Trial Outcomes & Findings for Immediate Postplacental IUD Insertion (NCT NCT02169869)
NCT ID: NCT02169869
Last Updated: 2019-05-01
Results Overview
Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
3 months postpartum (after delivery)
Results posted on
2019-05-01
Participant Flow
Participant milestones
| Measure |
Immediate Postplacental IUD Insertion
Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.
Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
|
6 Weeks Postpartum IUD Insertion
Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.
Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate Postplacental IUD Insertion
n=17 Participants
Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.
Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
|
6 Weeks Postpartum IUD Insertion
n=16 Participants
Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.
Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
16 Participants
n=16 Participants
|
33 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=33 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=17 Participants
|
16 Participants
n=16 Participants
|
33 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
16 participants
n=16 Participants
|
33 participants
n=33 Participants
|
PRIMARY outcome
Timeframe: 3 months postpartum (after delivery)Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.
Outcome measures
| Measure |
Immediate Postplacental IUD Insertion
n=17 Participants
Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.
Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
|
6 Weeks Postpartum IUD Insertion
n=16 Participants
Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.
Mirena: A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Paragard: A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
|
|---|---|---|
|
Proportion of Subjects With an IUD at 3 Months Postpartum
|
12 Participants
|
5 Participants
|
Adverse Events
Immediate Postplacental IUD Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 Weeks Postpartum IUD Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ob/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 5034940757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place