terms of the study
• No contraindications to use of either intrauterine device

You may not qualify if:

• Preterm delivery prior to 32 weeks gestation
• Recent pregnancy with multiple gestation
• Current incarceration
• Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
• Suspected hypersensitivity or contraindication to the chosen IUD
• No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.

  PMID: 29750924 DERIVED

Results Point of Contact

• Title: Dr. Maureen Baldwin, MD MPH
• Organization: Oregon Health & Science University

schaum@ohsu.edu

(503) 494-9762

Study Officials

• Maureen Baldwin, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Ob/Gyn, Fellow in Family Planning

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: May 9, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 11, 2019
• Results First Posted: January 11, 2019

Record last verified: 2019-01

Locations

US (1)