Adolescence, Contraception, Postpartum
Conditions
Keywords
adolescence, contraception, postpartum, rapid repeat pregnancy
Brief 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.
Interventions
DRUGContraceptive implant
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 Week Postpartum Contraceptive Implant randomized to receive contraceptive implant at normal 6 week postpartum visit
Contraceptive implant | 48 |
| Immediate Postpartum Contraceptive Implant randomized to receive contraceptive implant prior to leaving the hospital postpartum
Contraceptive implant | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | 6 Week Postpartum Contraceptive Implant | Total | Immediate Postpartum Contraceptive Implant |
|---|---|---|---|
| Age, Continuous | 21 years STANDARD_DEVIATION 2.58 | 21 years STANDARD_DEVIATION 2.4 | 21 years STANDARD_DEVIATION 2.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 38 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 26 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 34 Participants | 67 Participants | 33 Participants |
| Region of Enrollment United States | 48 participants | 96 participants | 48 participants |
| Sex: Female, Male Female | 48 Participants | 96 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
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.
Time frame: 12-14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 Week Postpartum Contraceptive Implant | Continuation at 1 Year | 21 participants |
| Immediate Postpartum Contraceptive Implant | Continuation at 1 Year | 30 participants |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 Week Postpartum Contraceptive Implant | Rapid Repeat Pregnancy | 2 participants |
| Immediate Postpartum Contraceptive Implant | Rapid Repeat Pregnancy | 5 participants |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Week Postpartum Contraceptive Implant | Satisfaction | 8.68 units on a scale | Standard Deviation 1.36 |
| Immediate Postpartum Contraceptive Implant | Satisfaction | 8.29 units on a scale | Standard Deviation 2.14 |