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Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study

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ClinicalTrials.gov Identifier: NCT01309919
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Katharine White, Baystate Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Postpartum Period
Interventions Device: IUD
Other: Diary
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intrauterine Device (IUD) Arm Diary Arm
Hide Arm/Group Description

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

Period Title: Overall Study
Started 75 75
Completed 58 27
Not Completed 17 48
Reason Not Completed
Did not receive a postpartum IUD             17             48
Arm/Group Title IUD Arm Diary Arm Total
Hide Arm/Group Description

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
25  (5) 24  (5) 24.5  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
75
 100.0%
75
 100.0%
150
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Hispanic or Latino
47
  62.7%
38
  50.7%
85
  56.7%
Not Hispanic or Latino
27
  36.0%
37
  49.3%
64
  42.7%
Unknown or Not Reported
1
   1.3%
0
   0.0%
1
   0.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
White 53 49 102
Black 8 14 22
Other 14 12 26
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 75 participants 75 participants 150 participants
32.4  (7) 31.6  (7) 32  (7)
1.Primary Outcome
Title Bleeding Patterns
Hide Description Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum
Time Frame 12 weeks post-partum
Hide Outcome Measure Data
Hide Analysis Population Description
We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)
Arm/Group Title IUD Arm Diary Arm
Hide Arm/Group Description:

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

Overall Number of Participants Analyzed 25 27
Median (Full Range)
Unit of Measure: days
First 6 wks PP - Bleeding
15
(6 to 42)
18
(8 to 42)
First 6 wks PP - Spotting
13
(0 to 29)
7
(0 to 33)
Second 6wks PP - Bleeding
5.5
(0 to 42)
8
(0 to 42)
Second 6wks PP - Spotting
7.5
(0 to 42)
4
(0 to 30)
2.Secondary Outcome
Title Expulsions
Hide Description Incidence of spontaneous IUD expulsion in the six months after insertion
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
We assessed the number of expelled IUDs for all participants who had an IUD placed
Arm/Group Title IUD Arm Diary Arm
Hide Arm/Group Description:

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

Overall Number of Participants Analyzed 58 0
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Satisfaction
Hide Description Participant satisfaction with the IUD at 12 weeks post-insertion
Time Frame 12 weeks post-partum
Hide Outcome Measure Data
Hide Analysis Population Description
We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call
Arm/Group Title IUD Arm Diary Arm
Hide Arm/Group Description:

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

Overall Number of Participants Analyzed 44 0
Measure Type: Number
Unit of Measure: % of participants who received an IUD
Very satisfied 82
Somewhat satisfied 11
4.Secondary Outcome
Title Insertion Time
Hide Description Time of insertion of the IUD
Time Frame immediate
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IUD Arm Diary Arm
Hide Arm/Group Description:

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

Overall Number of Participants Analyzed 58 0
Mean (Standard Deviation)
Unit of Measure: minutes
5.5  (4.3)
Time Frame Adverse event data were collected for 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IUD Arm Diary Arm
Hide Arm/Group Description

Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)

IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

Diary: Subjects will keep a bleeding diary for three months

Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all

Diary: Subjects will keep a bleeding diary for three months

All-Cause Mortality
IUD Arm Diary Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IUD Arm Diary Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (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 Arm Diary Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%) 
Low rate of bleeding diary return limited our assessment of the primary outcome of bleeding/spotting days after delivery.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Katharine White
Organization: Baystate Medical Center
Phone: 413-794-5256
Responsible Party: Katharine White, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01309919     History of Changes
Other Study ID Numbers: BH10-190
First Submitted: March 4, 2011
First Posted: March 7, 2011
Results First Submitted: November 27, 2013
Results First Posted: January 29, 2015
Last Update Posted: January 29, 2015