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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 : September 25, 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)
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IUD Insertion 6 Weeks After Delivery Immediate Post-Placental Insertion
Hide Arm/Group Description 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" 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
Period Title: Overall Study
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
Reason Not Completed
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.
Arm/Group Title IUD Insertion 6 Weeks After Delivery Immediate Post-placental Insertion Total
Hide Arm/Group Description Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed Total of all reporting groups
Overall Number of Baseline Participants 11 21 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 21 participants 32 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 21 participants 32 participants
Female
11
 100.0%
21
 100.0%
32
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 21 participants 32 participants
11 21 32
1.Primary Outcome
Title IUD Expulsion Rate
Hide Description The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
0 participants were evaluable in the Arm "IUD Insertion 6 Weeks After Delivery", as 0 participants received an IUD at 6 weeks, and 2 participants in the Arm "Immediate Post-placental Insertion" were evaluable, as there were only 2 participants that came back for a follow up appointment.
Arm/Group Title IUD Insertion 6 Weeks After Delivery Immediate Post-placental Insertion
Hide Arm/Group Description:
Subjects randomized had their IUD placed in the office at six weeks postpartum or later.
Subjects randomized to immediate post-placental placement within 10 minutes of delivery had an IUD placed manually under sterile technique and with ultrasound guidance
Overall Number of Participants Analyzed 0 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
2
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IUD Insertion 6 Weeks After Delivery Immediate Post-placental Insertion
Hide Arm/Group Description Subjects randomized had their IUD placed in the office at six weeks postpartum or later. Subjects randomized to immediate post-placental placement within 10 minutes of delivery had an IUD placed manually under sterile technique and with ultrasound guidance
All-Cause Mortality
IUD Insertion 6 Weeks After Delivery Immediate Post-placental Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IUD Insertion 6 Weeks After Delivery Immediate Post-placental Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IUD Insertion 6 Weeks After Delivery Immediate Post-placental Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/21 (0.00%) 
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
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: September 25, 2018