NCT03656289

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

August 23, 2018

Last Update Submit

April 15, 2019

Conditions

Contraception

Keywords

ContraceptionEtonogestrel implant

Outcome Measures

Primary Outcomes (1)

  • Maternal and cord blood serum etonogestrel concentration

    Maternal and cord blood serum etonogestrel concentratration

    Delivery

Secondary Outcomes (6)

  • Gestational age at time of delivery

    Delivery

  • Onset of lactogenesis

    5-10 days postpartum (Follow Up Visit 1)

  • Questionnaire: Continuation of contraceptive implant use

    3 months postpartum (Follow Up Visit 2)

  • Questionnaire: Satisfaction with contraceptive implant

    3 months postpartum (Follow Up Visit 2)

  • Questionnaire: Continuation of contraceptive implant use

    6 months postpartum (Follow Up Visit 3)

  • +1 more secondary outcomes

Study Arms (1)

Etonogestrel Contraceptive

EXPERIMENTAL

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

Interventions

Etonogestrel 68Mg ImplantDRUG

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.

Also known as: NEXPLANON
Etonogestrel Contraceptive

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWe are only enrolling women in this study as we are studying the acceptability of a contraceptive device during pregnancy and so this study is not appropriate for men.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

etonogestrelDrug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Aaron Lazorwitz, MD

    University of Colorado - Denver Anschutz

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

September 4, 2018

Study Start

January 1, 2019

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)