Contraception Clinical Trial
Official title:
Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone
of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women
initiate use of this method in the post partum period. The major advantage of immediate
postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive
method at a time that does not interfere with the intense demands of newborn care, but any
contraceptive method initiated in the postpartum period must not interfere with
breastfeeding.
Our long-term goal is to understand the impact of hormonal contraceptives, initiated early
in the postpartum period, on breastfeeding. The central hypothesis is that quality of
breastfeeding is not negatively affected by progestin-only hormonal contraceptives.
We will pursue three specific aims comparing women randomized to immediate post-placental
vs. delayed (4-6 week) postpartum LNG IUD insertion:
Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To
determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding
continuation, exclusivity, and satisfaction as well as continuation and satisfaction with
the LNG IUD at 26 weeks postpartum in both groups
This proposal will support a non-inferiority RCT where participants will be randomly
assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or
delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed
evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.
;
| 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 |