Study of Birth Control Use After Childbirth

NCT ID: NCT01443533

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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LARC script

Received routine postpartum counseling and LARC script.

Group Type EXPERIMENTAL

LARC Script

Intervention Type BEHAVIORAL

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

No LARC script

Received only routine postpartum counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LARC Script

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

WakeMed Health and Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Jennifer H. Tang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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WakeMed Hospital

Raleigh, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20541171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20591202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17138775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16622143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26212318 (View on PubMed)

Other Identifiers

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WakeMed 864

Identifier Type: -

Identifier Source: org_study_id

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