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Antepartum Etonogestrel Contraceptive Implant Insertion at Term

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ClinicalTrials.gov Identifier: NCT03656289
Recruitment Status : Not yet recruiting
First Posted : September 3, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Etonogestrel 68Mg Implant Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antepartum Etonogestrel Contraceptive Implant Insertion at Term: an Acceptability and Pharmacokinetic Pilot Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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 Name: NEXPLANON




Primary Outcome Measures :
  1. Maternal and cord blood serum etonogestrel concentration [ Time Frame: Delivery ]
    Maternal and cord blood serum etonogestrel concentratration


Secondary Outcome Measures :
  1. Gestational age at time of delivery [ Time Frame: Delivery ]
    Gestational age at time of delivery

  2. Onset of lactogenesis [ Time Frame: 5-10 days postpartum (Follow Up Visit 1) ]
    Stage II of lactation

  3. Questionnaire: Continuation of contraceptive implant use [ Time Frame: 3 months postpartum (Follow Up Visit 2) ]
    Assess continuation of the contraceptive implant

  4. Questionnaire: Satisfaction with contraceptive implant [ Time Frame: 3 months postpartum (Follow Up Visit 2) ]
    Assess satisfaction with the contraceptive implant

  5. Questionnaire: Continuation of contraceptive implant use [ Time Frame: 6 months postpartum (Follow Up Visit 3) ]
    Assess continuation of the contraceptive implant

  6. Questionnaire: Satisfaction with contraceptive implant [ Time Frame: 6 months postpartum (Follow Up Visit 3) ]
    Assess satisfaction with the contraceptive implant



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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We 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.
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656289


Contacts
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Contact: Eva Dindinger, BA 303-724-8482 eva.dindinger@ucdenver.edu
Contact: Rebecca Seale, MA 303-724-2013 rebecca.seale@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Eva Dindinger, BA    303-724-8482    Eva.Dindinger@ucdenver.edu   
Contact: Rebecca Seale, MA    303-724-2013    rebecca.seale@ucdenver.edu   
Principal Investigator: Aaron Lazorwitz, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Aaron Lazorwitz, MD University of Colorado - Denver Anschutz

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03656289     History of Changes
Other Study ID Numbers: 18-0197
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Contraception
Etonogestrel implant

Additional relevant MeSH terms:
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Contraceptive Agents
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists