ClinicalTrials.gg
CompletedNCT01443533Updated Jun 28, 2012

Study of Birth Control Use After Childbirth

An interventional study of LARC Script in Contraception, sponsored by WakeMed Health and Hospitals. Completed at 1 site in United States. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-28.

Sponsored by WakeMed Health and Hospitals · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
14 Years to 45 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Contraception

Keywords

  • Contraception
  • Contraception behavior
  • Postnatal care
  • Health education
  • Randomized controlled trial
03

In context

Contraception Behavior

37 studies on the registry are indexed under Contraception Behavior; 14 are open to participants now.

This study's enrollment of 800 is close to the median of 773 across 32 interventional studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

WakeMed Health and Hospitals is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
800 participants (actual)

Study arms

  • Experimental
    LARC script

    Received routine postpartum counseling and LARC script.

    Behavioral: LARC Script

  • No intervention
    No LARC script

    Received only routine postpartum counseling

Interventions

  • BehavioralLARC Script

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

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What researchers measure

Primary outcomes

  1. Self-reported use of LARC method

    Time frame: After six-week postpartum visit

Secondary outcomes

  1. Self-reported interest in use of a LARC method

    Time frame: After six-week postpartum visit

  2. Self-reported use of any contraceptive method

    Time frame: After six-week postpartum visit

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

    Time frame: After six-week postpartum visit

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Study locations

1 site
  • WakeMed Hospital
    Raleigh, North Carolina 27610, United States
08

References and documents

Publications

  • 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. PubMed 20541171 ↗
  • 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. PubMed 20591202 ↗
  • 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. PubMed 17138775 ↗
  • 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. PubMed 16622143 ↗
  • 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. PubMed 26212318 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01443533
Lead sponsor
WakeMed Health and Hospitals
Responsible party
Jennifer H. Tang (Principal Investigator, University of North Carolina, Chapel Hill) — Principal investigator
First posted
Sep 29, 2011
Start date
May 2011
Primary completion
May 2012
Completion
May 2012
Last update
Jun 28, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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