Contraception
Conditions
Keywords
Contraception, Etonogestrel implant
Brief summary
Short-interval pregnancy (SIP) or rapid, repeat pregnancy is defined as a pregnancy within one year of prior delivery. These pregnancies are often unintended and are associated with adverse risks. Low contraceptive initiation during the postpartum period is a contributing factor to SIP. This study will be the first to investigate the initiation of a highly-effective, immediately active contraceptive device during the antepartum period. The antepartum period serves as an ideal time for postpartum contraception counseling, due to patients' active involvement with the healthcare system. The pharmacokinetic analysis proposed in this study will be the first to investigate whether and to what extent ENG hormone crosses the placenta. This data will enrich understanding of the pharmacology of exogenous progestins administered during pregnancy and provide information that can be incorporated into future patient counseling regarding the risks of fetal exposure with exogenous progestin use.
Interventions
Participants will have an etonogestral contraceptive implant (NEXPLANON) placed sub-dermally just under the skin at the inner side of the non-dominant upper arm.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women (ages 18-34 years) ≥37 weeks gestational age who are interested in using an ENG contraceptive implant for their postpartum birth control method. * Women with a history of at least one uncomplicated vaginal delivery at term who have received routine prenatal care (at least five visits) including an anatomy ultrasound with confirmed dating.
Exclusion criteria
* Women outside the gestational age outlined above. * Women who are seen outside of the enrolling clinics. * Women 35 years and older at the time of anticipated delivery, as these women meet the clinical definition of advanced maternal age which has been associated with increased adverse events in pregnancy. * Women with any condition that necessitates a medically indicated delivery (e.g. diabetes mellitus, any hypertensive disorder), multiple gestations, fetal anomalies, Class III obesity (body mass index \>40), concurrent use of either an injectable or vaginal progestin, and any concerns related to ENG implant use based on the US Medical Eligibility Criteria for Contraceptive Use (defined as a class 3 or 4 recommendation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal and cord blood serum etonogestrel concentration | Delivery | Maternal and cord blood serum etonogestrel concentratration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at time of delivery | Delivery | Gestational age at time of delivery |
| Onset of lactogenesis | 5-10 days postpartum (Follow Up Visit 1) | Stage II of lactation |
| Questionnaire: Continuation of contraceptive implant use | 3 months postpartum (Follow Up Visit 2) | Assess continuation of the contraceptive implant |
| Questionnaire: Satisfaction with contraceptive implant | 3 months postpartum (Follow Up Visit 2) | Assess satisfaction with the contraceptive implant |
Countries
United States
Outcome results
None listed