Antepartum Etonogestrel Contraceptive Implant Insertion at Term

Phase 1

Withdrawn

• Conditions: Contraception
• Interventions: Drug: Etonogestrel 68Mg Implant

• Registration Number: NCT03656289
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Study Start: 2019-01-01
• Status Verified: 2019-04
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etonogestrel Contraceptive	Etonogestrel 68Mg Implant	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.

Primary Outcome Measures

Name	Time	Method
Maternal and cord blood serum etonogestrel concentration	Delivery	Maternal and cord blood serum etonogestrel concentratration

Secondary Outcome Measures

Name	Time	Method
Gestational age at time of delivery	Delivery	Gestational age at time of delivery
Onset of lactogenesis	5-10 days postpartum (Follow Up Visit 1)	Stage II of lactation
Questionnaire: Continuation of contraceptive implant use	6 months postpartum (Follow Up Visit 3)	Assess continuation of the contraceptive implant
Questionnaire: Satisfaction with contraceptive implant	6 months postpartum (Follow Up Visit 3)	Assess satisfaction with the contraceptive implant

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States