Antepartum Etonogestrel Contraceptive Implant Insertion at Term
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 34 |
| Updated: | 1/6/2019 |
| Start Date: | May 2019 |
| End Date: | January 1, 2020 |
| Contact: | Eva Dindinger, BA |
| Email: | eva.dindinger@ucdenver.edu |
| Phone: | 303-724-8482 |
Antepartum Etonogestrel Contraceptive Implant Insertion at Term: an Acceptability and Pharmacokinetic Pilot Study
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.
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.
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).
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Aaron Lazorwitz, MD
Phone: 303-724-8482
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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