Postpartum Etonogestrel Implant for Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial

Conditions
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Adolescence, Contraception, Postpartum

Intervention / Treatment
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* Drug: Contraceptive implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 week postpartum contraceptive implant<br>randomized to receive contraceptive implant at normal 6 week postpartum visit | Drug: Contraceptive implant<br> <br> * Other names: Implanon, Nexplanon, etonogestrel contraceptive implant;|
| Experimental: Immediate postpartum contraceptive implant<br>randomized to receive contraceptive implant prior to leaving the hospital postpartum | Drug: Contraceptive implant<br> <br> * Other names: Implanon, Nexplanon, etonogestrel contraceptive implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation at 1 Year | The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum. | 12-14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being not satisfied at all to 10 being extremely satisfied. | 12 months | 
| Rapid Repeat Pregnancy | To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, adolescence, contraception, rapid repeat pregnancy