NCT02380781

Brief Summary

This is a prospective randomized control trial in which we propose an intervention in the immediate post-partum period to educate women about contraceptive options, particularly long acting reversible contraception (LARC) methods with an aim of increasing the amount of women who choose a LARC method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

March 1, 2015

Last Update Submit

June 30, 2022

Conditions

Postpartum Contraceptive Counseling

Outcome Measures

Primary Outcomes (1)

  • Choice of contraceptive method

    Will be obtained through use of a questionnaire.

    24 hours post-intervention

Secondary Outcomes (2)

  • Return to clinic for postpartum visit

    12 weeks post-intervention

  • Obtained desired method of contraception

    12 weeks post-intervention

Study Arms (2)

Control

NO INTERVENTION

Patients will receive current standard postpartum contraceptive counseling.

Intervention

EXPERIMENTAL

Patients will receive current standard postpartum contraceptive counseling and will be shown a 10 minute video from the CHOICE project which outlines the different contraceptive options

Behavioral: Information in the form of a video

Interventions

Information in the form of a videoBEHAVIORAL

see intervention description

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women giving birth at University Hospitals Case Medical Center
  • Patient of the Women's Health Center
  • Women delivering only one child
  • Women receiving contraceptive counseling from the nurse practitioner that cares for the postpartum unit

You may not qualify if:

  • Severe neonatal complication at time of delivery (neonatal death, neonatal admission to the neonatal intensive care unit (NICU) except in cases of chorioamnionitis)
  • Severe maternal complication at time of delivery (patient requiring intensive care unit care, patient requiring hysterectomy at time of delivery)
  • Preterm delivery \<34 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (15)

  • Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011 Nov;84(5):478-85. doi: 10.1016/j.contraception.2011.07.013. Epub 2011 Aug 24.

    PMID: 22018121BACKGROUND

  • Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Effects of birth spacing on maternal health: a systematic review. Am J Obstet Gynecol. 2007 Apr;196(4):297-308. doi: 10.1016/j.ajog.2006.05.055.

    PMID: 17403398BACKGROUND

  • Thiel de Bocanegra H, Chang R, Howell M, Darney P. Interpregnancy intervals: impact of postpartum contraceptive effectiveness and coverage. Am J Obstet Gynecol. 2014 Apr;210(4):311.e1-311.e8. doi: 10.1016/j.ajog.2013.12.020. Epub 2013 Dec 13.

    PMID: 24334205BACKGROUND

  • Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

    PMID: 20541171BACKGROUND

  • Rose SB, Lawton BA. Impact of long-acting reversible contraception on return for repeat abortion. Am J Obstet Gynecol. 2012 Jan;206(1):37.e1-6. doi: 10.1016/j.ajog.2011.06.102. Epub 2011 Jul 13.

    PMID: 21944222BACKGROUND

  • Madden T, Mullersman JL, Omvig KJ, Secura GM, Peipert JF. Structured contraceptive counseling provided by the Contraceptive CHOICE Project. Contraception. 2013 Aug;88(2):243-9. doi: 10.1016/j.contraception.2012.07.015. Epub 2012 Sep 5.

    PMID: 22959396BACKGROUND

  • Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.

    PMID: 21508749BACKGROUND

  • Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril. 2012 Oct;98(4):893-7. doi: 10.1016/j.fertnstert.2012.06.027. Epub 2012 Jul 13.

    PMID: 22795639BACKGROUND

  • Randel A. Guidelines for the use of long-acting reversible contraceptives. Am Fam Physician. 2012 Feb 15;85(4):403-4. No abstract available.

    PMID: 22335322BACKGROUND

  • Zuckerman B, Nathan S, Mate K. Preventing unintended pregnancy: a pediatric opportunity. Pediatrics. 2014 Feb;133(2):181-3. doi: 10.1542/peds.2013-1147. Epub 2014 Jan 27. No abstract available.

    PMID: 24470643BACKGROUND

  • American Academy of Pediatrics Committee on Adolescence: Contraception and adolescents. Pediatrics. 1990 Jul;86(1):134-8. No abstract available.

    PMID: 2359670BACKGROUND

  • Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. Natl Health Stat Report. 2012 Oct 18;(60):1-25.

    PMID: 24988814BACKGROUND

  • Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.

    PMID: 17138775BACKGROUND

  • Cwiak C, Gellasch T, Zieman M. Peripartum contraceptive attitudes and practices. Contraception. 2004 Nov;70(5):383-6. doi: 10.1016/j.contraception.2004.05.010.

    PMID: 15504377BACKGROUND

  • Hladky KJ, Allsworth JE, Madden T, Secura GM, Peipert JF. Women's knowledge about intrauterine contraception. Obstet Gynecol. 2011 Jan;117(1):48-54. doi: 10.1097/AOG.0b013e318202b4c9.

    PMID: 21173643BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

July 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)