Early Postpartum Intrauterine Device (IUD) Placement

Status Terminated

Clinical Trial 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

Clinical Trial Description

The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months. ;

Study Design

Related Conditions & MeSH terms

Contraception

Clinical Trial Details

NCT number	NCT01594476
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Terminated
Phase	Phase 4
Start date	March 2012
Completion date	July 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02577601` - Impact of Combined Hormonal Contraceptives on UPA	Phase 4
Completed	`NCT03153644` - Improving Contraceptive Care for Women With Medical Conditions
Completed	`NCT04112095` - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use	Phase 3
Recruiting	`NCT05521646` - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative	N/A
Active, not recruiting	`NCT04291001` - Ovarian Function With ENG Implant and UPA Use	Early Phase 1
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed	`NCT03438682` - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting	`NCT01948882` - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women	N/A
Enrolling by invitation	`NCT04997499` - Adolescent Subcutaneous (SQ) Injection Video Validation	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03154125` - Sayana® Press Extension Study	Phase 3
Withdrawn	`NCT03725358` - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.	N/A
Completed	`NCT02957630` - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"	Phase 1/Phase 2
Completed	`NCT02718222` - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services	N/A
Completed	`NCT02456584` - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods	Phase 1
Recruiting	`NCT02121067` - LNG-IUS at 2 Weeks Postpartum	Phase 4
Terminated	`NCT02169869` - Immediate Postplacental IUD Insertion	N/A
Recruiting	`NCT02292056` - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions	N/A
Withdrawn	`NCT01930994` - Kenya Sino-implant (II) PK Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.