PPImplantEtonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
Contraceptive implant
+ Contraceptive implant
Prevention Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 14 to 24 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Adolescents ages 14-24 attending prenatal care Greater than 20 weeks estimated gestational age English or Spanish-speaking Desire to use the contraceptive implant for contraception postpartum Anticipated delivery of a healthy infant vaginally or by cesarean. Exclusion Criteria: Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including current or past history of thrombosis or thromboembolic disorders hepatic tumors (benign or malignant) active liver disease undiagnosed abnormal genital bleeding known or suspected carcinoma of the breast (or a personal history of breast cancer) hypersensitivity to any of the components of the contraceptive implant. Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate Characteristics that would preclude involvement after delivery: Birth of a stillborn infant. Maternal ICU admission after delivery Maternal postpartum hemorrhage requiring blood transfusion Prolonged hospital stay (>7 days) postpartum Coagulopathy associated with the pregnancy Severe pregnancy-induced hypertension Fever >38 degrees C postpartum Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of North Carolina Hospitals
Chapel Hill, United StatesOpen University of North Carolina Hospitals in Google Maps