Antepartum Etonogestrel Contraceptive Implant Insertion at Term

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception
• Intervention / Treatment: Drug: Etonogestrel 68Mg Implant

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Etonogestrel Contraceptive; 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.	Drug: Etonogestrel 68Mg Implant; 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.; Other Names: NEXPLANON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal and cord blood serum etonogestrel concentration	Maternal and cord blood serum etonogestrel concentratration	Delivery

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Aaron Lazorwitz, MD, University of Colorado - Denver Anschutz

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): April 15, 2019

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (ACTUAL): September 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Contraception; Etonogestrel implant
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Etonogestrel
• Other Study ID Numbers: 18-0197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No