NCT01443533

Brief Summary

This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. It informs patients about long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine device. The investigators hypothesize that women who are randomized to receive the LARC script will be more likely to report that they are using a LARC method, when queried immediately after their six-week postpartum visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

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

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

September 27, 2011

Last Update Submit

June 26, 2012

Conditions

Contraception

Keywords

ContraceptionContraception behaviorPostnatal careHealth educationRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Self-reported use of LARC method

    After six-week postpartum visit

Secondary Outcomes (3)

  • Self-reported interest in use of a LARC method

    After six-week postpartum visit

  • Self-reported use of any contraceptive method

    After six-week postpartum visit

  • Self-reported reasons for not using the contraceptive method of choice

    After six-week postpartum visit

Study Arms (2)

LARC script

EXPERIMENTAL

Received routine postpartum counseling and LARC script.

Behavioral: LARC Script

No LARC script

NO INTERVENTION

Received only routine postpartum counseling

Interventions

LARC ScriptBEHAVIORAL

The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.

LARC script

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who are admitted to the postpartum unit at WakeMed Hospital
  • Delivery of a live infant \>24 weeks gestational age
  • Age 14-45 years
  • Ability to speak either English or Spanish fluently
  • Willing to be contacted by phone until at least 8 weeks after delivery

You may not qualify if:

  • History of a tubal ligation or hysterectomy
  • Partner has already had a vasectomy
  • History of fertility treatment to conceive this pregnancy
  • Previous randomization into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

Location

Related Publications (5)

  • 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

  • Lopez LM, Hiller JE, Grimes DA. Postpartum education for contraception: a systematic review. Obstet Gynecol Surv. 2010 May;65(5):325-31. doi: 10.1097/OGX.0b013e3181e57127.

    PMID: 20591202BACKGROUND

  • 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

  • Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23. doi: 10.1001/jama.295.15.1809.

    PMID: 16622143BACKGROUND

  • Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Womens Health Issues. 2015 Nov-Dec;25(6):616-21. doi: 10.1016/j.whi.2015.06.004. Epub 2015 Jul 23.

    PMID: 26212318DERIVED

MeSH Terms

Conditions

Contraception BehaviorHealth Education

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2011

First Posted

September 29, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

US(1)