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Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial

NCT ID: NCT01539759

Last Updated: 2017-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-08-31

Brief Summary

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This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.

Detailed Description

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Conditions

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Intrauterine Devices Cesarean Section

Keywords

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Postpartum Contraception Intrauterine Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Interval IUD Placement

Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery

Group Type NO_INTERVENTION

No interventions assigned to this group

Immediate Postplacental IUD placement

Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta

Group Type EXPERIMENTAL

Immediate Postplacental Placement of an IUD during cesarean delivery

Intervention Type DEVICE

Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

Interventions

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Immediate Postplacental Placement of an IUD during cesarean delivery

Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women ages 18-45
* Pregnant and greater than or equal to 24 weeks of estimated gestational age
* Live Pregnancy
* States a plan to use an Intrauterine Device (IUD) postpartum for contraception
* Plan for cesarean delivery
* Intend to stay in the Chapel Hill area for at least 6 months after birth
* Fluent in English or Spanish

Exclusion Criteria

* known uterine anomalies
* allergies to any component of the IUD of their choosing
* known or suspected carcinoma of the breast
* known acute liver disease or liver tumor (benign or malignant)
* known or suspected uterine or cervical neoplasia
* active pelvic inflammatory disease
* genital bleeding of unknown etiology
* history of solid organ transplantation
* positive test for gonorrhea or chlamydia during this pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Erika Levi, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erika Levi, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.

Reference Type DERIVED
PMID: 26241250 (View on PubMed)

Other Identifiers

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11-2477

Identifier Type: -

Identifier Source: org_study_id