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Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement (IUD)

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ClinicalTrials.gov Identifier: NCT01598662
Recruitment Status : Terminated (Unable to secure funding)
First Posted : May 15, 2012
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Elaine Stauble, University of Louisville

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Contraception
Intervention: Device: Mirena (levonorgestrel-releasing intrauterine system)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
IUD Insertion 6 Weeks After Delivery Device:Levonorgestrel-releasing intrauterine device marketed as Mirena. Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a "string check"
Immediate Post-Placental Insertion Device: Levonorgestrel-releasing intrauterine device marketed as Mirena Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum

Participant Flow:   Overall Study
    IUD Insertion 6 Weeks After Delivery   Immediate Post-Placental Insertion
STARTED   11   21 
Patients Who Received IUD   0 [1]   18 
Patients Returned for 6 wk Postpartum   0   2 
COMPLETED   0   0 
NOT COMPLETED   11   21 
Lost to Follow-up                10                17 
Physician Decision                1                2 
IUD expelled before month 6                0                2 
[1] Subjects did not return at 6 weeks for IUD insertion.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IUD Insertion 6 Weeks After Delivery Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later.
Immediate Post-placental Insertion Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed
Total Total of all reporting groups

Baseline Measures
   IUD Insertion 6 Weeks After Delivery   Immediate Post-placental Insertion   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   21   32 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11 100.0%      21 100.0%      32 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11 100.0%      21 100.0%      32 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   11   21   32 


  Outcome Measures

1.  Primary:   IUD Expulsion Rate   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nancy Alsip
Organization: University Louisville
phone: 502-852-2905
e-mail: nancy.alsip@louisville.edu



Responsible Party: Mary Elaine Stauble, University of Louisville
ClinicalTrials.gov Identifier: NCT01598662     History of Changes
Other Study ID Numbers: IUD Study B090743
First Submitted: April 13, 2012
First Posted: May 15, 2012
Results First Submitted: April 20, 2017
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018