Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02121067
Other study ID # 14-0202
Secondary ID
Status Recruiting
Phase Phase 4
First received March 24, 2014
Last updated April 6, 2015
Start date September 2014
Est. completion date January 2016

Study information

Verified date April 2015
Source University of North Carolina, Chapel Hill
Contact Matthew L Zerden, MD, MPH
Phone 919-843-5633
Email Matthew_Zerden@med.unc.edu
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

1. Desiring a LNG-IUS

2. Postpartum, ages 18-45 who deliver at a gestational age > 32 weeks, delivery can be via cesarean or vaginal delivery

3. Following a viable, singleton pregnancy

4. Willing to return to UNC for their LNG-IUS insertion and study follow-up

5. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits

6. Fluent in English or Spanish

7. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)

Exclusion Criteria:

1. No genital bleeding of unknown etiology

2. No personal history of known or suspected breast carcinoma

3. No 4th degree vaginal laceration at time of delivery

4. No documented uterine rupture during delivery

5. No active liver disease (resolved pre-eclampsia may enroll)

6. No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion

7. No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage

8. No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4

9. Not currently incarcerated

10. No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity

11. No suspected hypersensitivity or contraindication to the LNG-IUS

12. With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Levonorgestrel Intrauterine System (LNG-IUS)
The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To report the acceptability of receiving an LNG-IUS two-weeks postpartum. A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend". 6 months postpartum No
Secondary To estimate the expulsion rate (complete or partial) at six months of LNG-IUS placed at two-weeks postpartum. Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix. 6 months postpartum Yes
Secondary To assess the pain experience of LNG-IUS insertion. To assess the pain experience of LNG-IUS insertion. immediately following placement No
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 NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
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
Completed NCT02234271 - Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information N/A