NCT03925116

Brief Summary

Women seeking contraception will be randomized to "usual care" or to a "Contraceptive Pathway"

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
3.7 years until next milestone

Study Start

First participant enrolled

January 3, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

March 26, 2019

Last Update Submit

May 2, 2022

Conditions

Keywords

contraceptive pathwaycontinuation

Outcome Measures

Primary Outcomes (1)

  • Continued Use of Contraception at 1 year

    The difference in contraception continuation rates will be compared between the Contraceptive Pathway group and the Usual care group, based on follow up phone calls at 3 weeks, 6 months and 1 year

    1 year

Secondary Outcomes (2)

  • Subject satisfaction with contraceptive counseling

    at initial office visit/immediate

  • Pregnancy rates

    1 year

Study Arms (2)

usual care

NO INTERVENTION

women who present for birth control to the gynecology office will see their physician in the usual fashion for review, counseling and contraception decision/initiation. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation.

Contraceptive pathway

EXPERIMENTAL

Women who present for birth control to the gynecology office will be recognized by the front desk and offered a tablet which which will: 1. collect relevant medical history 2. provide educational material on birth control options 3. provide a link to bedsider.com for further information They will then discuss the tablet information/history with the medical assistant, who will answer any remaining questions. They will then see the physician/APN. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation.

Other: COntraceptive pathway

Interventions

alternative way of aiding patients in deciding contraception method

Contraceptive pathway

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women at risk for pregnancy
  • Women able to read and write in English

You may not qualify if:

  • Women who have undergone permanent sterilization
  • Women not sexually active with a male partner
  • Women who intend to become pregnant in the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Academic Building. 125 Paterson Street

New Brunswick, New Jersey, 08901, United States

Location

Related Links

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Adrian C Balica, MD

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dept. Ob/Gyn, RWJMS

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 23, 2019

Study Start

January 3, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations