Antepartum Etonogestrel Contraceptive Implant Insertion at Term

Study Overview
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Brief Summary
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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.

Official Title
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Antepartum Etonogestrel Contraceptive Implant Insertion at Term: an Acceptability and Pharmacokinetic Pilot Study

Conditions
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Contraception

Intervention / Treatment
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* Drug: Etonogestrel 68Mg Implant


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etonogestrel Contraceptive<br>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<br>* 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.<br>* Other names: NEXPLANON;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Etonogestrel implant