drugset / Trial / NCT03656289

Antepartum Etonogestrel Contraceptive Implant Insertion at Term

NCT03656289

Phase 1 Withdrawn University of Colorado, Denver
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2019-01-01
Primary completion
2019-04-15
Completion
2019-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Etonogestrel Unknown 68 mg Subcutaneous

Indications

No indication recorded.