Patient Compliance With Long-Acting Reversible Contraception Administration

NCT ID: NCT03305081

Last Updated: 2021-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-22

Study Completion Date

2016-05-31

Brief Summary

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This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.

Detailed Description

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Randomized control trial with control group receiving LARC at 6 weeks postpartum and the study group receiving LARC in the immediate or early postpartum period. Outcomes will be measured by those who receive or do not receive LARC either in the hospital after delivery versus 6 weeks postpartum in accordance with the study subjects' randomized designation. Secondary outcomes of bleeding profile and satisfaction will also be assessed.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate or early placement

Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum

Group Type EXPERIMENTAL

Levonorgestrel IUD, copper IUD, etonorgestrel implant

Intervention Type DEVICE

Long-acting reversible contraception

Interval placement

Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant

Group Type ACTIVE_COMPARATOR

Levonorgestrel IUD, copper IUD, etonorgestrel implant

Intervention Type DEVICE

Long-acting reversible contraception

Interventions

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Levonorgestrel IUD, copper IUD, etonorgestrel implant

Long-acting reversible contraception

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant, desires LARC postpartum

Exclusion Criteria

* Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tulane University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Junya, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University School of Medicine

Locations

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Tulane Department of Obstetrics and Gynecology

New Orleans, Louisiana, United States

Site Status

Countries

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United States

References

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Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.

Reference Type RESULT
PMID: 20966692 (View on PubMed)

Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.

Reference Type RESULT
PMID: 21843688 (View on PubMed)

Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 May 12;(5):CD003036. doi: 10.1002/14651858.CD003036.pub2.

Reference Type RESULT
PMID: 20464722 (View on PubMed)

Guazzelli CA, de Queiroz FT, Barbieri M, Torloni MR, de Araujo FF. Etonogestrel implant in postpartum adolescents: bleeding pattern, efficacy and discontinuation rate. Contraception. 2010 Sep;82(3):256-9. doi: 10.1016/j.contraception.2010.02.010. Epub 2010 Mar 29.

Reference Type RESULT
PMID: 20705154 (View on PubMed)

Levi E, Cantillo E, Ades V, Banks E, Murthy A. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception. 2012 Aug;86(2):102-5. doi: 10.1016/j.contraception.2011.11.019. Epub 2012 Jan 20.

Reference Type RESULT
PMID: 22264666 (View on PubMed)

Shukla M, Qureshi S; Chandrawati. Post-placental intrauterine device insertion--a five year experience at a tertiary care centre in north India. Indian J Med Res. 2012 Sep;136(3):432-5.

Reference Type RESULT
PMID: 23041736 (View on PubMed)

Stuart GS, Bryant AG, O'Neill E, Doherty IA. Feasibility of postpartum placement of the levonorgestrel intrauterine system more than 6 h after vaginal birth. Contraception. 2012 Apr;85(4):359-62. doi: 10.1016/j.contraception.2011.08.005. Epub 2011 Sep 28.

Reference Type RESULT
PMID: 22067759 (View on PubMed)

Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.

Reference Type RESULT
PMID: 19913145 (View on PubMed)

Celen S, Sucak A, Yildiz Y, Danisman N. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception. 2011 Sep;84(3):240-3. doi: 10.1016/j.contraception.2011.01.006. Epub 2011 Feb 21.

Reference Type RESULT
PMID: 21843687 (View on PubMed)

Other Identifiers

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IRBNet ID 628424-1

Identifier Type: -

Identifier Source: org_study_id

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