Not provided
Not provided
Not provided
Not provided
Not provided
IND approval from FDA was rejected and IRB approval was never granted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etonogestrel Contraceptive | Experimental | Etonogestrel contraceptive implant; consists of a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel, pre-loaded in the needle of a disposable applicator. The implant must be removed no later than by the end of the third year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel 68Mg Implant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal and cord blood serum etonogestrel concentration | Maternal and cord blood serum etonogestrel concentratration | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at time of delivery | Gestational age at time of delivery | Delivery |
| Onset of lactogenesis | Stage II of lactation | 5-10 days postpartum (Follow Up Visit 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
We are only enrolling women in this study as we are studying the acceptability of a contraceptive device during pregnancy and so this study is not appropriate for men.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aaron Lazorwitz, MD | University of Colorado - Denver Anschutz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C044815 | etonogestrel |
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Questionnaire: Continuation of contraceptive implant use | Assess continuation of the contraceptive implant | 3 months postpartum (Follow Up Visit 2) |
| Questionnaire: Satisfaction with contraceptive implant | Assess satisfaction with the contraceptive implant | 3 months postpartum (Follow Up Visit 2) |
| Questionnaire: Continuation of contraceptive implant use | Assess continuation of the contraceptive implant | 6 months postpartum (Follow Up Visit 3) |
| Questionnaire: Satisfaction with contraceptive implant | Assess satisfaction with the contraceptive implant | 6 months postpartum (Follow Up Visit 3) |