NCT01439802

Brief Summary

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
11.3 years until next milestone

Results Posted

Study results publicly available

December 29, 2022

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

September 21, 2011

Results QC Date

October 31, 2022

Last Update Submit

April 5, 2023

Conditions

Intrauterine Device Expulsion

Keywords

Postpartum IUDCesarean Delivery6 months postpartumsatisfaction

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Expulsion of IUD

    Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

    6 week postpartum

Secondary Outcomes (2)

  • Satisfaction of IUD Placement

    6 months postpartum

  • Number of Participants With Expulsion of IUD

    6 months postpartum

Interventions

Copper IUD placement at time Cesarean Delivery (Copper T 380A)DEVICE

Placement of Paragard IUD at time of Cesarean Delivery

Also known as: Copper T 380A

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton gestation
  • greater than 35 weeks gestation
  • speaks English or Spanish
  • desires IUD for contraception
  • undergoing a cesarean delivery

You may not qualify if:

  • evidence of chorioamnionitis
  • history of chlamydia within this pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center, Weiler Division

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Erika Levi
Organization
Albert Einstein College of Medicine
elevi@montefiore.org
718-405-8260

Study Officials

  • Amitasrigowri Murthy, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 23, 2011

Study Start

August 1, 2008

Primary Completion

November 1, 2009

Study Completion

May 1, 2010

Last Updated

April 7, 2023

Results First Posted

December 29, 2022

Record last verified: 2023-04

Locations

US(2)