Nexplanon Application Post-Abortion (NAPA)

NCT ID: NCT02037919

Last Updated: 2024-02-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-05-31

Brief Summary

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Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.

Detailed Description

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Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Conditions

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Contraception Abortion, Therapeutic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Immediate Nexplanon Insertion

An etonogestrel rod will be placed within 15 minutes following the abortion procedure.

Group Type EXPERIMENTAL

Immediate Nexplanon Insertion

Intervention Type OTHER

Patient will have a Nexplanon inserted within 15 minutes of her abortion

Post-op Nexplanon Insertion

Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.

Group Type ACTIVE_COMPARATOR

Post-op Nexplanon Insertion

Intervention Type OTHER

Place Nexplanon at post operative visit rather than at surgery

Interventions

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Immediate Nexplanon Insertion

Patient will have a Nexplanon inserted within 15 minutes of her abortion

Intervention Type OTHER

Post-op Nexplanon Insertion

Place Nexplanon at post operative visit rather than at surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older,
* an intrauterine pregnancy \> 14 weeks and \<23 6/7 weeks gestation and desire termination of pregnancy
* desire a Nexplanon for contraception
* able to give informed consent in English
* no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D\&E

Exclusion Criteria

* unable to give informed consent
* have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
* non-surgical management of pregnancy
* prior participation in this study
* breast cancer or a history of breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Family Planning Associates Medical Group, LTD

OTHER

Sponsor Role lead

Responsible Party

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Allison Cowett, MD MPH

Associate Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Cremer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Family Planning Associates Medical Grooup, LTD

Chicago, Illinois, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IIS#50302: Women's Health MISP

Identifier Type: -

Identifier Source: org_study_id

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