Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
| Registry | NCT01666912, acronym PPImplant |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 96 (Actual) |
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| Sponsor | University of North Carolina, Chapel Hill (Other) |
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| Conditions | Adolescence, Contraception, Postpartum |
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| Interventions | Contraceptive implant (Drug) |
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| Dates | start 2012-08-01, primary completion 2015-04-01, completion 2015-04-01, first posted 2012-08-16, last updated 2017-05-01 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Adolescence All trials for Contraception All trials of Contraceptive implant
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| 6 week postpartum contraceptive implant | Active comparator | Drug: Contraceptive implant | randomized to receive contraceptive implant at normal 6 week postpartum visit |
| Immediate postpartum contraceptive implant | Experimental | Drug: Contraceptive implant | randomized to receive contraceptive implant prior to leaving the hospital postpartum |
- Contraceptive implant (Drug), also known as Implanon, Nexplanon, etonogestrel contraceptive implant
+Outcome measures
Primary outcomes
- Continuation at 1 Year [12-14 months]: 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.
Secondary outcomes
- Satisfaction [12 months]: 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."
- Rapid Repeat Pregnancy [12 months]: To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.
+Eligibility
Sex: Female, ages: 14 Years to 24 Years, accepts healthy volunteers
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
+Posted results
Participant flow
| Milestone | 6 Week Postpartum Contraceptive Implant | Immediate Postpartum Contraceptive Implant |
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| Started | 48 | 48 |
| Completed | 27 | 37 |
| Not completed | 21 | 11 |
Outcome results
- Continuation at 1 Year (Primary), Number, participants: 6 Week Postpartum Contraceptive Implant 21; Immediate Postpartum Contraceptive Implant 30
- Satisfaction (Secondary), Mean, units on a scale: 6 Week Postpartum Contraceptive Implant 8.68 +/- 1.36; Immediate Postpartum Contraceptive Implant 8.29 +/- 2.14
- Rapid Repeat Pregnancy (Secondary), Number, participants: 6 Week Postpartum Contraceptive Implant 2 (1 to 5); Immediate Postpartum Contraceptive Implant 5 (4 to 6)
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| 6 Week Postpartum Contraceptive Implant | 0 | 0/48 (0.0%) | 0/48 (0.0%) |
| Immediate Postpartum Contraceptive Implant | 0 | 0/48 (0.0%) | 0/48 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| University of North Carolina Hospitals | Chapel Hill, North Carolina | United States | |