Clinical trial NCT03656289: Antepartum Etonogestrel Contraceptive Implant Insertion at Term
Official title: Antepartum Etonogestrel Contraceptive Implant Insertion at Term: an Acceptability and Pharmacokinetic Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Contraception
Keywords: Contraception
Etonogestrel implant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Maternal and cord blood serum etonogestrel concentration
timeFrame: Delivery
Secondary outcomes:
measure: Gestational age at time of delivery
timeFrame: Delivery
measure: Onset of lactogenesis
timeFrame: 5-10 days postpartum (Follow Up Visit 1)
measure: Questionnaire: Continuation of contraceptive implant use
timeFrame: 3 months postpartum (Follow Up Visit 2)
measure: Questionnaire: Satisfaction with contraceptive implant
timeFrame: 3 months postpartum (Follow Up Visit 2)
measure: Questionnaire: Continuation of contraceptive implant use
timeFrame: 6 months postpartum (Follow Up Visit 3)
measure: Questionnaire: Satisfaction with contraceptive implant
timeFrame: 6 months postpartum (Follow Up Visit 3)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado - Denver Anschutz
name: Aaron Lazorwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: