NCT01539759

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 9, 2015

Completed
Last Updated

October 13, 2017

Status Verified

September 1, 2017

Enrollment Period

2.4 years

First QC Date

February 21, 2012

Results QC Date

June 16, 2015

Last Update Submit

September 12, 2017

Conditions

Intrauterine DevicesCesarean Section

Keywords

Postpartum ContraceptionIntrauterine Devices

Outcome Measures

Primary Outcomes (1)

  • IUD Use

    The use of an IUD at 6 months postpartum is the primary outcome measure

    6 months postpartum

Secondary Outcomes (2)

  • IUD Expulsion

    0-6 months postpartum

  • Women's Satisfaction With IUDs

    0-6 months postpartum

Study Arms (2)

Interval IUD Placement

NO INTERVENTION

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

Immediate Postplacental IUD placement

EXPERIMENTAL

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

Device: Immediate Postplacental Placement of an IUD during cesarean delivery

Interventions

Immediate Postplacental Placement of an IUD during cesarean deliveryDEVICE

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

Immediate Postplacental IUD placement

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

  • 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.

    PMID: 26241250DERIVED

Results Point of Contact

Title
Erika Levi, MD and Gretchen Stuart, MD
Organization
University of North Carolina
Erika.Levi@gmail.com
(919) 843-5633

Study Officials

  • Erika Levi, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 13, 2017

Results First Posted

July 9, 2015

Record last verified: 2017-09

Locations

US(1)