Antepartum Etonogestrel Contraceptive Implant Insertion at Term

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03656289
• Other study ID #: 18-0197
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 1, 2019
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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).

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and cord blood serum etonogestrel concentration	Maternal and cord blood serum etonogestrel concentratration	Delivery
Secondary	Gestational age at time of delivery	Gestational age at time of delivery	Delivery
Secondary	Onset of lactogenesis	Stage II of lactation	5-10 days postpartum (Follow Up Visit 1)
Secondary	Questionnaire: Continuation of contraceptive implant use	Assess continuation of the contraceptive implant	3 months postpartum (Follow Up Visit 2)
Secondary	Questionnaire: Satisfaction with contraceptive implant	Assess satisfaction with the contraceptive implant	3 months postpartum (Follow Up Visit 2)
Secondary	Questionnaire: Continuation of contraceptive implant use	Assess continuation of the contraceptive implant	6 months postpartum (Follow Up Visit 3)
Secondary	Questionnaire: Satisfaction with contraceptive implant	Assess satisfaction with the contraceptive implant	6 months postpartum (Follow Up Visit 3)