Contraception Clinical Trial
Official title:
Feasibility Trial of Hormonal Contraceptive Initiation Program in the Pediatric Emergency Department
Many female adolescents using the pediatric emergency department (ED) are at higher risk for unintended pregnancy. This is a significant public health issue and hormonal contraception is the mainstay of prevention. Many barriers to hormonal contraception exist and other studies have demonstrated that referral from the ED for hormonal contraception leads to poor follow up. This study will be a pilot study to assess the feasibility of initiating hormonal contraception in the pediatric ED.
This study will assess the feasibility of initiating hormonal contraception in the pediatric ED. Currently, all 15-21-year-old patients receiving care in our ED are asked to complete an adolescent heath questionnaire to identify risk-factors for sexually transmitted infections (STIs). Sexually active female patients who indicate on this questionnaire they are not currently using hormonal contraception will be eligible for participation in this study. Potential participants will be screened using the EMR and eligible patients will be approached. Consent will be obtained from adults directly and from a parent or guardian for minors that have one present. For minors that present without a parent or guardian, assent only with be obtained from the minor. Participants will be randomized into two groups, an intervention group and a control group. Participants in both groups will be given tablet computer and, through a software application on the tablet, answer questions electronically about their background, medical history, and contraceptive preferences. They will then be shown a video that provides an overview of hormonal contraceptive options. Depending on the participants medical history and contraceptive preferences, they may be offered more in-depth educational videos about specific types of hormonal contraception for which they are eligible (e.g. pill, transdermal patch, intravaginal ring, injection, and implant). Once they have completed watching the videos, participants in the intervention group will have the option of initiating one of the offered forms of birth control during the ED visit. They will only be offered medications considered low risk and for which they do not have any medical contraindications. Urine pregnancy testing will be done before any method is given. They will be able to start any contraceptive method from among those offered after their screening. Participants in the control group will be offered outpatient referral to initiate contraception, the current standard of care in our ED. All patients in both arms of the study will be given referral/follow up options for further contraceptive care. All participants in this study will then be followed up at 1, 3, 6, and 12 months to determine continuation of contraception practices, follow up practices, satisfaction, and pregnancy rates. ;
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 |